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Pharmaceutical industry

Mylan Confirms First-to-File Patent Challenge Relating to Nexavar

Strategic Insights

— 2 min read

Mylan Inc. has confirmed that it and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Sorafenib Tablets, 200 mg. This product is the generic version of NEXAVAR, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Mylan believes that 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.

Key Takeaways:

  • Mylan and its subsidiary have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. over the filing of an ANDA for Sorafenib Tablets, 200 mg.
  • The product is the generic version of NEXAVAR, used to treat certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
  • Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for this product.
  • The company expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
  • The plaintiffs filed suit against Mylan in the United States District Court in the District of Delaware.
  • For the 12 months ending Dec. 31, 2014, NEXAVAR had U.S. sales of approximately $48 million, according to IMS Health.
  • Currently, Mylan has 283 ANDAs pending FDA approval representing $107.1 billion in annual sales, according to IMS Health.
  • Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $27.2 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
  • Mylan has a global workforce of more than 25,000 people, committed to improving the customer experience and increasing pharmaceutical access to consumers around the world.

Statistics:

  • 180 days of marketing exclusivity for Mylan upon receiving final FDA approval.
  • $48 million in U.S. sales for NEXAVAR for the 12 months ending Dec. 31, 2014, according to IMS Health.
  • $107.1 billion in annual sales for Mylan's 283 pending ANDAs, according to IMS Health.
  • $27.2 billion in annual brand sales for 43 potential first-to-file opportunities, for the 12 months ending June 30, 2014, according to IMS Health.

Sources:

  • PR Newswire - "Mylan Confirms First-to-File Patent Challenge Relating to Nexavar" (February 9, 2015)
  • Mylan Inc. - Private Securities Litigation Reform Act of 1995 - A Caution Concerning Forward-Looking Statements
  • IMS Health - sales data for NEXAVAR and Mylan's pending ANDAs (December 31, 2014, and June 30, 2014)

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