Founding to 1980 Mylan Pharmaceuticals was founded as a drug distributor in 1961 by
Milan Puskar and
Don Panoz.
1980s With the passage of the
Hatch-Waxman Act in 1984, the company and other small generic companies gained value; in the eighteen months following passage of the law the company's earnings grew 166% to $12.5 million and its stock value rose 800%.
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. 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. 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 By 1989 the FDA rescinded its approval based on its suspicions and filed criminal charges against Bolar, to which Bolar eventually pled guilty in 1991. 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 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. 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. 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. 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.
1990s The company acquired Bertek Inc. in 1993 for its
transdermal patch technologies, and kept it as a subsidiary. In 1999, the company renamed Bertek as Mylan Technologies Inc. (MTI). MTI eventually came to be the contract manufacturer for the
selegiline transdermal patch and was the first company to market generic nitroglycerin, estradiol, clonidine, and fentanyl transdermal patches. Before the round of price increases the price of generic drugs had been 5 - 10% of the price of branded drugs and afterwards it was around 50%.
2000s Attempted King Pharmaceuticals acquisition In 2004, the company and
King Pharmaceuticals began discussing a deal in which Mylan would acquire King for $4 billion; Mylan wanted to expand its presence in branded pharmaceuticals and to acquire King's sales force. The deal was complicated by a number of factors, and included an SEC investigation into King's accounting and
Carl Icahn obtaining a 9.8% interest in Mylan and becoming its largest stakeholder in order to kill the deal. The parties called off the deal in February 2005. and nominated a slate of board members to change the direction of Mylan; he won three seats in May 2005. In June, the company bought back 25% of its shares in order to fend off Icahn. In July, Icahn gave up his bid and sold his shares.
Matrix acquisition In January 2007, the company acquired a controlling interest in Matrix Laboratories, an Indian supplier of
active pharmaceutical ingredients, for approximately $736 million, with the takeover including all of Matrix's subsidiary firms, for example Docpharma. It was at the time the largest-ever takeover in the Indian pharma industry and also gave access to markets in China, India, and Africa.
EpiPen acquisition In October 2007, the company acquired the generics division of
Merck KGaA for $6.6 billion. The company acquired the rights to market the EpiPen in the transaction. At that time annual sales were around $200 million In 2009, the company filed two lawsuits against the
Pittsburgh Post-Gazette after the newspaper ran an article that was critical of the quality control procedures used at the company's Morgantown plant. The company had earlier quality control issues involving the FDA. The lawsuits were dropped in 2012 without any damages paid by the Post-Gazette, which stated "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise." Also in 2009, the company and its subsidiary UDL agreed to pay $118 million to settle a suit filed under the
False Claims Act in which Mylan/UDL and two other companies were accused of underpaying states under the
Medicaid Drug Rebate Program. The program requires drug companies to give rebates to states under Medicaid and the rebates are higher for new drugs than for generics; the suit said that the companies sold new drugs but paid rebates as if they were generics.
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. The company launched the product in the UK in 2015 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.
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. 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." After successful lobbying from the company,
Joe Manchin, the father of Mylan's CEO, was a senator at that time. 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.
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. 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.
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.
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. In July, Teva dropped its bid for Mylan and instead acquired
Allergan's generic drug business for about the same price.
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.
Meda acquisition In February 2016, the company announced it would acquire
Meda AB for $9.9 billion. In May 2016, the company announced it would acquire Renaissance Acquisition Holdings dermatology division for up to $1 billion. 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. 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. In May 2018, the company announced a collaboration with West Virginia University to provide children across West Virginia with
STEM education.
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.
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.
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. In November 2019, Mylan & Upjohn announced that the name of the new company would be
Viatris. 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. The deal was structured as an all-stock,
Reverse Morris Trust transaction. Pfizer shareholders owned 57% of the combined new company and Mylan shareholders owned 43%.
Stock On February 23, 1973, the company became a
public company via an
initial public offering (IPO), on the
OTC market. In 1976, the stock moved to
NASDAQ and in 1986, it moved to the
New York Stock Exchange, then later back to NASDAQ.
Acquisition history The following is an illustration of the company's major mergers and acquisitions and historical predecessors: •
Mylan (Founded 1961) • Somerset Pharmaceuticals (Acq 1989) • Dow B. Hickam (Acq 1991) • Bertek Inc (Acq 1993) • UDL Laboratories (Acq 1996) • Penederm Inc (Acq 1998) • Matrix Laboratories (Acq 2007) •
Merck KGaA (Generics div.) (Acq 2007) • Bioniche Pharma Holdings (Acq 2010) •
Pfizer Respiratory Delivery Platform (Acq 2011) • Agila Specialties (Acq 2013) •
Abbott Laboratories (Generics div.) (Acq 2014) • Famy Care (Acq 2014) •
Meda (Acq 2016) • Renaissance Acquisition Holdings (Dermatology div.) (Acq 2016) ==Criticism==