Mylan Inc. Sued by Bayer Healthcare in Connection with Filing of Abbreviated New Drug Application for Sorafenib Tablets

Strategic Insights -

Mylan Inc. and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. in the United States District Court in the District of Delaware. The lawsuit is connected to the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Sorafenib Tablets, 200 mg, the generic version of NEXAVAR. Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval. This development is significant, given the substantial market potential of the drug, with NEXAVAR having generated U.S. sales of approximately $48 million for the 12 months ending Dec. 31, 2014, according to IMS Health. Mylan's robust pipeline of 283 ANDAs pending FDA approval represents $107.1 billion in annual sales, with 43 potential first-to-file opportunities, which could be worth $27.2 billion in annual brand sales.

Key Takeaways:

  • Mylan Inc. and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. in the United States District Court in the District of Delaware over the filing of an ANDA for Sorafenib Tablets, 200 mg.
  • Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
  • The product in question is the generic version of NEXAVAR, which had U.S. sales of approximately $48 million for the 12 months ending Dec. 31, 2014, according to IMS Health.
  • Mylan's pipeline of 283 ANDAs pending FDA approval represents $107.1 billion in annual sales, with 43 potential first-to-file opportunities worth $27.2 billion in annual brand sales.
  • Mylan is a global pharmaceutical company with a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications.
  • The company has a workforce of over 25,000 people and operates in approximately 140 countries and territories.

Statistics:

  • $48 million: U.S. sales of NEXAVAR for the 12 months ending Dec. 31, 2014 (IMS Health)
  • $107.1 billion: Annual sales represented by Mylan's pipeline of 283 ANDAs pending FDA approval (IMS Health)
  • $27.2 billion: Annual brand sales represented by 43 potential first-to-file opportunities in Mylan's pipeline (IMS Health)
  • 25,000: Number of people in Mylan's workforce
  • 140: Number of countries and territories where Mylan operates
  • 1,300: Number of generic pharmaceuticals in Mylan's portfolio
  • 43: Number of potential first-to-file opportunities in Mylan's pipeline

Sources:

  • Mylan Inc.
  • NewsRx LLC (pharmaceutical news provider)
  • IMS Health (market research and consulting firm)
  • U.S. Food and Drug Administration (FDA)
  • Bayer Healthcare LLC
  • Bayer Healthcare Pharmaceuticals Inc.
  • Onyx Pharmaceuticals Inc.