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Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Rahway, New Jersey. The company does business as Merck Sharp & Dohme or MSD outside the United States and Canada. The company is ranked fourth on the list of largest biomedical companies by revenue.

Key Information

The company's revenues are primarily from cancer treatments, vaccines, and animal health products. In 2024, 46% of the company's revenue, or $29.5 billion, came from sales of Keytruda (pembrolizumab), a PD-1 inhibitor used to treat various types of cancers, and 13% of the company's revenue, or $8.6 billion, came from sales of Gardasil, an HPV vaccine.[1] In addition, 9% of the company's revenue, or $5.8 billion, came from the sales of animal health products.[1]

The company is ranked 65th on the Fortune 500[2] and 76th on the Forbes Global 2000.[3]

In 1891, Merck & Co. was established as the American affiliate of Merck Group, founded by the Merck family, and the companies are still in trademark disputes in several countries over the right to use the name "Merck".

History

[edit]

Roots and early history

[edit]
Main article: Merck Group
The Angel Pharmacy in Darmstadt, the beginning of the Merck Group

Merck & Co. traces its origins to its former German parent company Merck Group, which was established by the Merck family in 1668 when Friedrich Jacob Merck purchased a pharmacy in Darmstadt.[4][5] In 1827, Merck Group evolved from a pharmacy to a drug manufacturer company with the commercial manufacture of morphine.[6] Merck perfected the chemical process of deriving morphine from opium and later introduced cocaine, used to treat sinus problems and to add to beverages to boost energy levels.[7]

In 1887 a German-born, long-time Merck employee, Theodore Weicker, went to the United States to represent Merck Group.[8] In 1891, with $200,000 received from E. Merck, Weicker started Merck & Co., with headquarters in lower Manhattan. That year George Merck, the 23-year-old son of the then head of E. Merck (and grandson of the founder) joined Weicker in New York.[9][4][5] Merck & Co. operated from 1891 to 1917 as the US subsidiary of the Merck Group.[5]

Nationalization

[edit]

After the U.S. entered World War I, due to its German connections, Merck & Co. was the subject of expropriation under the Trading with the Enemy Act of 1917.[10] The government seized 80 percent of the shares owned by the German parent company and sold it.[11] In 1919, George F. Merck (head of the American branch of the Merck family), in partnership with Goldman Sachs and Lehman Brothers, bought the company back at a U.S. government auction for $3.5 million, but Merck & Co. remained a separate company from its former German parent.[12][13] Merck & Co. holds the trademark rights to the "Merck" name in the United States and Canada, while its former parent company retains the rights in the rest of the world; the right to use the Merck name was the subject of litigation between the two companies in 2016.[14][15][16][17]

In 1925, George W. Merck succeeded his father George F. Merck as president. In 1927, the corporation merged with the Powers-Weightman-Rosengarten Company, a Philadelphia quinine manufacturer. George Merck remained president and Frederic Rosengarten became chairman of the board.[18][19] In 1929, H. K. Mulford Company merged with Sharp and Dohme, Inc. and brought vaccine technology, including immunization of cavalry horses in World War I and delivery of a diphtheria antitoxin to Merck & Co.

In 1943, streptomycin was discovered during a Merck-funded research program in Selman Waksman's laboratory at Rutgers University. It became the first effective treatment for tuberculosis. At the time of its discovery, sanatoriums for the isolation of tuberculosis-infected people were a ubiquitous feature of cities in developed countries, with 50% dying within 5 years of admission.[20][21] Although Merck's agreement with Rutgers gave it exclusive rights to streptomycin, at Waksman's request the company renegotiated the agreement, returning the rights to the university in exchange for a royalty. The university then set up non-exclusive licenses with seven companies to ensure a reliable supply of the antibiotic.[22]

1950–2000

[edit]

In the 1950s, thiazide diuretics were developed by Merck scientists Karl H. Beyer, James M. Sprague, John E. Baer, and Frederick C. Novello[23] and led to the marketing of the first drug of this class, chlorothiazide, under the trade name Diuril in 1958.[24] The research leading to the discovery of chlorothiazide, leading to "the saving of untold thousands of lives and the alleviation of the suffering of millions of victims of hypertension" was recognized by a special Public Health Award from the Lasker Foundation in 1975.[25]

In 1953, Merck & Co. merged with Philadelphia-based Sharp & Dohme, Inc., becoming the largest U.S. drugmaker. Sharp and Dohme had acquired H. K. Mulford Company in 1929, adding smallpox vaccines to its portfolio.[26][27][28][29][30][4] The combined company kept the trade name Merck in the United States and Canada, and as Merck Sharp & Dohme (MSD) outside North America.[17]

In 1965, Merck & Co. acquired Charles Frosst Ltd. of Montreal (founded 1899), creating Merck-Frosst Canada, Inc., as its Canadian subsidiary and pharmaceutical research facility. Merck & Co. closed this facility in July 2010 but remerged in 2011 as Merck Canada.[31][32]

Maurice Hilleman, a scientist at Merck, developed the first mumps vaccine in 1967,[33] the first rubella vaccine in 1969,[34] and the first trivalent measles, mumps, rubella (MMR vaccine) in 1971.[35] The incidence of rubella-associated birth defects fell from up to 10,000 per year in the U.S. to zero in the aftermath of the rubella vaccine's development.[36] Hilleman also developed the first Hepatitis B vaccine and the first varicella vaccine, for chickenpox.[37]

The company was incorporated in New Jersey in 1970. John J. Horan became CEO and Chairman in 1976, serving until 1985.[38] Under his leadership, the company's investment in R&D grew threefold, and Merck became the largest pharmaceutical company in the world.[38][39]

In 1979, Merck scientists developed lovastatin (Mevacor), the first drug of the statin class.[40]

Merck scientist William C. Campbell and Satoshi Ōmura developed ivermectin for veterinary use in 1981, and later put it to human use against onchocerciasis in 1987–1988 with the name Mectizan; today the compound is also used against lymphatic filariasis, scabies and other parasitic infections.[41][42]

In 1982, the company formed a joint venture, KBI Inc., with AstraZeneca.[43] During the late 1980s and 1990s, the company also established joint ventures with DuPont to access research and development expertise, and with Johnson & Johnson to sell over-the-counter consumer medications.[citation needed]

In 1985, Merck received approval for imipenem, the first member of the carbapenem class of antibiotics. Antibiotics of the carbapenem class play an important role in treatment guidelines for certain hospital-acquired and multi-drug resistant infections.[44] P. Roy Vagelos became CEO and Chairman that year, succeeding Horan.[45] Vagelos served until reaching the company's mandatory retirement age in 1994, succeeded by Raymond Gilmartin.[46]

In 1991, Merck's Kelco subsidiary was responsible for volatile organic compound (VOC) emission pollution in the San Diego area. In 1996 Merck paid $1.8 million for polluting the air. New machines were installed to reduce smog emissions by 680,000 lb (310,000 kg) a year.[47]

In November 1993, Merck & Co. acquired Medco Containment Services for $6 billion.[48][49] Merck & Co. spun Medco off ten years later.[50]

Merck's supply chain reduction programme has been referred to as an example of successful change. Merck reduced its number of global suppliers from 40,000 to less than 10,000 during the period from 1992 to 1997.[51]

2001–2019

[edit]
Merck Research Laboratories in South San Francisco, California

In May 2002, The Bill & Melinda Gates Foundation purchased stock in Merck.[52]

From 2002 through 2005, the Australian affiliate of Merck paid publishing house Elsevier an undisclosed amount to produce eight issues of a medical journal, the Australasian Journal of Bone and Joint Medicine. Although it gave the appearance of being an independent peer-reviewed journal, without any indication that Merck had paid for it, the journal actually reprinted articles that originally appeared in other publications and that were favorable to Merck. The misleading publication came to light in 2009 during a personal injury lawsuit filed over Vioxx; 9 of 29 articles in the journal's second issue referred positively to Vioxx.[53][54] The CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".[55]

In 2005, Gilmartin retired as CEO following Merck's voluntary worldwide withdrawal of Vioxx. Gilmartin's tenure was criticized as abandoning Vagelos' commitment to corporate social responsibility.[46][56] Former president of manufacturing Richard Clark was named CEO and company president.[57]

In November 2009, Merck & Co. completed a merger with Schering-Plough in a US$41 billion deal.[58][59] Although Merck & Co. was in reality acquiring Schering-Plough, the purchase was declared a "reverse merger", in which "Old" Merck & Co. was renamed Merck Sharp & Dohme, and Schering-Plough renamed as "Merck & Co., Inc.[60] The maneuver was an attempt avoid a "change-of-control" in order to preserve Schering-Plough's rights to market Remicade. A settlement with Johnson & Johnson was reached in 2011, in which Merck agreed to pay $500 million.[61][62] Merck Sharp & Dohme remains a subsidiary of the Merck & Co. parent.[1]

Richard Clark retired as CEO and company president in October 2011 and Kenneth Frazier became CEO.[63]

In October 2013, Merck announced it would cut 8,500 jobs in an attempt to cut $2.5 billion from its costs by 2015. Combined with 7,500 job cuts announced in 2011 and 2012, the layoffs amounted to 20% of its workforce.[64][65]

By 2014, research performed at Merck has led to U.S. FDA approval of 63 new molecular entities.[66]

In August 2014, Merck acquired Idenix Pharmaceuticals for $3.85 billion.[67][68]

In September 2014, the US Food and Drug Administration (FDA) approved Pembrolizumab (MK-3475) as a breakthrough therapy for melanoma treatment.[69] In clinical trials, pembrolizumab provided partial tumor regression in about one quarter of patients, many of whom have not seen further progression of their disease in over 6 months of follow-up.[70]

In December 2014, the company acquired Swiss biotechnology company OncoEthix for up to $375 million.[71][72]

Between 2010 and 2015, the company cut around 36,450 jobs.[73] During that time, the company sold its consumer health business to Bayer and narrowed the company's focus to immunology, vaccines, diabetes, emerging markets and medicines used in hospitals, like certain antibiotics.[73]

In January 2015, Merck acquired Cubist Pharmaceuticals for $102 per share in cash or about $9.5 billion in total.[74]

In July 2015, Merck and Ablynx expanded their 18-month-old immuno-oncology collaboration by four years, generating a potential $4.4 billion in milestone payments for the Abylnx.[75] The company also announced it would spend $95 million up front collaborating with cCAM Biotherapeutics and its early-stage treatment similar to Keytruda. Merck & Co. will bring in CM-24, an antibody designed to block the immune checkpoint CEACAM1.[76]

In January 2016, Merck announced two new partnerships; the first with Quartet Medicine and its small molecule pain treatments,[77] the second with Complix investigating intracellular cancer targets,[78] with both collaborations potentially generating up to $595 million and $280 million respectively. Days later the company announced it would acquire IOmet Pharma, with IOmet becoming a wholly owned subsidiary of Merck & Co. The acquisition includes IOmets indoleamine-2,3-dioxygenase 1 (IDO), tryptophan 2,3-dioxygenase (TDO), and dual-acting inhibitors.[79]

In July 2016, the company acquired Afferent Pharmaceuticals, developer of a candidate used to block P2RX3 receptors, for approximately $1 billion, plus up to $750 million in milestone payments.[80][81]

In 2017, Merck bought the PARP inhibitor Lynparza from AstraZeneca.[82]

In April 2017, Merck Animal Health acquired Vallée S.A., a Brazilian animal health product manufacturer.[83]

In September 2017, the company announced it would acquire Rigontec, developer of a candidate to target the retinoic acid-inducible gene I pathway, for $554 million.[84][85]

In October 2017, the company granted the inaugural Merck-AGITG Clinical Research Fellowship in Gastro-Intestinal (GI) Cancer to David Lau, a professional in Melbourne, Australia.[86][87]

In June 2018, Merck acquired Viralytics, an Australian viral cancer drug company, for AUD$502 million.[88]

In 2018, Merck began the submission process for a Biologics License Application to the Food and Drug Administration under the Breakthrough Therapy Designation for an investigational vaccine, called V920, to fight the Zaire strain of the Ebola virus.[89]

