Mylan has been sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen R&D in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Abiraterone Acetate Tablets, 250mg. 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 the 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 U.S. District Court for the District of New Jersey.
For the 12 months ending June 30, Zytiga had U.S. sales of about $1.08 billion, according to IMS Health.