Mylan — BrandWiki

Mylan

defunct	November 16, 2020

fate	Merged with Upjohn to form Viatris

successor	Viatris

hq location city	Hatfield, Hertfordshire

hq location country	United Kingdom

products	Generic and specialty pharmaceuticals and active pharmaceutical ingredients

divisions	see Operations

footnotes	‡R1R‡

Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris.[2] Previously, the company was domiciled in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK[3] and a "Global Center" in Canonsburg, Pennsylvania, US.

In 2007, the company acquired a controlling interest in India-based Matrix Laboratories Limited, a top producer of active pharmaceutical ingredients (APIs) for generic drugs,[4] and the generics business of Germany-based Merck KGaA.[5] Through these acquisitions, the company grew from the third-largest generic and specialty pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.[6]

Mylan went public on the OTC market in February 1973.[7] It was listed on the NASDAQ,[8] and its shares were a component of the NASDAQ Biotechnology[9] and the S&P 500 indices.[10]

The company was founded in 1961 and developed and produced medicines for a wide range of medical disciplines, including oncology, anaphylaxis, antiretrovirals, cardiovascular, respiratory, dermatology, immunology, anesthesia and pain management, infectious disease, gastroenterology, diabetology/endocrinology, and women's healthcare.[11]

Corporate headquarters

Founded in 1961, the company was located in an abandoned skating rink in White Sulphur Springs, West Virginia.[12][13] The facility was moved to Pennsauken, New Jersey in 1962,[14] to Princeton, West Virginia in 1963, and then Morgantown, West Virginia, in 1965, and in 1976 it relocated its corporate headquarters to the Pittsburgh suburb Canonsburg, Pennsylvania. Finally in 2004 it moved to a new office center in nearby Southpointe, a suburban business park located in the Pittsburgh suburb of Cecil Township.[15]

Stock

On February 23, 1973, Mylan had its initial public offering (IPO),[16] when it became a publicly traded company on the OTC market under the ticker symbol MYLN. In 1976 the stock moved to the National Association of Securities Dealers Automated Quotations (NASDAQ). Their final stock move was in 1986, when their stock became available for trade on the New York Stock Exchange under the ticker symbol MYL. Prior to the Viatris combination, the stock was traded on the NASDAQ.

History

Founding to 1980

Mylan Pharmaceuticals was founded as a drug distributor in 1961 by Milan Puskar and Don Panoz.[12] In 1966, the company began manufacturing penicillin G tablets as well as vitamins and other dietary supplements.[12]

Panoz left the company in 1969 and Puskar quit the company in 1973, as it grew and experienced financial difficulties. The board hired Roy McKnight as board chairman, who convinced Puskar to return in 1976.

The company discontinued operating as a contract manufacturing organization in 1980 and instead chose to market their products under their own "Mylan-labeled" brand.[17]

1980s

Criticism

EpiPen pricing

Mylan acquired the right to market and distribute the EpiPen line of epinephrine autoinjector devices from Merck KGaA as part of their 2007 deal;[90] that right had formerly been held by Dey LP, a wholly owned subsidiary of Merck.[91] According to Bloomberg News, the devices deliver about $1 worth of drug.[92] At that time annual sales were around $200 million.[92] Bresch, the company's CEO, saw an opportunity to increase sales through marketing and advocacy, and the company launched a marketing campaign to increase awareness of the dangers of anaphylaxis for people with severe allergies that made the brand "EpiPen" as identified with its product as "Kleenex" is with facial tissue. The company also successfully lobbied the FDA to broaden the label to include risk of anaphylaxis and in parallel, successfully lobbied Congress to generate legislation making EpiPens available in schools and in public places like

Products

Generic Medicines

Branded Medicines

Management

Heather Bresch was an executive director and the CEO of Mylan from 2012 until the Viatris combination in 2020.[129] Robert Coury was chairman,[130] and Rajiv Malik was president.[131]

External links

References

FORM 10-K^
Paul J. Gough. After nearly 60 years, Mylan makes way for Viatris Pittsburgh Business Times, 16 November 2020, retrieved 10 December 2020^
10-K www.sec.gov, retrieved 2025-12-24

Dyazide & Maxzide

In the 1980s one of the most prescribed drugs in the US was Dyazide, a diuretic that was a combination drug containing triamterene and hydrochlorothiazide; it had been on the market since 1965 and its patents had expired in 1980.[19] Complications arose with the introductions of generics versions, because the formulation of Dyazide resulted in variable batches that made it impossible for generic manufacturers to show that their versions were bioequivalent.[20][21]