In April 2019, the company acquired Immune Design for approximately $300 million, gaining access to its immunotherapy programs.[90][91] It also acquired Antelliq Group for $2.4 billion, or $3.7 billion including debt.[92]

In May 2019, Merck announced it would acquire Peloton Therapeutics, developer of a HIF-2alpha inhibitor for Von Hippel–Lindau disease-associated renal cell carcinoma, for up to $2.2 billion.[93]

In June 2019, Merck announced it would acquire Tilos Therapeutics for up to $773 million.[94]

In November 2019, the company acquired Calporta, which focused on Parkinsons and Alzheimers treatments.[95]

In December 2019, Merck Animal Health acquired Vaki, an aquaculture company, from Pentair.[96]

2020–present

[edit]

In January 2020, Merck acquired ArQule, developer of ARQ 531, an oral Bruton's tyrosine kinase (BTK) inhibitor, for $2.7 billion.[97]

In March 2020, Merck was one of ten companies recognised at the inaugural Manufacturing Awards by New Jersey Business magazine and the New Jersey Business and Industry Association.[98]

In June 2020, Merck acquired Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases including COVID-19 and cancer.[99][100][101]

Also in June 2020, Merck Animal Health acquired Quantified Ag, a data and analytics company that monitors cattle body temperature and movement in order to detect illness early.[102]

In August 2020, Merck Animal Health acquired IdentiGEN, engaged in DNA-based animal traceability.[103]

In September 2020, Merck acquired $1 billion of Seattle Genetics common stock, and agreed to co-develop ladiratuzumab vedotin.[104][105]

In November 2020, Merck announced it would acquire VelosBio for $2.75 billion, developer of VLS-101, an antibody-drug conjugate designed to target Tyrosine kinase-like orphan receptor 1 (ROR1) in both hematological and solid tumors. VLS-101 is currently Phase I and Phase II clinical trials.[106] The company also announced it would acquire OncoImmune for $425 million and its phase 3 candidate, CD24Fc, used in the treatment of patients with severe and critical COVID-19.[107][108]

In February 2021, Merck Animal Health acquired PrognostiX Poultry.[109]

In April 2021, Merck acquired Pandion Therapeutics for $1.85 billion, expanding its offering in treating autoimmune diseases.[110][111][112]

In June 2021, the U.S. government agreed to spend $1.2 billion to purchase 1.7 million doses of Molnupiravir, a Merck product, if it were to be approved by regulators to treat COVID-19.[113] In October 2021, the company said that the drug reduces the risk of hospitalization or death by around 50% for patients with mild or moderate cases of COVID-19 and that it would seek Emergency Use Authorization for the drug.[114]

In July 2021, Robert M. Davis became CEO, succeeding Kenneth Frazier, who became executive chairman.[115][116][117][118]

In July 2021, Merck completed the corporate spin-off of Organon & Co.[119]

In September 2021, Merck announced it would acquire Acceleron Pharma for $11.5 billion, gaining control over Sotatercept, used in the treatment of pulmonary hypertension, and luspatercept-aamt.[120]

In September 2022, the company announced it would acquire Vence, a livestock management company for an undisclosed sum, incorporating it within Merck Animal Health.[121]

In December 2022, the company announced a licensing deal with Kelun-Biotech of China whereby it would expand its early cancer pipeline with a set of antibody-drug conjugates; this follows an earlier agreement between the two companies to co-develop such drugs.[122]

In April 2023, Merck announced it would acquire Prometheus Biosciences Inc for $10.8 billion.[123]

In December 2023, Merck announced it had partnered with Owkin to develop artificial intelligence-powered digital pathology diagnostics that could be used to identify patients suitable for immunotherapies. The aim is to come up with tools that can pre-screen patients with four tumour types for the MSI-H biomarker, namely endometrial, gastric, small intestinal, and biliary cancers.[124]

In January 2024, the company announced it would acquire Harpoon Therapeutics for $680 million.[125] With this purchase, Merck expands its portfolio of oncological drugs. The main positions are HPN328, an activator of T-cells that is being researched to treat advanced cancer patients associated with DLL3 expression (delta-like ligand 3), an inherent small cell lung cancer (SCLC), neuroendocrine tumors, and several other species. Merck's portfolio will also be complemented by T-cell attractions using the patented Harpoon Tri-specific design for T cell activation (TriTAC). According to engineering protein technology, tumor cells are destroyed by the patient's own immune cells, and the ProTriTAC platform works with the TriTAC platform to develop a therapeutic agent that attracts T-cells, but is inactive until it reaches the tumor.[126]

In April 2024, Merck completed the acquisition of Abceutics for $208 million.[127]

In July 2024, Merck completed the acquisition of EyeBio for $3 billion.[128]

In October 2024, Merck announced the acquisition of Modifi Biosciences for $1.3 billion.[129]

Acquisition history

[edit]
Merck & Co Acquisitions
  • Merck & Co (Founded in 1891 as the US subsidiary of Merck of Darmstadt, later Nationalised by the US government in 1917 during the first World War)
    • Merck & Co
      • Merck & Co
        • H. K. Mulford Company (Acq 1929)
        • Sharp & Dohme, Inc (Acq 1953)
        • Charles E. Frosst Ltd (Acq 1965, restructured into Merck-Frosst Canada, Inc, restructured into Merck Canada in 2011)
        • Medco Containment Services Inc (Acq 1993, Spun off 2003)
      • Schering‑Plough
        • Schering-Plough (Merged 1971)
          • Schering Corporation (Founded 1851)
          • Plough, Inc (Founded 1908)
        • Organon International
          • Alydia Health (Acq 2021)
        • Intervet
        • Diosynth
        • Nobilon
    • Imperial Blue Corporation[130]
      • Idenix Pharmaceuticals (Acq 2014)
    • Maven Corporation[131]
    • OncoEthix (Acq 2015)
    • IOmet Pharma (Acq 2016)
    • Afferent Pharmaceuticals (Acq 2016)
    • Merck Animal Health
      • Vallée S.A. (Acq 2017)
      • Vaki (Acq 2019)
      • Quantified Ag (Acq 2020)
      • IdentiGEN (Acq 2020)
      • PrognostiX Poultry Ltd (Acq 2021)
      • Vence (Acq 2022)
    • Rigontec (Acq 2017)
    • Viralytics (Acq 2018)
    • Antelliq Group (Acq 2018)
    • Cascade Merger Sub, Inc.[132]
      • Immune Design Corp (Acq 2019)
    • Peloton Therapeutics (Acq 2019)
    • Tilos Therapeutics (Acq 2019)
    • Calporta (Acq 2019)
    • Argon Merger Sub, Inc.
      • ArQule, Inc. (Acq 2019)
    • Themis Bioscience (Acq 2020)
    • VelosBio (Acq 2020)
    • OncoImmune (Acq 2020)
    • Astros Merger Sub, Inc.
    • Prometheus Biosciences (Acq 2023)
    • Caraway Therapeutics (Acq 2023)
    • Harpoon Therapeutics (Acq 2024)
    • Abceutics (Acq 2024)
    • EyeBio (Acq 2024)
    • Modifi Biosciences (Acq 2024)
    • Verona Pharma plc (Acq 2025)[133]

Products

[edit]
Gardasil 9 in French packaging (showing the MSD branding)

Details of Merck's major products are as follows:[1]

Oncology

[edit]

Vaccines

[edit]

Hospital acute care

[edit]

Cardiology

[edit]

Neuroscience

[edit]

Virology

[edit]

Immunology

[edit]

Diabetes

[edit]
  • Januvia (sitagliptin) ($1.3 billion in 2024 revenues) is a dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. In 2013, Januvia was the second largest selling diabetes drug worldwide.[139] It has been popular due in part because unlike many other diabetes drugs, it causes little or no weight gain and is not associated with hypoglycemic episodes.[140][141] There has been some concern that treatment with Januvia and other DPP-IV inhibitors may be associated with a modestly increased risk of pancreatitis.[142]
  • Janumet ($1.0 billion in 2024 revenues) is a single pill combination drug containing both Januvia and metformin.

Animal health

[edit]
  • Livestock products ($3.4 billion in 2024 revenues) include various medications and vaccines for cattle and poultry.
  • Companion animal products ($2.4 billion in 2024 revenues) include various medications and vaccines for cats, dogs, and horses.

Philanthropy

[edit]

Philanthropic initiatives by Merck include:

  • Merck Foundation - founded in 1957, the foundation has donated over $1 billion to charitable causes to promote health equity. In 2012, the foundation ended its donations to the Boy Scouts of America citing its discrimination against gay people.[143]
  • Patient assistance programs to offer access to pharmaceuticals to those unable to afford its medications.
  • Provides funding to Hilleman Laboratories, an India-based non-profit research organization dedicated to the development of low-cost vaccines for use in developing countries.[144]
  • Merck for Mothers prevents maternal mortality.
  • Merck produces Mectizan (ivermectin), an anti-parasitic medicine traditionally used to treat onchocerciasis, solely for donation to people in Africa, Latin America, and Yemen. The donation program has significantly reduced the incidence of the disease.

Lawsuits and controversies

[edit]

Heart attacks after use of Vioxx

[edit]

In 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx (known generically as rofecoxib), a Merck product for treating arthritis. Vioxx was designed as a selective inhibitor of the enzyme cyclooxygenase-2. Such compounds were expected to cause less gastrointestinal bleeding than older anti-inflammatory drugs such as naproxen, which were associated with 20,000 hospitalizations and 2000 deaths each year.[145][non-primary source needed] Vioxx became one of the most prescribed drugs in history.[146]

Thereafter, studies by Merck and by others found an increased risk of heart attack associated with Vioxx use when compared with naproxen. Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks in 2002.[147]

On September 23, 2004, Merck received information about results from a clinical trial it was conducting that included findings of increased risk of heart attacks among Vioxx users who had been using the medication for over eighteen months.[148] On September 28, 2004, Merck notified the FDA that it was voluntarily withdrawing Vioxx from the market, and it publicly announced the withdrawal on September 30. An analysis for the period 1999–2004, based on U.S. Medical Expenditure Survey data, reported that Vioxx was associated with 46,783 heart attacks in the US, and along with the other popular COX-2 inhibitor Celebrex, an estimated 26,603 deaths from both.[149][150]

About 50,000 people sued Merck, claiming they or their family members had suffered medical problems such as heart attacks or strokes after taking Vioxx.[151] In November 2007, Merck agreed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[152] The settlement required that claimants provide medical and pharmacy records confirming the occurrence of a heart attack, ischemic stroke, or sudden cardiac death; the receipt of at least 30 Vioxx pills within 60 days prior to the injury or death; and confirmation of Vioxx being used within 14 days of the Vioxx-related event.[153] The settlement was generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached between $10 billion and $25 billion.[152] As of mid-2008, when the plaintiff class had reached the threshold percentage required by Merck to go through with the settlement, plaintiffs had prevailed in only three of the twenty cases that had reached juries, all with relatively small awards.[151]

Merck has refused to consider compensation for Vioxx victims and their families outside the US. This is particularly true in the UK where there are at least 400 victims and the legal protection afforded to the victims and their families is particularly weak.[154]

According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralized" or "discredited". "We may need to seek them out and destroy them where they live," wrote an employee. A Stanford Medical School professor said that Merck was engaged in intimidation of researchers and infringement upon academic freedom.[155]

On May 20, 2008, Merck settled for $58 million with 30 states alleging that Merck engaged in deceptive marketing tactics to promote Vioxx.[156] All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.[157]

Osteonecrosis of the jaw after use of Fosamax

[edit]

Fosamax (alendronate) is a bisphosphonate used for the treatment of post-menopausal osteoporosis and for the prevention of skeletal problems in certain cancers. The American College of Clinical Endocrinology, the American College of Obstetricians and Gynecologists, the North American Menopause Society and the UK National Osteoporosis Guideline Group recommend alendronate and certain other bisphosphonates as first line treatments for post-menopausal osteopotosis.[158][159][160] Long-term treatment with bisphosponates produces anti-fracture and bone mineral density effects that persist for 3–5 years after an initial 3–5 years of treatment.[161] Alendronate reduces the risk of hip, vertebral, and wrist fractures by 35-39%.[162][163]

