Ranbaxy settles prostate drug patent case

Ranbaxy Laboratories has reached a settlement with drug majors Astellas Pharma and  Boehringer Ingelheim on the patent infringement case relating to  Flomax (Tamsulosin capsules) used in the treatment of enlargement of the prostate.

In a communication to the Bombay Stock Exchange (BSE), the company said the case has been dismissed without prejudice.

According to the agreement, Ranbaxy will enter the US market on March 2, 2010 - eight weeks prior to expiration of the exclusivity of the patent, which is likely to be granted to the innovator company. During this time, Ranbaxy will be the only generic manufacturer to commercialise the product in the US market.

The total annual sales of Flomax, indicated for the treatment of BPH (benign prostatie hyperplasia), is estimated to be $1.2 billion. Ranbaxy is believed to be the first to challenge the patent on Flomax.

On June 20, 2007, Ranbaxy received tentative approval from the U.S. Food and Drug Administration (FDA) to market Tamsulosin.

Ranbaxy said the company has a FTF status on approximately 17 paragraph IV ANDA filings (patent challenging applications to market a product) representing a market size of  $26 billion - valued at innovator prices.

A few months ago, Ranbaxy had reached an agreement with GlaxoSmithKline (GSK) to stipulate a dismissal of their US litigation with regard to Valtrex (Valacyclovir Hydrochloride tablets).