Some generic companies committed fraud trying to bring a generic version of Dyazide. Bolar Pharmaceutical had the first generic version approved in 1987, but it turned out that Bolar had fraudulently substituted Dyazide for its own version to conduct studies that were submitted to the FDA. By 1989 the FDA rescinded its approval based on its suspicions and filed criminal charges against Bolar, to which Bolar eventually pled guilty in 1991.[22][23]

The company chose to develop a new version of a triamterene/hydrochlorothiazide combination drug instead of going the generic route; it developed a different, more stable formulation[21] and used different dosages of each active ingredient (50 mg hydrochlorothiazide and 75 mg triamterene, compared with Dyazide's 25 mg hydrochlorothiazide and 50 mg triamterene). This drug had to get approval as a new drug, as opposed to a generic. Their product was called Maxzide and was approved in 1984.[24][25] The higher dose allowed once per day dosing, which the company and its marketing partner, Lederle, believed would help it compete against Dyazide, which had $210M in sales in 1983.[24] However, the company's patents on the drug were declared invalid in court, and its marketing exclusivity expired in 1987, prompting a rush of generic competition.[26]

The company had concerns about the practices of its competitors and the FDA in general, and also with regard to companies seeking to bring generic versions of Maxzide. The company hired private investigators to examine its competitors' practices, and when it found evidence of corruption, it submitted it to the House Oversight and Investigations Committee, which investigated and found fraud and corruption within the Food and Drug Administration's generic drugs division and at other generic companies.[27] Two of the companies that had gotten approval to market generic versions of Maxzide, Vitarine Pharmaceutical and Par Pharmaceutical, were targets of the company's initial investigation and were found to have used Maxzide to obtain their bioequivalence data, leading both companies to withdraw its generic competitor to Mylan's product.[27][28]

The corruption in the nascent generics industry and at the office in the FDA regulating it was widely covered in the media, and led to widespread concern among doctors and the public in the late 1980s and early 1990s that generic drugs were not really the same as the branded drugs they were meant to replace.[29][30][20]

Acquisitions begin

In 1987, the company entered into a joint venture with Bolar to buy Somerset Pharmaceuticals; Mylan wanted access to Somersets' drug discovery capabilities as well as its new drug for Parkinson's, selegiline; the deal was completed in 1988 but its consummation was dependent on FDA approval of selegiline, which came in 1989.[27][31][32]

Dyazide & Maxzide

2010s

Generic Advair agreement

In 2011, the company entered into an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize Pfizer's generic equivalent to GlaxoSmithKline's Advair (US)/Seretide (UK) Diskus incorporating Pfizer's proprietary dry powder inhaler delivery platform.[54] The company launched the product in the UK in 2015[55] and in February 2016 the FDA accepted its ANDA, putting it in line behind Hikma and Sandoz to launch a generic version in the US.[56]

EpiPen4Schools launch

In 2012, the company launched a program called EpiPen4Schools to sell EpiPens in bulk and with discounts to schools. To participate in the program schools had to agree not to buy epinephrine autoinjectors from any other company for a year, a requirement which a company spokesperson said is no longer part of its program.[57]

In December 2012, the National Association of State Boards of Education launched a policy initiative designed to "help state boards of education as they develop student health policies regarding anaphylaxis and epinephrine auto-injector access and use," and advocated for state laws protecting schools from legal liability for stocking and using epinephrine autoinjectors. Gayle Manchin, the mother of the company's CEO, Heather Bresch, had become president of the association in 2010, and shortly after had discussed donations from her "daughter's company" to the association. Manchin had been appointed to the West Virginia state school board by her husband, then-governor of the state Joe Manchin, in 2007. In a statement, the company said, "There is no truth to the suggestion that the company's efforts were anything but straightforward or that we are aware of anyone advocating inappropriately for the right of schoolchildren to have access to potential life-saving medicine."[58]

After successful lobbying from the company, in 2013, the "School Access to Emergency Epinephrine Act" became law after passing Congress with broad and bipartisan support; it protected anyone from liability if they administered epinephrine to a child in a school (previously, only trained professionals or the affected person were allowed to administer the drug, and were open to liability), and it provided some financial incentives for schools that didn't already stock epinephrine autoinjector to start stocking them.[59] Joe Manchin, the father of Mylan's CEO, was a senator at that time.[58]