In December 2013, Merck agreed to pay a total of $27.7 million to 1,200 plaintiffs in a class action lawsuit alleging that the company's osteoporosis drug had caused them to develop osteonecrosis of the jaw. Prior to the settlement, Merck had prevailed in 3 of 5 so-called bellwether trials. Approximately 4,000 cases still await adjudication or settlement as of August 2014.[164]

There have also been thousands of lawsuits alleging that Fosamax increased the risk of thigh-bone fractures.[165] In March 2022, Merck defeated approximately 500 lawsuits over Fosamax in New Jersey when U.S. District Judge Freda L. Wolfson ruled that the plaintiffs' lawsuit was preempted by federal law.[166] On September 20, 2024, the United States Court of Appeals for the Third Circuit overturned that decision, holding that federal law did not block plaintiffs' state law claims against Merck over Fosamax.[165] As of June 30, 2024, about 3,115 lawsuits over Fosamax were still pending against Merck in both federal and state courts in the United States.[165]

Medicaid overbilling

[edit]

A fraud investigation by the United States Department of Justice began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act.[167] They alleged that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration to health care providers.[168] On February 7, 2008, Merck agreed to pay more than $650 million to settle charges that it routinely overbilled Medicaid for its most popular medicines. The settlement was one of the largest pharmaceutical settlements in history. The federal government received more than $360 million, plus 49 states and Washington, DC, received over $290 million. One whistleblower received a $68 million reward. Merck made the settlement without an admission of liability or wrongdoing.[167][169][170]

[edit]

In 191 of 193 countries, the original Merck company, the Merck Group of Darmstadt, owns the rights to the "Merck" name. In the United States and Canada, the company trades under the name EMD (an abbreviation of Emanuel Merck, Darmstadt), its legal name here says Merck KGaA, Darmstadt, Germany, and instead of "Merck Group", the "EMD Group" name is used. In the United States and Canada, Merck & Co. holds the rights to the trademark "Merck", while in the rest of the world the company trades under the name MSD (an abbreviation of Merck, Sharp & Dohme) and its legal name says here Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. Kenilworth, NJ, USA.

In 2015 the Merck Group adopted a new logo and said it will be "much more aggressive" about protecting the brand of "the real Merck".[171] Merck of Darmstadt has initiated litigation against its former subsidiary, Merck & Co. (MSD) of Kenilworth, in several countries over infringing use of the Merck name. In 2016, the High Court of Justice in the United Kingdom ruled that MSD had breached an agreement with its former parent company and that only Merck of Darmstadt is entitled to use the Merck name in the United Kingdom.[17] The judge also held that MSD's use of "Merck" as part of branding on its global websites were directed to the UK and infringed Merck's trade mark rights in the UK.[172]

In response to the ruling, MSD initiated counter-litigation in the United States in January 2016 by filing a federal lawsuit which accused its former parent company of "infringing on its trademark" through actions that included the increased usage of "Merck KGaA" and "MERCK" in branding in the US as well as on its social media presence. Further Merck & Co. has also accused the Merck Group of federal trademark dilution, unfair competition, false advertising, deceptive trade practices, breach of contract, and cybersquatting. The case came to a head when a research scientist believed he was communicating with Merck & Co regarding a research grant in oncology, when in fact he was talking with the Merck Group. As a result, Merck & Co. asked the federal court to stop the Merck Group from using "Merck" on any products or marketing materials in the United States. As a direct result, Merck & Co is seeking "all monetary gains, profits, and advantages" made by the Merck Group and three-times the damage, plus additional punitive damages.[14]

In April 2020, in the course of litigation of Merck against MSD in Switzerland, the Federal Supreme Court of Switzerland ruled that MSD's use of the "Merck" brand in its global websites could, absent geotargeting mechanisms, have "commercial effect" in Switzerland and could therefore violate Merck's rights (if any) to the "Merck" brand in Switzerland.[173]

Tax implications of transaction accounting

[edit]

In February 2007, Merck paid $2.3 billion to the Internal Revenue Service to settle a tax dispute over the accounting treatment of transactions between 1993 and 2001.[174]

Sexual dysfunction and suicidal thoughts associated with Propecia

[edit]

In 2021, an investigation by Reuters revealed that Merck's baldness drug Propecia caused persistent sexual dysfunction in men.[175] The drug has been linked to over 700 incidences of suicidal thoughts[176] and 110 deaths.[175] Merck has been receiving reports since 1998, but never included the risks on the label.[175] In 2015, Merck was sued by consumer-rights law firm Hagens Berman over a wrongful death linked to Propecia.[177]

Use of methylene chloride

[edit]

Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as a solvent in some of its manufacturing processes. Merck chemists and engineers subsequently replaced the compound with others having fewer negative environmental effects. Merck has also modified its equipment to protect the environment, installing a distributed control system that coordinates chemical reactions more efficiently and expedites manufacturing by 50 percent, eliminating the need for the disposal and storage of harmful waste. Biological oxygen demand has also been reduced. In 2011, Merck paid a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside, Pennsylvania and West Point, Pennsylvania.[178]

Politics

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The company spends approximately $10 million per year on lobbying in the United States. Political contributions have mostly been to individuals and organizations associated with the Democratic Party.[179] The company is a member of many industry advocacy groups and sponsors many industry events.

Notable publications

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Merck & Co. publishes The Merck Manuals, a series of medical reference books for physicians, nurses, technicians, and veterinarians. These include the Merck Manual of Diagnosis and Therapy, the world's best-selling medical reference. The Merck Index, a compendium of chemical compounds, was published by Merck & Co. until it was acquired by the Royal Society of Chemistry in 2012.

References

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Merck & Co.

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Merck & Co., Inc. (NYSE: MRK), which operates internationally as MSD (Merck Sharp & Dohme), is an American multinational healthcare company specializing in the discovery, development, manufacturing, and commercialization of pharmaceuticals, vaccines, and animal health products. Headquartered in , the company was founded on January 1, 1891, by George Merck as a distributor of fine chemicals in , evolving from the U.S. subsidiary of the German Merck family enterprise established in 1668. Merck ranks among the world's largest pharmaceutical firms, reporting worldwide sales of $64.2 billion in 2024, with strong growth in its and portfolios. Key products include (Keytruda), a PD-1 inhibitor generating billions in annual revenue as a leading for various cancers, and 9, a preventing human papillomavirus infections linked to cervical and other cancers. The company invests heavily in , aspiring to deliver innovative solutions for major health challenges, including infectious diseases and . Merck's scientific contributions have earned recognition, such as involvement in the discovery and distribution of (Mectizan), which contributed to the 2015 in Physiology or Medicine for advancements against parasitic infections like river blindness. However, the company has encountered significant controversies, particularly the voluntary worldwide withdrawal of its COX-2 selective NSAID (Vioxx) on September 30, 2004, after a (APPROVe) demonstrated an increased risk of serious cardiovascular thrombotic events, including heart attacks and strokes, in long-term users. This led to over 27,000 lawsuits and eventual settlements totaling approximately $4.85 billion by Merck, alongside a $950 million resolution in 2011 for off-label promotion allegations.

Corporate Overview

Merck & Co. traces its origins to the German pharmaceutical firm founded in 1668 by in , which expanded internationally in the late . In 1891, George Merck, a member of the and grandson of Emanuel Merck, established the U.S. Merck & Co. on January 1 in to import and distribute fine chemicals, alkaloids, and pharmaceuticals from the German parent company. Initially operating from rented space, the firm focused on supplying physicians and pharmacies with products like and derivatives, reflecting the era's emphasis on chemical therapeutics. The U.S. entry into in 1917 triggered the legal separation, as anti-German sentiment and wartime policies led the U.S. government to seize enemy-owned assets under the Trading with the Enemy Act. On October 12, 1917, the Alien Property Custodian expropriated Merck & Co., severing ties with the German (later Merck KGaA) and placing the subsidiary under U.S. control to ensure continuity of drug supply amid shortages. George Merck, who had returned to earlier, later reacquired the firm in 1919 after proving his American loyalty through service in the U.S. Army, transforming it into an independent entity focused on domestic manufacturing and research. Post-separation, the two companies operated autonomously, with Merck & Co. retaining the name in the U.S. and Canada while Merck KGaA held rights elsewhere, leading to ongoing trademark disputes resolved through mutual agreements like the 1950s covenant allowing "Merck" usage in specified regions. This bifurcation preserved distinct corporate identities, with no shared ownership or control since 1917, though both entities continued innovating in pharmaceuticals independently. The separation underscored wartime nationalization's role in reshaping global business structures, enabling Merck & Co. to evolve into a major U.S.-based biopharmaceutical leader.

Current Operations and Global Reach

Merck & Co., headquartered in , focuses its core operations on the discovery, development, , and of pharmaceuticals, , and health products. The company employs approximately 75,000 worldwide as of , 2024, supporting activities across , production facilities, and commercial distribution. Merck maintains a global footprint, operating in over 100 countries and deriving roughly half of its revenues from the , with the remainder from international markets including , the , , , , , and . In 2024, regional sales breakdowns included approximately $14 billion from , , and ; $5.5 billion from ; $3.3 billion from ; $3.5 billion from ; and additional contributions from other areas. Outside the and , it conducts business as Merck Sharp & Dohme (MSD) to distinguish from the unrelated German Merck KGaA. Key research and development centers are located in West Point, Pennsylvania; South San Francisco and Boston, Massachusetts; ; and additional sites in . Manufacturing operations span multiple U.S. facilities, with recent expansions including a $3 billion for pharmaceutical manufacturing in —groundbreaking held in October 2025—and a $1 billion biologics facility in , initiated in April 2025. These investments, part of nearly $6 billion committed in 2025 across , , , and , aim to enhance domestic production capacity for active pharmaceutical ingredients and biologics. In the second quarter of , Merck reported worldwide of $15.8 billion, reflecting ongoing global efforts despite a 2% year-over-year decline, with full-year projections between $64.3 billion and $65.3 billion. The company's operations emphasize innovation in , vaccines, and infectious diseases, supported by a network of subsidiaries and partnerships worldwide.

Leadership and Executive History

Merck & Co. was established on January 1, 1891, by George Merck, a 23-year-old German immigrant and son of Emanuel Merck of the German firm, initially to distribute fine chemicals in . George Merck served as the company's first president until his death in 1926, overseeing early expansion into pharmaceuticals and the publication of the first Merck Manual in 1899. George W. Merck, son of the founder, joined the company in 1914, became vice president in 1918, and assumed the presidency in 1925 following his father's declining health. Under his leadership until 1950, Merck & Co. navigated challenges, including government seizure of assets in 1917 and collaboration on critical wartime projects like penicillin and production, while emphasizing research-driven innovation. George W. Merck died in 1957, after which subsequent presidents included figures like John T. Connor in the 1960s, who guided diversification into consumer products. From 1976 to 1985, John J. Horan served as president and CEO, focusing on internal growth amid regulatory pressures in the pharmaceutical industry. succeeded him as CEO from 1985 to 1994 (and chairman until 1995), a period marked by blockbuster drug developments such as Mevacor (the first ) and the Mectizan Donation Program for against river blindness, prioritizing R&D investment that elevated Merck's global stature. Raymond V. Gilmartin became president and CEO in June 1994 and chairman in November 1994, leading through acquisitions and product launches but resigning in April 2005 amid fallout from Vioxx safety concerns and litigation. Richard T. Clark then served as CEO from 2005 to 2011, stabilizing operations post-Vioxx withdrawal and merger with in 2009. Kenneth C. Frazier assumed the role of president and CEO in January 2011, becoming executive chairman in 2021 after 30 years at the company, during which he oversaw Keytruda's rise as a leading and the 2019 spin-off of the animal unit to . Robert M. Davis succeeded Frazier as CEO and president in July 2021 and chairman in December 2022, previously serving as executive vice president and , with a focus on expansion and partnerships like the 2023 deal for antibody-drug conjugates. As of October 2025, Davis continues to lead, emphasizing pipeline innovation amid patent cliffs.
CEO/PresidentTenureKey Notes
George Merck1891–1926Founder; established U.S. distribution.
George W. Merck1925–1950Wartime R&D leadership; research emphasis.
John J. Horan1976–1985Internal growth focus.
P. Roy Vagelos1985–1994Blockbuster drugs; donation programs.
Raymond V. Gilmartin1994–2005Acquisitions; Vioxx era resignation.
Richard T. Clark2005–2011Post-merger stabilization.
Kenneth C. Frazier2011–2021Keytruda success; spin-offs.
Robert M. Davis2021–presentOncology focus; strategic alliances.

