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news.Astellas pharma and Boehringer Ingelheim Pharmaceuticals have jointly filed a patent infringement lawsuit in the US against Impax laboratories regarding its submission of an abbreviated new drug application for a generic version of Astella's tamulosin hydrochloride capsules.
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The patent infringement action was filed at the US District Court of California requesting, among others, an order that the date of approval of Impax’s ANDA be not earlier than the expiration of Astella’s US patent on tamulosin hydrochloride, or any later date of exclusivity Astellas and BIPI are or become entitled.
In the US under a license from Astellas, BIPI has been marketing the product since 1997 under the brand name Flomax. Astellas believes that the patent is valid and intends to enforce it against infringement.
Astellas’s tamulosin hydrochloride capsules are used for the treatment of the signs and symptoms of benign prostatic hyperplasia.