Ranbaxy, Astellas, Boehringer reach deal over Flomax

MUMBAI: Ranbaxy Laboratories Ltd has reached an agreement with Astellas / Boehringer Ingelheim over Flomax (Tamsulosin capsules) patent. The case related to Astellas' US Patent No. 4,703,063 ('063 patent) covering Tamsulosin and its use in the treatment for functional symptoms of benign prostatie hyperplasia.

Under the agreement, Ranbaxy will enter the US market on March 2, 2010, eight weeks prior to expiration of the pediatric exclusivity. During this period, the company will be the only generic manufacturer to commercialise this product in the US.

Ranbaxy’s Tamsulosin ANDA is the first substantially complete ANDA with a Paragraph IV certification to the '063 patent, it claims. The total annual sales of Flomax are estimated to be $1.2 billion. On June 20, 2007, Ranbaxy received tentative approval from the US FDA in regards to its Tamsulosin ANDA No. 77-451. At 1:47 pm, Ranbaxy Laboratories shares were up 0.76 per cent at Rs 430.45 on BSE.