Historical Development

German Roots and U.S. Establishment (1668–1917)

The origins of Merck trace back to 1668, when , a , acquired the Engel-Apotheke (Angel Pharmacy) in , , establishing the foundational enterprise that would evolve into the . This served as the core of the family's pharmaceutical activities for generations, initially focusing on and dispensing medicines in the traditional manner. In 1816, Heinrich Emanuel Merck assumed control of the pharmacy from his father, marking a pivotal shift toward industrial production. Under his leadership, the firm began isolating and commercializing active pharmaceutical ingredients, such as in 1827, quinine in 1837, and in 1862, thereby transitioning from retail dispensing to large-scale chemical manufacturing and export. By 1850, Emanuel Merck formalized the operation as a family partnership, E. Merck, emphasizing research-driven innovation in alkaloids and fine chemicals, which laid the groundwork for global expansion. The U.S. presence began in 1887 with a sales office in to distribute German Merck products, followed by the formal incorporation of Merck & Co. on January 1, 1891, under , grandson of Heinrich Emanuel Merck, then aged 23. Headquartered initially at 62 , the subsidiary imported and marketed fine chemicals, antiseptics, and pharmaceuticals, capitalizing on growing American demand. By 1900, operations expanded with a manufacturing facility in , producing items like and antitoxin, reducing reliance on imports and building domestic production capacity. World War I disrupted these ties when the United States entered the conflict in April 1917, leading to the seizure of German-owned assets under the Trading with the Enemy Act of October 6, 1917. The U.S. government expropriated Merck & Co., severing its legal and operational connections to the Darmstadt parent and transforming it into an independent American entity to ensure continuity of pharmaceutical supply amid wartime exigencies and anti-German measures. This separation, effective by late 1917, preserved the Rahway operations under American control, with George W. Merck retained as president to guide its autonomous development.

Independence and Expansion (1917–1950)

In October 1917, following the ' entry into , the Alien Property Custodian seized control of Merck & Co.'s shares owned by its German parent company, E. Merck of Darmstadt, due to wartime restrictions on assets. The U.S. government auctioned the company in 1919, after which George F. Merck, head of the American branch, partnered with investors including and to repurchase it for approximately $3 million in stock, severing all ties with the German entity and establishing Merck & Co. as an independent American firm. , who had joined the company in 1914 and risen to vice president by 1918, assumed the presidency in 1925 amid his father's declining health, guiding operations until 1950 with a focus on scientific research over mere chemical distribution. Under George W. Merck's leadership, the company expanded through strategic mergers and infrastructure investments, including the 1927 acquisition of Powers-Weightman-Rosengarten Inc., which bolstered manufacturing and early research capabilities in pharmaceuticals and fine chemicals. In 1933, Merck established its dedicated Merck Research Laboratories in , organized into divisions for pure research, therapeutic research, and applied research, marking a shift toward internal innovation in . This era saw key product advancements, such as the commercial synthesis of vitamin B1 (thiamine) in the 1940s, enabling scalable production to combat deficiencies like beriberi, and positioning Merck as a leader in nutritional therapeutics by the late 1930s. By 1940, these efforts had elevated Merck to one of the United States' premier pharmaceutical producers, with expanded facilities supporting organic synthesis and biological testing. During , Merck contributed significantly to Allied medical efforts, scaling up production of penicillin through submerged fermentation techniques using corn steep liquor, which addressed wartime shortages of the antibiotic discovered by in 1928. The company also supported the 1943 discovery of , the first effective treatment for , by Merck scientists including , and voluntarily relinquished patent rights to facilitate widespread access, contributing to a nearly 50% drop in U.S. mortality by 1950. innovations included the 1949 commercial synthesis of (branded as CORTONE) by chemist Lewis Sarett for treating , advancing hormone-based therapies. In 1950, Merck entered the animal health sector with sulfaquinoxaline (S.Q.), an anticoccidial drug for , diversifying beyond human pharmaceuticals and laying groundwork for future growth.

Post-War Growth and Innovation (1950–2000)

Following World War II, Merck & Co. experienced significant expansion through strategic mergers and intensified research efforts. In 1953, the company merged with Sharp & Dohme, Inc., which bolstered its research capabilities, manufacturing infrastructure, and international distribution networks, including facilities in West Point, Pennsylvania. This acquisition facilitated broader market access and supported post-war recovery in pharmaceutical production. By 1950, Merck's widespread distribution of streptomycin, an antibiotic originally discovered in 1943, contributed to a nearly 50% reduction in U.S. tuberculosis deaths, demonstrating the company's role in public health advancements. A major innovation came in 1955 with the launch of Diuril (chlorothiazide), the first orally effective thiazide diuretic for treating , establishing Merck as a pioneer in cardiovascular therapeutics. The 1960s and 1970s saw further vaccine developments under virologist , including the 1969 introduction of the M-M-R II vaccine combining , , and protections, and the 1977 approval of Pneumovax 23, the initial targeting 23 strains. These products underscored Merck's commitment to preventive amid rising infectious challenges. The 1980s marked a surge in blockbuster pharmaceuticals, driven by leadership under CEO from 1985. Vasotec (enalapril), launched in 1981 as an for and , became Merck's first product to generate over $1 billion in annual sales by 1988. In 1986, Mevacor () debuted as the first commercial for cholesterol management, following extensive lipid research. Subsequent launches included Zocor (simvastatin) in 1992, another exceeding $1 billion in sales, and Singulair () in 1998 for treatment after two decades of development. Acquisitions and partnerships fueled sustained growth into the 1990s. The 1993 purchase of Medco Containment Services for $6.6 billion integrated , enhancing cost control and market reach. In 1999, Vioxx (), a COX-2 inhibitor for pain, entered the market, contributing to record revenues of $32.71 billion and of $5.89 billion that year. Merck also initiated the Mectizan Donation Program in 1987, committing to provide indefinitely for river blindness eradication in developing regions, reflecting alongside commercial expansion. By 2000, these innovations had positioned Merck as a global leader in pharmaceuticals, with R&D investments yielding treatments for , infectious diseases, and chronic conditions.

Modern Era Challenges and Transformations (2001–2019)

In the early 2000s, Merck faced severe repercussions from the withdrawal of its blockbuster painkiller (Vioxx), approved by the FDA in May 1999 but voluntarily removed from the market on September 30, 2004, following the APPROVe trial that demonstrated an approximate doubling of the risk for serious cardiovascular events like heart attacks and compared to . The drug had generated over $2.5 billion in annual sales at its peak, but post-withdrawal, Merck confronted nearly 30,000 lawsuits alleging inadequate warnings about cardiovascular risks, culminating in a $4.85 billion settlement in November 2007 covering about 85% of claims without admitting liability. This crisis eroded investor confidence, with Merck's stock price dropping sharply, and prompted the resignation of CEO Raymond Gilmartin in May 2005 amid criticism over the company's handling of emerging safety data from trials like VIGOR in 2000. Compounding these issues were patent expirations on key products, including Zocor (simvastatin) in June 2006 and Fosamax (alendronate) in February 2008, which triggered rapid generic erosion and contributed to a revenue decline from $22.5 billion in 2004 to $19.7 billion in 2005. These "patent cliffs" exposed vulnerabilities in Merck's small-molecule portfolio, as generics captured up to 80-90% of market share within the first year post-expiry, forcing cost-cutting measures like workforce reductions and R&D reallocations amid broader industry pressures on productivity. Under interim leadership from Richard T. Clark starting in 2005, and his subsequent appointment as CEO, Merck prioritized pipeline diversification, but ongoing Vioxx-related Department of Justice probes—resolved in 2011 with a $950 million civil and criminal settlement—further strained finances and operations. A pivotal transformation occurred through the $41.1 billion merger with , announced on March 9, 2009, and completed on November 4, 2009, which combined annual revenues exceeding $46 billion and bolstered Merck's vaccines and biologics segments with assets like the (approved June 2006) and biologics such as Remicade. Structured as a reverse merger with Schering-Plough shareholders receiving $10.50 cash plus 0.5767 Merck shares per share, the deal required divestitures like Merck's 50% stake in animal health Merial for $4 billion to secure regulatory approval, enabling geographic and therapeutic expansion while addressing post-patent revenue gaps. Under CEO Kenneth C. Frazier, appointed in January 2011, Merck accelerated a shift toward immuno-oncology and biologics, exemplified by the FDA approval of (Keytruda) on September 4, 2014, for advanced , which evolved into a cornerstone product driving revenue growth to $40 billion by 2019 through expanded indications in and other solid tumors. This era also saw investments in treatments like Januvia (approved October 2006) and strategic R&D partnerships to mitigate small-molecule declines, though challenges persisted from generic pressures and litigation, with Merck settling additional Vioxx claims into the 2010s. By 2019, these adaptations positioned Merck for dominance, offsetting earlier setbacks through diversified innovation rather than reliance on legacy blockbusters.

Recent Strategic Shifts (2020–Present)

In June 2021, Merck completed the spin-off of its women's health business unit, including established brands and biosimilars, into the independent company Organon & Co., distributing shares to Merck shareholders via a special dividend. This divestiture streamlined operations, allowing Merck to concentrate resources on high-growth segments such as oncology therapeutics, vaccines, and animal health, while Organon assumed responsibility for mature product lines facing generic competition. Anticipating the 2028 expiration of key patents for its blockbuster Keytruda (), which generated $29.5 billion in 2024 revenue, Merck accelerated pipeline diversification through targeted acquisitions. In November 2021, it acquired for $11.5 billion, incorporating sotatercept (branded Winrevair upon FDA approval in March 2024) to address pulmonary arterial hypertension and expand beyond . The June 2023 acquisition of Biosciences for $10.8 billion added PRA023, a targeting inflammatory bowel diseases like and , bolstering Merck's offerings. Further deals included the October 2025 completion of the $10 billion acquisition of Verona Pharma, securing ensifentrine (Ohtuvayre) for , and the July 2025 purchase of SpringWorks Therapeutics for $3.4 billion to enhance assets. To mitigate revenue risks from the Keytruda "patent cliff," estimated to create a potential $20 billion annual shortfall, Merck initiated a multiyear cost-reduction program in July 2025, targeting $3 billion in annual savings by 2027 through workforce reductions of about 6,000 positions and optimization, with proceeds reinvested in , development, and for emerging products like subcutaneous Keytruda (FDA-approved September 2025). Complementing this, Merck pledged over $70 billion in U.S.-based capital investments starting in 2025, including a $3 billion pharmaceutical center in and expansions for production, aimed at enhancing and supporting commercialization. These measures reflect a shift toward sustainable growth via innovation in cardiovascular, respiratory, and autoimmune therapies, reducing reliance on dominance.

