Ranbaxy fails to get FDA nod, misses exclusive rights

The pharmaceutical company has failed to get the US FDA’s approval for launching the generic version of Flomax, thereby missing the opportunity to launch the drug in America with exclusive marketing rights

Pharmaceutical company Ranbaxy Laboratories Ltd, a unit of Japan's Daiichi Sankyo Co, on Wednesday said that it has failed to get the US health regulator's nod for launching a generic version of Flomax, a prostrate drug, thereby missing the opportunity to launch the drug in America with exclusive marketing rights, reports PTI.

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 spokesperson said.

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

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

During the period of paediatric exclusivity, Ranbaxy would have been 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 the American market. Thus, the company missed an opportunity to launch the drug in the US market with exclusivity.

The total annual sales of Flomax are estimated to be $1.20 billion in the US.
 

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