Mylan N.V. (Nasdaq: MYL) today confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research & Development, LLC in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, 250 mg. 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 178 ANDAs pending FDA approval representing $83.8 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2014, according to IMS Health.