Business Segments and Products

Human Health Pharmaceuticals

Merck's human health pharmaceuticals portfolio consists of prescription medicines targeting , cardio-metabolic disorders, infectious diseases, , , and other areas, excluding vaccines and biologics focused on . These products include both small-molecule drugs and monoclonal antibodies, with a heavy emphasis on innovative therapies for chronic and life-threatening conditions. In 2024, the broader pharmaceutical segment, encompassing these products alongside vaccines, reported worldwide sales of $57.4 billion, reflecting 7% growth year-over-year (10% excluding foreign exchange impacts), driven primarily by offerings. The oncology franchise dominates, led by KEYTRUDA (pembrolizumab), a PD-1 inhibitor approved for treating various solid tumors and hematologic malignancies, including , non-small cell , head and neck , and rare indications such as Merkel cell carcinoma. KEYTRUDA generated $29.5 billion in global sales in 2024, an 18% increase from 2023 (22% excluding ), accounting for nearly half of Merck's and underscoring its role as the world's top-selling . Other oncology products include KOSELUGO (selumetinib) for neurofibromatosis type 1 (NF1), a rare genetic disorder, WELIREG (belzutifan), a HIF-2α inhibitor for von Hippel-Lindau disease-associated tumors, pheochromocytoma/paraganglioma (PPGL; approved May 2025), and advanced , and WINREVAIR (sotatercept-csrk), approved in March 2024 for pulmonary arterial hypertension by targeting the activin signaling pathway to improve exercise capacity. TEMODAR () remains available for , though its sales have declined post-patent expiration. In cardio-metabolic disorders, Merck offers therapies for and cardiovascular conditions, notably JANUVIA (sitagliptin) and JANUMET (), DPP-4 inhibitors for management that improve glycemic control. These generated lower sales in recent years due to generic competition following U.S. patent expiry in 2026, contributing to segment headwinds. Additional options include STEGLATRO (ertugliflozin), an for glycemic control, often combined in STEGLUJAN or SEGLUROMET. VERQUVO (), a soluble stimulator, addresses chronic with preserved . Infectious disease treatments form a key pillar, featuring antibiotics and antivirals such as ZERBAXA (ceftolozane/tazobactam) for complicated intra-abdominal and urinary tract infections, NOXAFIL (posaconazole) for invasive fungal infections, and PREVYMIS (letermovir) for cytomegalovirus prophylaxis in transplant patients. Hospital acute care products include BRIDION (sugammadex) for rapid reversal of neuromuscular blockade during surgery and CANCIDAS (caspofungin) for candidemia and aspergillosis. ZINPLAVA (bezlotoximab) reduces recurrent Clostridium difficile infection risk. These address unmet needs in antimicrobial resistance and post-transplant care, though many face biosimilar or generic pressures. Other areas include and , with EMEND (aprepitant/fosaprepitant) for , and BELSOMRA (suvorexant), an orexin receptor antagonist for . STROMECTOL (ivermectin) treats parasitic infections like . Merck continues to invest in expanding this portfolio through R&D, focusing on precision medicine and combination therapies to counter expirations, such as KEYTRUDA's core U.S. in 2028, while navigating pricing pressures and regulatory scrutiny.

Vaccines and Biologics


Merck's vaccines portfolio targets infectious diseases recommended for routine immunization by the Centers for Disease Control and Prevention, covering 10 serious conditions including , , , varicella, , and human papillomavirus (HPV) infections. The division's flagship products include GARDASIL®9, a recombinant approved by the U.S. (FDA) on December 10, 2014, for preventing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which are linked to approximately 90% of cervical cancers and other HPV-related precancers. PROQUAD®, licensed by the FDA on September 6, 2005, combines live attenuated viruses for , , , and varicella in a single dose for children aged 12 months to 12 years, demonstrating efficacy rates of 91% against varicella and up to 98% against mumps in clinical trials involving over 4,500 children. RotaTeq®, approved on February 3, 2006, is an oral preventing caused by serotypes G1, G2, G3, G4, and G9 in infants, administered as a three-dose series starting at 6-12 weeks of age. Global vaccines sales totaled $13.448 billion for the year ended December 31, 2024, a slight decline from $13.654 billion in 2023, with growth in international markets offsetting U.S. softness amid shifting schedules. GARDASIL 9 remains a key revenue driver, bolstered by expanded approvals such as in in January 2025 for broader age groups. Other products include VARIVAX® for varicella, PNEUMOVAX® 23 for pneumococcal disease in adults, M-M-R® II for , , and , and VAQTA® for . These vaccines undergo rigorous FDA , with post-licensure via systems like VAERS monitoring adverse events, though causality for rare reports requires epidemiological confirmation. Merck's biologics efforts extend to manufacturing capabilities for large-molecule therapies, including investments in facilities like the $1 billion Wilmington Biotech center opened in 2025 for commercial production of biologic drugs. While the vaccines segment focuses on prophylactic biologics, Merck supports biologic pharmaceuticals through upstream processes, though human health biologics like monoclonal antibodies fall under separate pharmaceutical reporting. Safety profiles for these products are supported by large-scale clinical data; for instance, GARDASIL 9 trials involving over 15,000 participants showed no significant imbalance in serious adverse events compared to controls. However, ongoing U.S. product liability lawsuits allege that Merck misrepresented GARDASIL's risks, claiming severe side effects like autoimmune disorders, with the first jury trial commencing in January 2025 despite limited causal evidence in peer-reviewed studies affirming the vaccine's net benefit in reducing HPV-associated cancers. Merck maintains that extensive safety data, including from global , confirm the vaccines' favorable risk-benefit ratio, with benefits in disease prevention far outweighing rare adverse events.

Animal Health Division

Merck Animal Health, a division of Merck & Co., Inc., develops, manufactures, and markets a broad range of veterinary pharmaceuticals, vaccines, and health management solutions for , companion animals, and aquaculture species worldwide. The division operates as a global leader in animal health, emphasizing in areas such as prevention, diagnostics, and productivity enhancement for food-producing animals, while also addressing welfare needs for pets. In , it generated $5.9 billion in sales, representing approximately 9% of Merck & Co.'s and reflecting a 4% year-over-year growth (8% excluding foreign exchange impacts). The division's origins trace back to Intervet, founded in 1949 in Boxmeer, Netherlands, by feed manufacturer Wim Hendrix, initially focusing on health products like sulfaquinoxaline, the first for chickens. Following Schering-Plough's acquisition of Intervet in 2007, the business integrated into Merck & Co. after the 2009 merger, adopting the Merck Animal Health name on June 29, 2011. This heritage underscores over 70 years of research-driven advancements in veterinary science, including vaccines for respiratory diseases in and parasiticides for companion animals. Key product portfolios include like Bravecto for and control in dogs and cats, such as Nobivac for canine and feline core diseases, and productivity tools for , including reproductive health solutions like Nuflor antibiotics. In , offerings expanded through the July 9, 2024, acquisition of Elanco's aqua business, adding and therapeutics for species to combat bacterial and parasitic infections. Other innovations encompass diagnostics and technologies, bolstered by the August 2020 acquisition of IdentiGEN for DNA-based animal identification systems. Strategic expansions include the April 2017 acquisition of Brazilian firm Vallée S.A. for veterinary biologics and the May 2025 announcement of an $895 million investment in , facilities for manufacturing and R&D to enhance production capacity. These efforts position the division amid growing demand for sustainable animal protein production and pet care, with 2023 sales reaching $5.6 billion and marking it as one of the sector's fastest-growing entities.

Research, Development, and Pipeline

R&D Investment and Strategy

Merck & Co. allocates substantial resources to , with non-GAAP expenses totaling $17.9 billion in 2024, down 40% from the prior year due to the absence of one-time costs, yet still representing 28% of the company's $64.2 billion . The 2023 figure of $30.5 billion included significant expenditures on acquisitions and partnerships expensed under pharmaceutical rules, more than doubling typical annual outlays and exceeding half of that year's . This investment supports a global network of scientists advancing therapies across key therapeutic areas. Merck's R&D strategy centers on converting cutting-edge science into approved medicines and , prioritizing unmet needs in , , infectious diseases, cardio-metabolic disorders, , , and ophthalmology. The approach integrates internal discovery with external collaborations, acquisitions, and advanced technologies such as AI-driven tools for hit-to-lead optimization, bioanalytical methods, and patient-centric formulation design to expedite pipeline progression. Emphasis is placed on immuno-oncology innovations, tumor targeting, and diversification beyond (Keytruda), including over 20 late-stage programs in diverse indications. To sustain growth amid patent expirations, Merck initiated a $3 billion cost-reduction program in 2025, targeting administrative, sales, and R&D efficiencies by 2027, with redirected funds bolstering pipeline candidates, manufacturing capabilities, and novel modalities like antibody-drug conjugates and . This reflects a causal focus on reallocating capital from mature assets to high-potential innovations, informed by data and competitive treatment landscapes, while maintaining rigorous diversity to enhance generalizability.

Key Pipeline Candidates and Innovations

Merck's research pipeline as of August 1, 2025, features over 80 programs, with a strong emphasis on , reflecting the company's strategy to extend beyond Keytruda through targeted therapies and combinations. Key innovations include antibody-drug conjugates (ADCs) with novel targets such as HER3, B7-H3, and CDH6, enabling precise delivery of cytotoxic payloads to tumor cells, and personalized mRNA-based neoantigen vaccines developed in partnership with . These approaches aim to address resistance mechanisms and expand into earlier disease stages and new tumor types. In oncology, Phase 3 candidates dominate, including patritumab deruxtecan (MK-1022), an investigational HER3-directed ADC in collaboration with Daiichi Sankyo, evaluated for breast cancer and other HER3-expressing tumors. Ifinatamab deruxtecan (MK-2400), another Daiichi Sankyo-partnered ADC targeting B7-H3, advances in Phase 3 for esophageal, prostate, and small cell lung cancers. Sacituzumab tirumotecan (MK-2870), licensed from Kelun-Biotech and targeting Trop-2, is in Phase 3 across multiple indications like breast, cervical, and ovarian cancers, often combined with pembrolizumab (Keytruda). Nemtabrutinib (MK-1026), a next-generation BTK inhibitor acquired from ArQule, targets hematologic malignancies in Phase 3, offering potential advantages over covalent BTK inhibitors in overcoming resistance mutations. Additionally, V940 (intismeran autogene, mRNA-4157), a personalized cancer vaccine co-developed with Moderna, is in Phase 3 for adjuvant melanoma and other solid tumors, leveraging tumor-specific neoantigens to elicit T-cell responses alongside Keytruda. Beyond , Merck's pipeline includes V181, a quadrivalent in Phase 3, representing an innovative prophylactic approach against a major global infectious disease threat. In , tulisokibart (MK-7240), a inhibiting TL1A, progresses in Phase 3 for and , targeting a pathway implicated in intestinal . These candidates underscore Merck's diversification into biologics with novel mechanisms, supported by acquisitions and partnerships that enhance therapeutic modalities like ADCs and mRNA technologies.
Therapeutic AreaCandidatePhaseKey Indication(s)Notable Innovation/Partnership
OncologyPatritumab deruxtecan (MK-1022)3HER3-targeted ADC; Daiichi Sankyo collab.
OncologySacituzumab tirumotecan (MK-2870)3Multiple (e.g., ovarian, NSCLC)Trop-2 ADC; Keytruda combos; Kelun-Biotech.
OncologyV940 (mRNA-4157)3, solid tumorsPersonalized mRNA neoantigen ; Moderna.
VaccinesV1813Quadrivalent vaccine platform.
ImmunologyTulisokibart (MK-7240)3IBD (Crohn's, UC)Anti-TL1A .

Manufacturing and Supply Chain Investments

Merck & Co. has pursued extensive investments in manufacturing infrastructure to expand production capacity for pharmaceuticals, biologics, and , while addressing vulnerabilities exposed by global disruptions such as the . These efforts emphasize domestic U.S. facilities to reduce reliance on international suppliers and enhance resilience against shortages. Since , Merck has committed over $12 billion to U.S. capital projects, with plans for an additional $9 billion by the end of the decade, including biologics and small-molecule capabilities. A cornerstone of these initiatives is the $3 billion for in , where construction began on October 19, 2025. This 400,000-square-foot facility will focus on small-molecule drug production and is projected to create 500 jobs, building on Merck's existing operations at the site to support growing demand for and other therapies. In parallel, Merck broke ground on a $1 billion biologics manufacturing center in , on April 29, 2025, as part of a broader $3.5 billion commitment to U.S. biologics and small-molecule sites. For vaccines, Merck completed a $1 billion expansion of its Durham, North Carolina, facility in March 2025, adding 225,000 square feet to boost production capacity for products like Gardasil. This project contributes to over $12 billion in cumulative U.S. investments since 2018 and aligns with efforts to secure vaccine supply chains amid fluctuating global demand. In the animal health sector, Merck allocated $895 million for expansions in De Soto, Kansas, announced on May 8, 2025, enhancing biologics manufacturing on an existing site to meet veterinary product needs. These manufacturing expansions underpin Merck's strategy by localizing critical production, minimizing geopolitical risks, and integrating advanced technologies for efficiency. The company's overarching $70 billion U.S. pledge, starting in 2025, excludes potential future acquisitions and prioritizes scalable facilities to support growth, though it has drawn scrutiny over long-term cost recovery amid patent expirations for blockbusters like Keytruda.

