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.