Ranbaxy Laboratories Ltd 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).

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 BPH (benign prostatic hyperplasia).

Under the agreement, Ranbaxy will enter the US market on March 2, 2010, eight weeks prior to expiration of the paediatric exclusivity, which is likely to be granted to the innovator company. During this time period of paediatric exclusivity, Ranbaxy will be the only generic manufacturer to commercialise this product in the US market. Ranbaxy believes that its Tamsulosin ANDA is the first substantially complete ANDA with a Paragraph IV certification to the '063 patent. The total annual sales of Flomax are estimated to be US $1.2 bn.

On June 20, 2007, Ranbaxy received tentative approval from the US FDA in regards to its Tamsulosin ANDA No. 77-451. Ranbaxy will continue to pursue a strategy to effectively optimise its pipeline of First-to File (FTF) opportunities. The company believes that it has a FTF status on approximately 17 paragraph IV ANDA filings representing a market size of US $26 bn valued at innovator prices.