Acquisitions, Divestitures, and Growth Strategies

Major Acquisitions

In 2009, Merck & Co. merged with Corporation in a $41 billion transaction, the largest in its history at the time, which integrated Schering-Plough's portfolios in (including the combined Prevnar franchise), biologics like Remicade, and animal health, positioning the combined entity as the world's second-largest pharmaceutical company by revenue. The merger, completed on November 4, 2009, after regulatory approvals, also brought cholesterol drugs like Zetia and Vytorin, though subsequent expirations challenged long-term value. Subsequent acquisitions targeted pipeline enhancement in infectious diseases and hospital care. In December 2014, Merck acquired Cubist Pharmaceuticals for $102 per share in cash, equating to an $8.4 billion equity value plus $1.1 billion in assumed debt, to bolster anti-infectives with products like Zerbaxa (ceftolozane/tazobactam) for complicated infections; the deal closed in January 2015.
YearTarget CompanyDeal ValueStrategic Focus
2009$41 billionVaccines, biologics, animal health
2014Cubist Pharmaceuticals$8.4 billion (equity)Anti-infectives for hospital use
2021$11.5 billionRare diseases, oncology (e.g., sotatercept for )
2023 Biosciences$10.8 billionImmunology, (PRA023)
2025 Pharma~$10 billionRespiratory (ensifentrine for COPD)
Oncology and rare disease expansions accelerated post-2020. Merck's $11.5 billion acquisition of , announced in September 2021 and completed in November 2021, added sotatercept, a first-in-class activin signaling inhibitor approved in 2024 as Winrevair for pulmonary arterial hypertension, diversifying beyond Keytruda-dependent growth. In 2023, the $10.8 billion purchase of Biosciences, at $200 per share and closed in June 2023, secured PRA023 (now subcutaneousPRA023), a precision medicine for targeting TL1A, amid rising demand for assets. Recent deals emphasize cardio-pulmonary and respiratory innovation. In July 2025, Merck agreed to acquire Verona Pharma for $107 per American Depositary Share (representing eight ordinary shares), valuing the deal at approximately $10 billion and completing it in October 2025, to add Ohtuvayre (ensifentrine), a first-in-class inhaled PDE3/4 inhibitor for COPD maintenance therapy. As of January 2026, Merck is reportedly in talks to acquire Revolution Medicines, a Redwood City-based biotech focused on oncology with a market capitalization of nearly $19 billion, with discussions involving a price range of $28 billion to $32 billion, though no deal has been finalized and other potential buyers remain interested. These acquisitions reflect a pattern of high-value bets on late-stage or commercial-stage assets to offset Keytruda's impending patent cliff in 2028, with total deal values exceeding $80 billion since 2009.

Divestitures and Spin-Offs

In 2003, Merck & Co. spun off its pharmacy benefits management subsidiary, , Inc., as an independent publicly traded company to allow each entity to pursue distinct strategic priorities. The distribution occurred on August 19, 2003, with Merck shareholders receiving 0.1206 shares of Medco for each share of Merck held at the close of business on August 11, 2003. This separation enabled Medco to operate autonomously in the pharmacy benefits sector while Merck refocused on its core pharmaceutical activities. In 2014, Merck divested its consumer care business to for $14.2 billion, marking a strategic exit from over-the-counter products to concentrate on prescription pharmaceuticals and . The agreement, announced on May 6, 2014, included global trademarks and rights to brands such as Claritin (loratadine medication), Coppertone sunscreens, and foot care products. The transaction closed on October 1, 2014, following regulatory approvals, and generated approximately $9.5 billion in after-tax proceeds for Merck after accounting for taxes and transaction costs. Merck completed the spin-off of on June 2, 2021, distributing shares of the new entity to its shareholders as a special to sharpen focus on innovative medicines in , , and hospital care. encompassed Merck's portfolio (including contraceptives and fertility treatments), established prescription brands, and biosimilars business, which collectively generated about $4.4 billion in 2020 revenue. Shareholders received one share of Organon for every four shares of Merck held as of May 24, 2021, with Organon shares beginning trading on the under the ticker "OGN" on June 3, 2021. The move was intended to create two independent companies with dedicated operational agility, though Organon's reliance on mature products raised questions about its long-term growth prospects independent of Merck's R&D engine.

Strategic Partnerships and Collaborations

Merck & Co. has pursued strategic partnerships to bolster its and infectious disease pipelines, often involving co-development, licensing, and shared commercialization rights for novel therapies. These collaborations leverage external innovation to complement Merck's internal research, particularly around its blockbuster (Keytruda), while mitigating R&D risks through cost-sharing and milestone-based payments. A cornerstone partnership is with , initiated in June 2016 to develop personalized mRNA-based cancer vaccines encoding patient-specific neoantigens, combined with Keytruda for multiple cancer types. Merck provided Moderna an upfront payment of $250 million (including $200 million cash and a $50 million equity investment), with potential milestones exceeding $2.5 billion per product and tiered royalties. The agreement expanded in May 2018 to advance additional mRNA vaccines, and in April 2023, the companies extended co-development and co-commercialization of mRNA-4157/V940, sharing development costs and profits equally worldwide. By October 2024, they launched a Phase 3 trial evaluating adjuvant mRNA-4157/V940 plus Keytruda in high-risk patients post-surgery, following positive Phase 2b data showing a 44% reduction in recurrence or death risk. In , Merck collaborates with on antibody-drug conjugates (ADCs), highlighted in its second-quarter 2025 earnings as advancing multiple assets, including patritumab deruxtecan (MK-1022) for EGFR-mutated non-small cell in Phase 3 trials. This partnership, building on earlier alliances, focuses on DXd-based ADCs to target solid tumors, integrating with Keytruda combinations to enhance efficacy in resistant populations. Merck also formed a collaboration with Ridgeback Biotherapeutics in May 2020 for , an oral antiviral for , where Merck committed $1.2 billion in non-dilutive funding for development and commercialization rights outside certain regions; the received in the UK in November 2021 but was later withdrawn there in 2023 after a Phase 3 showed no significant mortality benefit. In December 2024, Merck invested $50 million in Personalis Inc. via to support genomic sequencing technologies aiding tumor profiling for personalized therapies, aligning with its precision strategy. Earlier vaccine collaborations, such as the Sanofi Pasteur MSD in , were terminated in 2021 to allow independent growth strategies after operating since 1994.

Financial Performance

Merck & Co.'s total worldwide sales reached $64.2 billion in , marking a 7% increase from $60.1 billion in 2023. The company's revenue is primarily derived from two segments: pharmaceutical products, which accounted for approximately 89% of total sales at $57.4 billion, and animal health products, contributing the remaining 11% at $5.9 billion. Pharmaceutical sales grew 7% year-over-year (10% excluding foreign exchange impacts), driven largely by therapies, while animal health sales increased 4% (8% excluding foreign exchange). Within pharmaceuticals, oncology products represent the dominant revenue source, comprising over half of the segment's sales. Keytruda (pembrolizumab), an anti-PD-1 immunotherapy for various cancers, generated $29.5 billion in 2024, up 18% from $25.0 billion in 2023, fueled by expanded indications and volume growth across multiple tumor types. This blockbuster drug alone accounted for nearly 46% of Merck's overall revenue, underscoring the company's heavy dependence on a single product amid patent protection until 2028. Vaccines, particularly Gardasil 9 for human papillomavirus prevention, contributed $8.6 billion in 2024, a decline from $8.9 billion in 2023, primarily due to reduced demand in China from local competition and inventory adjustments. Other pharmaceutical categories, including hospital acute care and diabetes treatments, provided smaller but stable contributions, though legacy products like Januvia have faced generic erosion. Animal health revenue stems from livestock and companion animal products, including vaccines, antimicrobials, and parasiticides, with sales bolstered by demand in poultry and pet segments. The segment's growth reflects global increases in animal protein consumption and pet ownership, though it remains sensitive to commodity prices and regulatory changes in livestock production. Geographically, about 50% of 2024 revenue originated from the , with international markets, including , , and emerging regions, supplying the balance; exposure, particularly via , has introduced volatility amid shifting local market dynamics. Overall trends indicate sustained expansion through innovation, tempered by headwinds and the need for diversification to mitigate impending Keytruda revenue cliffs post-patent expiry.

Profitability and Cost Management

Merck & Co. achieved a gross of 76.3% for the full year 2024, up from 73.2% in 2023, primarily attributable to a favorable product mix emphasizing high-margin drugs like Keytruda. This improvement reflected operational leverage from revenue growth outpacing increases, with worldwide sales reaching $64.2 billion, a 7% rise year-over-year. for 2024 totaled $17.1 billion, yielding a of approximately 26.6%, a substantial recovery from 2023's depressed $365 million , which was burdened by $16.8 billion in acquisition-related charges from the 2021 deal. Cost management contributed to profitability through disciplined expense control, particularly in research and development (R&D), where GAAP R&D expenditures declined 41% to $17.9 billion in 2024 from $30.5 billion in 2023, excluding the prior year's one-time integration costs. Selling, general, and administrative (SG&A) expenses remained stable at approximately $10.8 billion in 2024, flat relative to recent years amid efforts to streamline commercial operations. Operating consequently strengthened to $19.9 billion. In July 2025, Merck initiated a multi-year cost-reduction program targeting $3 billion in annual savings by 2027, involving the elimination of about 6,000 positions (roughly 8% of its global workforce) and operational efficiencies across non-core functions. These measures, framed as preparation for Keytruda's 2028 U.S. expiration, prioritize reinvestment into expansion and new product launches rather than debt reduction or dividends, signaling a shift toward sustaining margins amid anticipated pressures from competition. Non-GAAP gross margins further underscored efficiency gains, reaching 80.5% in Q3 2024 versus 77.0% in Q3 2023.

Market Valuation and Shareholder Returns

As of October 24, 2025, Merck & Co. (NYSE: MRK) maintains a of $223.58 billion, reflecting its position as one of the largest pharmaceutical companies by . The company's trailing twelve-month price-to-earnings (P/E) ratio is 13.79, while the forward P/E ratio is 9.13, suggesting investor expectations of earnings growth amid ongoing expirations and developments. Enterprise value stands at $250.36 billion, with an EV/EBITDA multiple of approximately 8.67 based on recent quarterly data, lower than historical five-year averages around 12-16, which may indicate relative undervaluation compared to operational cash flows but also vulnerability to revenue concentration risks from blockbuster drugs like Keytruda. Merck delivers returns primarily through and share repurchases, with a forward of 3.70% on an annualized basis of $3.24 per share, supported by 14 consecutive years of increases as of September 2025. The company repurchased $1.345 billion in shares during the first half of 2025, marking a 436% increase from prior periods, bolstered by a $10 billion repurchase announced on , 2025. Over the past decade through August 2025, Merck has returned $89 billion to via these mechanisms, contributing to a latest-twelve-month yield of 6.5%, combining and buyback yields. Stock price performance has been mixed, with total shareholder return (including dividends) at 36.42% over five years to October 2025, but a year-to-date decline of 9.52% and a trailing twelve-month drop of 14.31%, influenced by factors such as and broader market pressures on pharmaceuticals. The shares buyback ratio reached 1.28% as of October 19, 2025, aiding accretion despite revenue headwinds. These returns underscore Merck's commitment to capital allocation favoring income generation over aggressive growth investments, though sustainability depends on resolving pipeline gaps post-2028 patent cliffs.

