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news.Actavis and Kissei Pharmaceutical have filed lawsuits under the provisions of the Hatch-Waxman Act against Sandoz and Hetero USA over Rapaflo US patent infringement.
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Rapaflo is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH).
The lawsuits were filed in the US District Court for the District of Delaware in response to Sandoz and Hetero seeking FDA marketing approval for generic Rapaflo (Silodosin 4-mg and 8-mg capsules) earlier to Rapaflo patent expiration.
According to the Hatch-Waxman Act, FDA is supposed to cease from approving the Sandoz and Hetero abbreviated new drug applications before 8 April 2016, or until a district court rules against patent infringement or validity.