Mylan’s product is a generic version of Zytiga (abiraterone), which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer, i.e. prostate cancer that has spread to other parts of the body.

There are currently no generics of abiraterone on the market in the US and the US patents on Zytiga only expire in December 2016 and August 2027.

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 US District Court of New Jersey.

According to IMS Health, for the 12 months ending 30 June 2015, Zytiga had US sales of approximately US$1.08 billion.  Currently, Mylan has 268 ANDAs pending FDA approval representing US$101.3 billion in annual brand-name sales, fifty of these pending ANDAs are potential first-to-file opportunities, representing US$33.4 billion in brand-name sales for 2014.

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