Mylan Inc. 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 US 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. The plaintiffs filed suit against the Mylan companies in the United States District Court in the District of Delaware.
For the 12 months ending Dec. 31, 2014, Nexavar had US 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.
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