Mylan Inc. confirmed Monday that it and its subsidiary, Mylan Pharmaceuticals, have been sued by Onyx Pharmaceuticals, Bayer Healthcare, LLC, and Bayer Healthcare Pharmaceuticals, Inc., in connection to an application to make a generic form of NEXAVAR.
Mylan submitted an Abbreviated New Drug Application (ANDA) for 200 mg. Sorafenib tablets to the U.S. Food and Drug Administration (FDA) and considers itself the first company to have filed a complete ANDA with a Paragraph IV certification for Sorafenib. After receiving final FDA approval, the company expects eligibility for 180 days of marketing exclusivity.
Sorafenib is the generic version of NEXAVAR, a treatment for unresectable hepatocellular carcinoma, advanced renal cell carcinoma and other types of cancers. U.S. sales of NEXAVAR reached approximately $48 million in 2014, according to IMS Health.
According to IMS Health, Mylan currently has 283 ANDAs pending FDA approval – representing $107.1 billion in yearly sales. Of the pending ANDAs, 43 are possible first-to-file opportunities and represented $27.2 billion in brand sales for the 12 months ending June 30, 2014.
Mylan Inc. is a pharmaceutical distributor that employs 25,000 people providing products to customers in 140 countries and territories. The plaintiffs filed the lawsuit in the United States District Court in the District of Delaware.
Alerts Sign-up