Agila acquisition

Mylan executives lobbied for the Generic Drug User Fee Amendments of 2012 to have generic drug manufacturers fund increased FDA investigations of offshore manufacturing plants. The following year, it purchased Agila Specialties Private, an Indian company specializing in generic injectable drugs, for $1.6 billion.[60] When three Mylan plants, two of which were acquired from Agila, were censured over the following two years due to contamination issues, the Agila acquisition was criticized as corrupting Mylan's prior commitment to quality control.[61][62]

Abbott acquisition

In February 2015, in a tax inversion, the company acquired the generic drugs business in developed markets of Abbott Laboratories for $5.3 billion in stock.[63][64]

Also in February 2015, the company acquired Mumbai-based Famy Care and expand its presence in the market for women's contraceptives at about $750 million.[65][66]

Attempted Perrigo acquisition

In April 2015, the company attempted a hostile takeover of Perrigo, offering to buy $26 billion in shares directly from shareholders. Too few shareholders agreed to sell their stock by the deadline set in November 2015 and the effort failed.[67][68][69]

Attempted purchase by Teva

Two weeks after the company made its first offer for Perrigo, Teva Pharmaceuticals offered to buy the company for $40 billion; the combined companies would have been the world's largest generic company and the 9th biggest drug company in the world.[70] In July, Teva dropped its bid for Mylan and instead acquired Allergan's generic drug business for about the same price.[71][72]

New COPD drug

In June 2015, the company agreed to work with Pulmatrix, a company with a proprietary inhaled drug delivery platform, to co-develop a product to treat for chronic obstructive pulmonary disease (COPD); the product was PUR0200, a generic drug in a Pulmatrix device.[73]

Meda acquisition

In February 2016, the company announced it would acquire Meda AB for $9.9 billion.[74] In May 2016, the company announced it would acquire Renaissance Acquisition Holdings dermatology division for up to $1 billion.[75]

In December 2016, the State attorneys general of 20 states filed a civil complaint accusing the company of a coordinated scheme to artificially maintain high prices for a generic antibiotic and diabetes drug. The complaint alleged price collusion schemes between six pharmaceutical firms including informal gatherings, telephone calls, and text messages.[76]

In October 2017, the company announced the launch of the first FDA-approved generic of Teva's long-acting Copaxone. Approximately three months later, Credit Suisse analyst Vamil Divan cited IMS Health data which showed that the new generic accounted for 10% of the market.[77]

In May 2018, the company announced a collaboration with West Virginia University to provide children across West Virginia with

Valsartan recall

In 2018, valsartan manufactured by the company was voluntarily recalled due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) which is a probable human carcinogen.[79]

Generic Advair approval

In January 2019, the FDA announced its approval of the company's Wixela Inhub, the first approved generic version of GlaxoSmithKline's Advair Diskus.[80]

Merger with Pfizer's off-patent drug business and name change to Viatris

In late July 2019, the company and Pfizer announced that Pfizer would spin off and merge its off-patent medicine division, Upjohn, with Mylan.[81][82]

In November 2019, Mylan & Upjohn announced that the name of the new company would be Viatris.[83][84] The company continued sales of Mylan's more than 7,500 products, including biosimilars, generics, brand and over-the-counter remedies, with brands including the Epi-Pen, Viagra, Lipitor and Celebrex.[85][86]

founders
trade name	Mylan N.V.
former name	Milan
type	Public (under Dutch law)
industry	Pharmaceuticals
founded	1961 in White Sulphur Springs, West Virginia, United States

Corporate headquarters

Stock

History

Founding to 1980

1980s

Criticism

EpiPen pricing

Products

Generic Medicines

Branded Medicines

Management

External links

References

Dyazide & Maxzide

Acquisitions begin

Dyazide & Maxzide

Acquisitions begin

1990s

2000s

Attempted King Pharmaceuticals acquisition

Matrix acquisition

EpiPen acquisition

Attempted King Pharmaceuticals acquisition

Matrix acquisition

EpiPen acquisition

2010s

Generic Advair agreement

EpiPen4Schools launch

Agila acquisition

Abbott acquisition

Attempted Perrigo acquisition

Attempted purchase by Teva

New COPD drug

Meda acquisition

Valsartan recall

Generic Advair approval

Merger with Pfizer's off-patent drug business and name change to Viatris

Generic Advair agreement

EpiPen4Schools launch

Agila acquisition

Abbott acquisition

Attempted Perrigo acquisition

Attempted purchase by Teva

New COPD drug

Meda acquisition

Valsartan recall

Generic Advair approval

Merger with Pfizer's off-patent drug business and name change to Viatris

Stock

Acquisition history

Executive pay

Execution drugs