Actavis, Inc. (ACT) and Kissei Pharmaceutical Co., Ltd. on Wednesday confirmed that they have filed lawsuits against Sandoz Inc., Hetero USA, Inc., Hetero Labs Limited and Hetero Labs Limited, Unit III in the U.S. District Court for the District of Delaware for infringement of U.S. Patent covering Rapaflo, a treatment for the signs and symptoms of benign prostatic hyperplasia or BPH.
Actavis and Kissei's lawsuits were filed in response to Abbreviated New Drug Applications filed by each of Sandoz and Hetero seeking U.S. Food and Drug Administration 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, the company said.
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