Ranbaxy Laboratories, has reached an agreement with Astellas/Boehringer Ingelheim to stipulate a remand of the pending Federal Circuit appeal and subsequent vacatur of the District Court decision in regards to Flomax (Tamsulosin capsules).

Ranbaxy Laboratories has reached an out-of-court settlement with Japanese company Astellas and Boehringer Ingelheim to sell Flomax, a drug used in the treatment of benign enlargement of prostate, in the US. Boehringer Ingelheim has the exclusive marketing rights for the drug in the US.

The case between Ranbaxy and Astellas/Boehringer Ingelheim has been dismissed without prejudice.  The lawsuit in the US was related to Astellas’ US Patent No. 4,703,063 (‘063 patent), covering Tamsulosin and its use in the treatment for functional symptoms of benign prostatic hyperplasia (BPH). As part of the agreement, Ranbaxy will enter the US market on March 2, 2010, eight weeks before the expiration of the pediatric exclusivity, which is likely to be granted to the innovator company.  During this period exclusivity, Ranbaxy will be the only generic manufacturer to commercialize this product in the US market. The total annual sales of Flomax are estimated to be $1.2 billion.