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

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News

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

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This product is the generic version of Zytiga┬«, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. 

Mylan believes it is one of the first companies 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 final FDA approval. The plaintiffs have filed a lawsuit against Mylan in the United States District Court for the District of New Jersey.

For the 12 months ending June 30, 2015, Zytiga had U.S. sales of approximately $1.08 billion, according to IMS Health.

Currently, Mylan has 268 ANDAs pending FDA approval representing $101.3 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.

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