BTG International Limited, Janssen Biotech, and various other Janssen affiliates filed a patent infringement suit on 31 July 2015 in the U.S. District Court for the District of New Jersey seeking to prevent Hikma from commercialising its ANDA product prior to the expiration of U.S. Patent No. 8,822,438. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Hikma’s ANDA until 28 October2018.

Based on available information, Hikma believes it may be a “first applicant” to file an ANDA for the generic version of ZYTIGA® and, should its ANDA be approved, may be entitled to 180 days of generic marketing exclusivity.

For the twelve-month period ending June 2015, ZYTIGA® achieved U.S. sales of approximately $1.1 billion according to IMS Health Data.