Actavis, Inc., a global, integrated specialty pharmaceutical company, and Kissei Pharmaceutical Co., one of Japan's leading pharmaceutical companies, have filed lawsuits against Sandoz Inc., Hetero USA, Inc. and Hetero Labs Limited, Unit III in the US District Court for the District of Delaware for infringement of US Patent No. 5,387,603 (the '603 patent) covering Rapaflo, a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH).
Actavis and Kissei's lawsuits were filed in response to Abbreviated New Drug Applications (ANDA) filed by each of Sandoz and Hetero seeking US Food and Drug Administration (FDA) approval to market a generic version of Actavis' Rapaflo (Silodosin 4-mg and 8-mg capsules) prior to the expiration of the '603 patent. The lawsuits were filed under the provisions of the Hatch-Waxman Act, accordingly, the FDA must refrain from approving the Sandoz and Hetero ANDAs prior to April 8, 2016, or until a district court decision finding that the '603 patent is invalid or not infringed, whichever occurs earlier.
Actavis, Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.
Kissei Pharmaceutical Co., one of Japan's leading pharmaceutical companiesand its vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around the world through developing and commercializing innovative drugs.