Tokyo, Japan, September 24, 2009 - Astellas Pharma Inc. (headquarters: Tokyo; President and CEO: Masafumi Nogimori; “Astellas”) and its US affiliate Astellas Pharma US, Inc. (headquarters: Deerfield, IL; “Astellas Pharma US”) jointly filed a patent infringement lawsuit in the US against Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc. (“Teva”) regarding its submission of an abbreviated new drug application (ANDA) for a generic version of Astellas’s solifenacin succinate tablets sold under the trademark VESIcare®, which is used for the treatment of overactive bladder. The patent infringement action was filed at the United States District Court, Southern District of New York on September 22, 2009 requesting, among others, an order that the date of approval of Teva’s ANDA be not earlier than the expiration of Astellas’s US Patent No. 6,017,927 on solifenacin succinate, or any later date of exclusivity Astellas are or become entitled.
Solifenacin succinate was invented by Astellas and has been marketed in approximately 50 countries/areas since it was launched in Europe in 2004. In the US, Astellas Pharma US has been marketing and co-promoting the product with GlaxoSmithKline since 2005 under the brand name VESIcare.
Astellas believes that the patent is valid and intends to enforce it against infringement.
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