Vioxx Safety and Marketing Scandal

Vioxx (), a selective COX-2 inhibitor developed by Merck & Co. for treating and acute pain, received U.S. (FDA) approval on May 20, 1999, based on clinical trials demonstrating efficacy comparable to traditional NSAIDs with reduced gastrointestinal side effects in short-term studies involving low-risk patients. The drug quickly became a blockbuster, generating peak annual sales exceeding $2.5 billion by 2003, driven by extensive and physician promotion emphasizing its gastrointestinal safety profile over competitors like naproxen. Early post-approval data raised cardiovascular concerns. The VIGOR (Vioxx Gastrointestinal Outcomes Research) trial, published in November 2000, compared Vioxx to naproxen in 8,076 patients and found a fivefold increase in myocardial infarctions and other thrombotic events (0.4% vs. 0.1% incidence) in the Vioxx group, alongside fewer gastrointestinal ulcers. Merck's internal analyses and public statements attributed this disparity to naproxen's purported cardioprotective effects rather than inherent Vioxx risks, a position contested by independent meta-analyses that later highlighted an absolute risk increase of about 1.9 events per 1,000 patients annually. Despite these signals, Merck continued aggressive marketing, including off-label promotion for prior to FDA approval for that indication, prompting an in September 2001 for misleading claims about cardiovascular safety. Internal Merck documents, revealed through litigation, indicated awareness of potential thrombotic risks as early as 1996 preclinical studies and post-approval , yet the company prioritized sales strategies that downplayed hazards. These included ghostwriting articles for medical journals to emphasize gastrointestinal benefits while selectively omitting cardiovascular data, and equipping sales representatives with materials claiming Vioxx was "eight to eleven times safer" than naproxen for heart —contradicting VIGOR findings. Merck also influenced key opinion leaders and funded studies like ADVANTAGE, which internal emails showed was designed to obscure s by comparing Vioxx unfavorably only in short durations. Cumulative evidence from pooled placebo-controlled trials by 2004 suggested a dose-dependent elevation, with relative increases of 1.9-fold for confirmed thrombotic . Accumulating data from long-term use prompted Merck's voluntary worldwide withdrawal of Vioxx on September 30, 2004, following interim results from the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial, which demonstrated a 1.92-fold increased of cardiovascular events (including and ) after 18 months of use compared to (23 events vs. 11 in 2,586 patients). The FDA's subsequent review affirmed the risks but criticized its own pre-withdrawal oversight, with internal whistleblowers testifying that agency scientists faced retaliation for advocating stronger warnings earlier. By withdrawal, an estimated 20 million patients had used Vioxx, with retrospective analyses linking it to tens of thousands of excess cardiovascular events, though Merck contested and liability. The scandal triggered extensive litigation, with over 27,000 claims alleging Merck concealed risks. In November 2007, Merck settled most for $4.85 billion, without admitting fault, covering heart attack and victims. Additional resolutions included a $950 million civil and criminal settlement in 2011 for unlawful promotion, including kickbacks to induce prescriptions, and $830 million in 2016 for related claims. Congressional investigations, including 2005 hearings, exposed Merck's data manipulation tactics, fueling debates on post-market surveillance and industry influence over regulatory science, with evidence from court-released emails underscoring causal links between suppressed risk data and delayed action.

Fosamax and Other Product Liability Cases

Fosamax (alendronate sodium), a bisphosphonate drug approved by the U.S. Food and Drug Administration on September 29, 1995, for the treatment and prevention of postmenopausal osteoporosis, faced extensive product liability litigation over claims of inadequate warnings regarding rare adverse effects from prolonged use, primarily osteonecrosis of the jaw (ONJ) and atypical subtrochanteric or diaphyseal femoral fractures. Plaintiffs argued that Merck failed to disclose these risks despite internal awareness and emerging post-marketing data linking bisphosphonates to suppressed bone remodeling, which could lead to pathological fractures or jaw bone death in susceptible patients. Merck maintained that the benefits of fracture prevention in osteoporosis patients outweighed these uncommon risks, supported by clinical trials showing net efficacy, and that FDA oversight precluded additional state-mandated warnings. ONJ-related suits, initiated around 2005 following dental surgery reports, resulted in over 1,200 U.S. claims consolidated for pretrial proceedings. Merck prevailed in five of seven trials, including a state defense verdict, before agreeing in December 2013 to a $27.7 million settlement resolving all pending ONJ cases without admitting liability; this represented an average payout of under $23,000 per claimant. fracture litigation, involving thousands of cases in Multidistrict Litigation No. 2243, centered on allegations of subtrochanteric fractures after years of therapy. In 2013, the U.S. District for the District of granted for Merck, preempting state failure-to-warn claims under federal law because the FDA had rejected the company's proposed label enhancements in 2009, deeming insufficient evidence of causation. The Third Circuit affirmed preemption in 2017, citing Merck's compliance with FDA's "changes-being-effected" process and the agency's determination that available data did not justify stronger warnings. The U.S. vacated this in Merck Sharp & Dohme Corp. v. Albrecht (May 20, 2019), ruling unanimously that a manufacturer's good-faith rejection by the FDA does not categorically preempt state duties if unilateral label changes were feasible under regulations, remanding for factual assessment of Merck's efforts. On remand, courts upheld preemption, finding Merck had submitted evidence-based proposals that FDA declined amid ongoing review of class risks; in September 2024, the Third Circuit affirmed dismissal of the consolidated cases, effectively ending major U.S. liability exposure. No large-scale settlements occurred for claims, distinguishing Fosamax from higher-stakes precedents. Beyond Fosamax, Merck has encountered product liability suits over other pharmaceuticals, though without comparable scale or payouts. For , the approved in 2006, over 140 cases allege concealment of risks like autoimmune disorders and , consolidated in MDL No. 3035; however, courts have frequently dismissed claims via preemption under the , with a 2025 federal ruling favoring Merck on safety disclosures. Suits involving Propecia ( for ) cite persistent , yielding individual settlements but no mass resolution, while Januvia (sitagliptin for ) faces scattered claims of and without significant aggregate judgments. These cases often hinge on FDA-approved labeling and post-approval surveillance, with Merck prevailing on causation or preemption defenses in most instances.

Regulatory Violations and Overbilling Allegations

In 2008, Merck agreed to pay more than $650 million to settle allegations that it violated the Drug Rebate Statute by failing to report accurate "best prices" for its drugs Zocor, Vioxx, and Pepcid to state programs, thereby underpaying required rebates and causing government overpayments. The company allegedly classified deep discounts provided to hospitals as "nominal prices," excluding them from rebate calculations, and also paid kickbacks to physicians—disguised as consulting or training fees—to induce prescriptions of its products. As part of the resolution, Merck entered a five-year Corporate Integrity Agreement with the Office of Inspector General but did not admit liability. In 2011, a former Merck subsidiary, , settled for $24 million over claims that it overpaid pharmacists for switching patients to a branded version of the Coumadin instead of generics, leading to inflated reimbursements from programs. Merck has also faced U.S. (FDA) enforcement for manufacturing and compliance violations. In 2008, the FDA issued a warning letter citing "significant objectionable conditions" at Merck's West Point, facility, including inadequate validation of manufacturing processes for vaccines and active pharmaceutical ingredients, deficiencies in , and failure to investigate deviations adequately. The agency required corrective actions to prevent adulterated products under the Federal Food, Drug, and Cosmetic Act. Separately, in 2012, the FDA warned Merck for failing to conduct and report required postmarketing studies on potential cancer risks associated with its Januvia and Janumet, rendering the products misbranded and subjecting the company to potential civil penalties up to $250,000 per violation. In 2015, Merck settled for $5.9 million to resolve Department of Justice claims that its acquired subsidiary Inspire Pharmaceuticals had promoted the eye antibiotic AzaSite for unapproved pediatric uses, violating FDA regulations on off-label marketing. The government alleged that sales representatives encouraged such uses to boost prescriptions, leading to improper Medicare and reimbursements.

Intellectual Property and Naming Disputes

Merck & Co., Inc. (the U.S.-based entity) and Merck KGaA (the German-based entity) trace their origins to the same family-owned firm founded in 1668, but diverged after when the U.S. was seized as enemy property and later operated independently as Merck & Co.. A 1955 coexistence agreement permitted Merck & Co. to use the "Merck" name exclusively in the United States and , while Merck KGaA retained rights elsewhere; internationally, Merck & Co. markets under the MSD (Merck Sharp & Dohme) brand to avoid confusion.. Despite this, digital globalization has sparked trademark disputes, as online presence can blur geographic boundaries and imply unified .. In January 2016, Merck & Co. filed a lawsuit in U.S. District Court in against Merck KGaA (operating as EMD Group in the U.S.), alleging improper use of the "Merck" name on U.S.-accessible websites and materials, which violated the coexistence terms by suggesting affiliation.. Merck KGaA countered with claims of its own rights, leading to ongoing proceedings; both parties acknowledge multiple legal actions across jurisdictions concerning name usage and trademarks.. In the , a 2020 High Court ruling found Merck & Co. infringed Merck KGaA's trademarks through "Merck"-branded websites and visible in the UK, interpreting such use as targeting non-exclusive territories.. This was upheld by the Court of Appeal in March 2025, dismissing Merck & Co.'s appeal and reinforcing that global digital platforms can constitute infringing use under local laws, even absent physical sales.. Beyond naming, Merck & Co. has engaged in significant patent disputes over pharmaceutical innovations. In a high-profile 2016 case, a federal jury ruled that infringed two Merck s on hepatitis C treatments, awarding Merck $2.54 billion in damages for Gilead's (Sovaldi); the verdict centered on Merck's priority in analog chemistry, though subsequent appeals and settlements reduced the payout.. In September 2022, a U.S. District Court upheld the validity of Merck's s on sitagliptin (Januvia), rejecting Viatris's invalidity challenges in infringement suits over generic versions.. More recently, in March 2025, Merck petitioned the U.S. Patent and Trademark Office to challenge seven Halozyme Therapeutics patents related to subcutaneous , amid Halozyme's April 2025 lawsuit alleging Merck's subcutaneous Keytruda () infringes its ENHANZE technology for faster administration.. These disputes highlight Merck's aggressive defense of IP for blockbuster products like Keytruda, which generated over $25 billion in 2023 revenue, against rivals seeking to enable biosimilars or alternative formulations.. Such litigations underscore the pharmaceutical industry's reliance on robust protection, with outcomes often turning on and enablement claims under U.S. law..

Recent Regulatory Challenges (e.g., IRA Negotiations)

In June 2023, Merck & Co. filed a lawsuit against the U.S. Department of Health and Human Services (HHS) challenging the constitutionality of the Medicare Drug Price Negotiation Program established under the Inflation Reduction Act (IRA) of 2022, arguing that the program constituted "extortion," violated the Fifth Amendment's Takings Clause, and compelled false statements by requiring manufacturers to affirm negotiated prices as "fair." The suit sought to exempt Merck's drugs from mandatory negotiations, which allow the Centers for Medicare & Medicaid Services (CMS) to set maximum prices for select high-spend Medicare Part D and Part B drugs after a certain period post-approval, with non-participation penalties including exclusion from Medicare and Medicaid. Courts have largely rejected similar constitutional challenges from other manufacturers, enabling the program to proceed, though Merck's case highlighted industry concerns over reduced R&D incentives due to shortened effective patent lifecycles. Merck's blockbuster cancer immunotherapy Keytruda (pembrolizumab) was not selected in the program's initial rounds for 2026 price applicability, which targeted 10 other drugs with negotiated reductions averaging 38-79% from list prices, yielding $6 billion in projected Medicare savings for that year. However, in 2025, Merck anticipated Keytruda's selection for in 2026, with any agreed maximum prices taking effect January 1, 2028, potentially leading to subsequent U.S. sales declines as the drug, which generated over $25 billion globally in 2024, faces pricing pressure amid ongoing label expansions. Similarly, Merck forecasted government price setting for its diabetes treatments Januvia (sitagliptin) and Janumet in 2026, exacerbating revenue headwinds from patent expirations and generic competition. An August 2025 adjustment to the IRA's , clarifying exclusions for drugs with designations in additional indications, enabled Merck to extend Keytruda's eligibility for higher in Medicare for certain rare cancer uses, potentially preserving revenue before broader negotiations. Merck has publicly stated that the IRA's framework, by imposing after 9 years for small molecules and 13 years for biologics, discourages in high-risk , though proponents cite empirical savings and no immediate evidence of stalled pipelines as of 2025. These negotiations represent a shift toward government-mediated , contrasting with prior reliance on market dynamics and protections, with Merck projecting multiyear impacts on profitability absent further legislative changes.

