Mylan

Mylan was a global pharmaceutical company renowned for developing, licensing, manufacturing, marketing, and distributing generic, brand-name, and over-the-counter medications. Founded in 1961, it grew into one of the world's largest generic drug manufacturers, operating in over 165 countries and territories. The company was a major producer of products ranging from complex injectables to biosimilars and played a significant role in increasing access to affordable medicines. In November 2020, Mylan merged with Upjohn, a division of Pfizer, to form a new company named Viatris.

History

Mylan was founded in 1961 by Milan Puskar and Don Panoz as a pharmaceutical distributor in White Sulphur Springs, West Virginia. The company began manufacturing operations in 1966 and went public in 1973. A pivotal moment came in the 1980s under the leadership of Roy McKnight with the successful challenge of a patent for clonidine, establishing Mylan's aggressive stance in the generic drug industry. Major expansion occurred through acquisitions, including the 2007 purchase of Merck KGaA's generics division, which significantly boosted its international presence, particularly in Europe and emerging markets like India. In 2015, Mylan acquired the Perrigo Company after a hostile takeover attempt and completed a large-scale corporate inversion, moving its legal domicile to the Netherlands while maintaining its operational headquarters in Canonsburg, Pennsylvania.

Business operations

Mylan operated a highly integrated global supply chain with over 40 manufacturing sites worldwide. Its business model focused on a broad portfolio of generic and specialty pharmaceuticals, with key operational hubs in the United States, India, and the European Union. The company maintained one of the industry's largest Abbreviated New Drug Application (ANDA) portfolios with the U.S. Food and Drug Administration. A significant part of its strategy involved developing complex generics and biosimilars, such as copies of Herceptin and Avastin, through its Biologics division. Mylan also operated a substantial over-the-counter drug business and had a notable presence in antiretroviral therapy for HIV/AIDS through partnerships with entities like the Clinton Health Access Initiative.

Products

Mylan's product portfolio encompassed thousands of medications across numerous therapeutic areas. Key products included EpiPen Auto-Injector, for which it was the longtime manufacturer and marketer in partnership with Pfizer. The company was a leading global supplier of antiretroviral drugs for treating HIV, including a widely used fixed-dose combination. Other significant products ranged from generic versions of Lipitor (atorvastatin) and Nexium (esomeprazole) to specialty pharmaceuticals like the severe asthma treatment Perforomist. Its diverse pipeline included generic versions of complex products like Copaxone and biosimilars referenced to blockbuster biologics from companies like Roche and Amgen.

Legal and regulatory issues

Mylan faced numerous legal and regulatory challenges throughout its history. Most notably, it came under intense scrutiny from the U.S. Congress, the Department of Justice, and the Federal Trade Commission for dramatic price increases on the EpiPen, leading to a $465 million settlement with the U.S. government over Medicaid classification. The company was also involved in multiple antitrust lawsuits, including allegations of price-fixing in the generic drug industry alongside competitors like Teva Pharmaceutical Industries and Novartis. Regulatory issues included FDA warnings over manufacturing practices at facilities in Morgantown, West Virginia and India, and a 2016 settlement with the Securities and Exchange Commission regarding disclosure controls related to its inversion transaction.

Corporate affairs

Mylan's corporate leadership was long associated with the Puskar family, with Heather Bresch, daughter of co-founder Milan Puskar, serving as CEO from 2012 to 2020. The company was known for its advocacy on drug pricing and access issues, often testifying before committees like the House Oversight Committee. It engaged in significant corporate social responsibility initiatives, particularly in expanding access to medicines in the developing world through its "Mylan Cares" program. The merger with Upjohn to form Viatris was positioned as a strategic move to create a stronger global healthcare company, with the transaction receiving regulatory approvals from bodies including the European Commission and closing in November 2020.

Category:Pharmaceutical companies of the United States Category:Companies established in 1961 Category:Companies disestablished in 2020