Ranbaxy reaches agreement with Astellas

Ranbaxy Laboratories Ltd on November 08, 2007 has announced that the Company 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 the Company and Astellas / Boehringer Ingelheim has been dismissed without prejudice. The lawsuit in the U.S. was related to Astellas' U.S. Patent No. 4,703,063 ('063 patent), covering Tamsulosin and its use in the treatment for functional symptoms of BPH (benign prostatie hyperplasia).

Under the agreement, the Company will enter the U.S. market on March 02, 2010, eight weeks prior to expiration of the pediatric exclusivity, which is likely to be granted to the innovator Company. During this time period of pediatric exclusivity, the Company will be the only generic manufacturer to commercialize this product in the U.S. market. The Company 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 USD 1.2 Bn (source IMS).

On June 20, 2007, the Company received tentative approval from the U.S. FDA in regards to its Tamsulosin ANDA No. 77-451.

The Company will continue to pursue a strategy to effectively optimize 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 ~ USD 26 Bn valued at innovator prices.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.