Tokyo, Japan, October 7, 2009 - Astellas Pharma Inc. (headquarters: Tokyo; President and CEO: Masafumi Nogimori) announced today that Astellas and Boehringer Ingelheim Pharmaceuticals, Inc. (a US subsidiary of Boehringer Ingelheim (headquarters: Germany), “BIPI”) have reached agreement with Impax Laboratories, Inc. (“Impax”) to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for FLOMAX® (generic name: tamsulosin hydrochloride capsules, brand name in Japan: Harnal®) through the entry of a consent judgment confirming the validity and infringement of the patent. FLOMAX is a treatment for the functional symptoms of benign prostatic hyperplasia. 

As a result of this settlement, the case has been terminated by the consent judgment.  The settlement of the litigation provides Impax with the opportunity to launch a generic tamsulosin hydrochloride product on or after March 2, 2010, prior to the expiration of pediatric exclusivity.  Further terms of the settlement will not be disclosed.




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