Ranbaxy fails to get FDA's nod, misses exclusive rights

Ranbaxy Laboratories today said it has failed to get the US health regulator's nod for launching generic version of Flomax, a prostrate drug, thereby missing the opportunity to launch the drug in America with exclusive marketing rights.

Flomax is a patent medicine from Japanese drug maker Astella Pharma's portfolio and the drug is also known by its generic name -- Tamsulosin hydrochloride.

"We regret that, despite our best efforts, we were not able to get an approval for the product (Flomax), and hence will not be in a position to launch the product," a Ranbaxy sokesperson said.

Earlier in 2007, Ranbaxy Laboratories had signed an agreement with Astellas and Boehringer Ingelheim for ending the patent litigation regarding Flomax drug in the US court.

Under the terms of agreement, Ranbaxy was supposed to enter the US market on March 2, 2010, eight weeks prior to expiration of the pediatric exclusivity.

During the period of pediatric exclusivity, Ranbaxy will be the only generic manufacturer to commercialise this product in the US market.

However, the Gurgaon-based company has failed to get the approval from the US Food and Drug Administration (FDA), which is mandatory before launching the drug in American market. Thus, the company missed the opportunity to launch the drug in US market with exclusivity.

The total annual sales of Flomax are estimated to be $1.2 billion in the US.