Government Relations and Political Influence

Lobbying and Policy Advocacy

Merck & Co. maintains a substantial presence in the United States, focusing on federal that impact pharmaceutical innovation, rights, drug pricing mechanisms, and logistics. The company employs both in-house lobbyists and external firms to engage with , executive agencies, and regulatory bodies, often aligning efforts with industry groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA). Annual lobbying expenditures have consistently exceeded $8 million in recent years, reflecting intensified amid legislative threats to protections and pricing autonomy. In , Merck spent $9.19 million on , up from $8.3 million in 2022 but down slightly from a peak of $10.18 million in 2023; through mid-2025, expenditures reached $7.58 million. These funds supported on over 50 distinct issues in 2023 alone, including healthcare reform, trade policy, and research funding. A core advocacy priority is safeguarding , with Merck opposing measures perceived to erode patent exclusivity, such as compulsory licensing or accelerated generic entry, which the company contends disincentivize R&D investments exceeding $10 billion annually. In 2023, Merck initiated legal challenges against the Reduction Act's Medicare drug price negotiation provisions, asserting they constitute an unconstitutional taking of patented innovations by forcing sales at government-dictated prices below market value, potentially reducing future . Merck also lobbies against import tariffs and trade barriers that disrupt pharmaceutical supply chains, including Section 232 investigations into steel and aluminum duties affecting manufacturing inputs. On vaccines and , the firm advocates for policies enhancing access and funding, such as through partnerships for patented antivirals like during the , while resisting mandates or pricing caps that could limit profitability. Recent efforts include hiring firms like Ballard Spahr to counter potential expansions under the Trump administration, emphasizing equitable international pricing disparities without endorsing domestic gouging. Critics, including policy analysts, argue that such perpetuates high U.S. prices by prioritizing profits over affordability, though Merck counters that robust patents are essential for recouping the causal risks of failures, where over 90% of candidates fail clinical trials. The company's positions are informed by empirical data on R&D costs but face scrutiny for alignment with broader industry spending, which hit record levels in 2025 amid disputes over policies and price reforms.

Political Contributions and Affiliations

Merck & Co. operates the Merck PAC, a qualified multicandidate that collects voluntary contributions from eligible employees and corporate funds to support candidates for federal, state, and local offices across both major U.S. political parties. The PAC's activities align with the company's interests in pharmaceutical , including drug pricing, protections, and regulatory frameworks, distributing funds to incumbents and challengers deemed supportive of industry priorities regardless of party. In the 2023-2024 federal election cycle, the Merck PAC disbursed $542,500 directly to federal candidates, with additional contributions to party committees such as $125,000 to GOPAC (a Republican leadership PAC) and $45,788 to the . This cycle's allocations showed a slight Republican tilt, with $256,053 to Republican candidates and $226,892 to Democrats among top recipients, reflecting a pattern of bipartisan engagement to maintain access amid . Earlier cycles demonstrated similar pragmatism; for 2019-2020, the PAC contributed $490,000 to federal candidates, with 37.35% directed to Democrats and 62.45% to Republicans, prioritizing committee leaders in health-related oversight roles like the Energy and Commerce Committee. At the state level, Merck's 2023 corporate and PAC disclosures reveal targeted giving, such as $5,000 to the Alabama Majority PAC (Republican) and $3,500 to Alabama Works PAC (bipartisan but Democrat-leaning), alongside donations to Democratic state house candidates in and , totaling over $1 million in combined federal and state support. Merck's political strategy lacks overt partisan affiliation, instead emphasizing balanced contributions to hedge against policy shifts, as evidenced by maximum allowable donations to select Democratic and Republican congressional candidates in 2024. The company participates in industry groups like the Pharmaceutical Research and Manufacturers of America (PhRMA), whose separate PAC benefits from member support but operates independently of Merck's direct efforts. Executive-level personal affiliations remain limited in , with employee-driven PAC funding underscoring a decentralized approach over top-down . This model has sustained Merck's influence without aligning exclusively to one party, adapting to electoral outcomes that affect FDA approvals and Medicare negotiations.

Tax Strategies and Disputes

Merck & Co. has employed various tax planning strategies, including the allocation of rights to subsidiaries in low-tax jurisdictions such as , to minimize its global effective tax rate. For instance, in 2022, the company reported $1.85 billion in pretax income in the United States, representing less than 15% of its total pretax income, despite substantial U.S. sales of products like Keytruda, with profits largely booked offshore through intercompany arrangements. These practices, common in the , involve mechanisms where royalties for drug patents are paid to foreign affiliates, reducing in high-tax countries like the U.S. Critics, including U.S. Democrats, have described such structures as aggressive , estimating Merck shifted billions in Keytruda profits to , though the company maintains compliance with all applicable tax laws and alignment of tax outcomes with underlying business activities. Significant disputes arose in the early 2000s over and reallocation. The IRS challenged Merck's arrangements with foreign subsidiaries, particularly involving royalty payments from entities like Merck Sharp & Dohme Quimica (MSDQ) in , contending that should be reallocated to the U.S. parent for tax years 1989, 1991, and 1993-2001. In 2007, Merck settled multiple IRS disputes covering tax years 1993-2006, agreeing to pay $2.3 billion in es, interest, and penalties, resolving claims that had escalated to potential liabilities exceeding $5 billion including contingencies in . This settlement followed prolonged litigation, including U.S. Claims rulings rejecting certain IRS reallocations of royalty . Further litigation in the centered on Subpart F inclusions under U.S. rules for controlled foreign corporations. In a case involving years 1989, 1991, and 1993, the IRS assessed a $472.8 million deficiency after auditing for , which Merck contested seeking a $473 million refund. The U.S. Court of Appeals for the Third Circuit upheld the IRS position in , affirming approximately $500 million in Subpart F liabilities related to undistributed earnings of foreign subsidiaries, denying Merck's refund claim. By 2012, Merck held $53.4 billion in accumulated offshore earnings, reflecting ongoing reliance on such structures amid criticisms of stashing profits in tax havens. In recent years, political has intensified without formal IRS disputes, focusing on extensions of provisions like Section 199 deductions. In 2025, U.S. lawmakers accused Merck and peers of exploiting loopholes to route profits through subsidiaries in Ireland and , avoiding federal on billions in annual income from U.S. patient sales, though no new settlements or court rulings have emerged as of October 2025. Merck's effective has remained low relative to revenues—around 15-20% in recent filings—attributable to these international strategies, which the company defends as legal and essential for funding R&D in a competitive global market.

Corporate Social Responsibility

Philanthropic and Access Initiatives

Merck's philanthropic efforts are primarily channeled through the Merck Foundation, which has donated over $1 billion since its inception to support , , and community development programs. The foundation focuses on addressing barriers to health care access, particularly for underserved populations, through grants, product donations, and partnerships aimed at reducing disparities in diseases like , cancer, and infectious conditions. These activities complement corporate programs such as employee volunteerism and matching gifts, which encourage staff involvement in local and international causes. A cornerstone of Merck's access initiatives is the Mectizan Donation Program, launched in 1987 to provide (Mectizan) free of charge for treating (river blindness) and, since 2000, in endemic regions. By June 2025, the program had facilitated the donation of 5 billion treatments across 33 countries, contributing to the elimination of transmission in , , , , and several African nations. Independent analyses confirm the program's efficacy, noting its role in preventing blindness and at a cost-effective scale through partnerships with organizations like the and local health ministries. Merck bears the full cost of production, distribution logistics, and monitoring, estimated at tens of millions annually. In vaccine access, Merck has committed to supplying its HPV vaccine, , to low- and middle-income countries via collaborations with , the Vaccine Alliance, and , starting in 2017. This includes tiered pricing and supply agreements to support prevention programs, with over 100 million doses allocated by 2024 for Gavi-eligible nations. Additional efforts target HIV care equity through programs like HIV Care Connect, which provides resources and medications to improve treatment adherence in high-burden communities. Domestically, the Merck Patient Assistance Program offers free medicines and adult to uninsured or underinsured U.S. patients meeting income criteria, distributing millions of prescriptions annually, with patient-focused support available at https://www.merckhelps.com/.[](https://www.merck.com/patients/patient-support-programs/) The Merck Access Program supports healthcare professionals with patient access to medications, including benefits investigations, insurance coverage, co-pay assistance, prior authorizations, appeals, and referrals to the Patient Assistance Program, via https://www.merckaccessprogram.com/.[](https://www.merckaccessprogram.com/) MerckConnect provides a portal for healthcare professionals to access product information, request samples and coupons, and product-specific access details at https://www.merckconnect.com/.[](https://www.merckconnect.com/) Merck also supports global product donations for disaster relief and disease outbreaks, partnering with NGOs like Catholic Medical Mission Board to deliver supplies to remote areas since 1998. These initiatives are evaluated by external bodies, such as the Access to Medicine Index, which in 2023 rated Merck's strategies for expanding product registration and pricing in low-income markets as moderately comprehensive but noted room for broader application beyond sites.

Environmental and Ethical Practices

Merck & Co. has committed to achieving net-zero across Scopes 1, 2, and 3 by 2045, with interim targets including a 46% reduction in Scope 1 and 2 emissions by 2030 from a 2019 baseline and a 30% reduction in Scope 3 emissions by the same year. In 2023, the company reported a 12% reduction below the 2019 baseline for Scope 1 and 2 emissions and a 4% reduction for Scope 3, amid total emissions of 7,086,700 metric tons of CO₂ equivalent. These goals align with the , though progress relies on self-reported data and operational changes such as energy efficiency and supplier engagement. The company maintains water withdrawal at or below 23 million cubic meters annually, based on a 2015 baseline, achieving 19.4 million cubic meters in 2023—a 16% reduction—and recovering or reusing 1.5 million cubic meters. For , Merck aims to limit disposal to landfills or without to 20% or less by 2025, reaching 15% of total waste in 2023 across 74,320 metric tons generated, with 80% of beneficially reused. However, inherently produces significant waste, and the company faced a $1.5 million U.S. Environmental Protection Agency penalty in 2011 for violations including improper handling and discharges at its facilities. Merck operates under a and Ethical Operating Standards Handbook that mandate compliance with laws, , and , with mandatory training for employees and mechanisms for reporting violations. These frameworks emphasize in business dealings, including anti-bribery provisions and oversight via a Code of Conduct. In , Merck conducts for and safety, adhering to policies for ethical treatment, including welfare standards and minimization of animal use where alternatives exist. The company has faced , including a 2013 lawsuit by People for the Ethical Treatment of Animals alleging inadequate veterinary care and mishandling of animals at a contractor facility, though the case highlighted ongoing debates over testing necessity in pharmaceuticals. Merck reports compliance with regulatory requirements but acknowledges the ethical tensions in balancing scientific advancement with .

Criticisms of CSR Claims

Shareholders representing institutions affiliated with the Interfaith Center on Corporate Responsibility (ICCR) criticized Merck's 2023 lawsuit challenging the Inflation Reduction Act's provisions for Medicare drug price negotiations, arguing it contradicted the company's stated commitments to patient access and affordability outlined in its Access to Health Principles. The lawsuit targeted negotiations for high-cost drugs like Keytruda and Januvia, which had generated $17 billion in Medicare spending since 2017 and affected nearly 1 million patients, with critics such as Asset Management's Lauren Compere stating that the action demonstrated Merck's willingness "to protect profits even if it comes at the expense of patients." ICCR's Meg Jones Monteiro further contended that blocking affordability measures undermines long-term value creation, as unaffordable drugs limit . Analyses of Merck's philanthropic efforts, such as the Mectizan Donation Program for river blindness, have questioned whether CSR initiatives primarily serve reputational and market expansion goals rather than unalloyed benefits, with high costs—including $826 million in 2006 philanthropic contributions—and complex monitoring via 36 key performance indicators complicating transparent outcomes assessment. Critics argue these programs align with business interests, potentially prioritizing over societal impact, as evidenced by challenges in communicating program efficacy to stakeholders. The 2004 Vioxx withdrawal amplified skepticism toward Merck's ethical claims, with evidence of cardiovascular risks emerging by 2000 yet the drug remaining on the market until a 2004 confirmed heightened heart attack and risks, leading to over 27,000 lawsuits and a narrative of profit prioritization over safety that eroded trust in the company's responsibility assertions. case studies describe widespread criticism that Merck's mission to "put patients first" was undermined by decisions favoring revenue from the blockbuster painkiller, which peaked at $2.5 billion in annual sales before recall. Such historical events have been cited to question the authenticity of CSR frameworks, suggesting they may mask operational incentives conflicting with imperatives.

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