In a bid to tap the $452-million Fexofenadine drug market, Dr Reddy’s Laboratories today announced the launch of generic version of Allegra — Fexofenadine HCl — tablets in the US market.

The Food & Drug Administration (FDA) approved Dr Reddy’s abbreviated new drug application (ANDA) for Fexofenadine HCl tablets on April 12.

The pharmaceutical firm will market the over-the-counter product under store brand labels in the US market.

The products are bio equivalent versions of Sanofi-Aventis’ Allegra tablets which received Rx-to-OTC switch approval from the FDA on January 24.

In January, the US District Court of New Jersey cleared the decks for Dr Reddy’s Laboratories, the country’s second-biggest drug maker, to launch the generic version of Allegra-D 24 in the US.

The US Court had also ordered Sanofi-Aventis and Albany Molecular Research, which had earlier obtained an injunction against launching of the drug, to post a security of $40 million with the court towards the possibility that the injunction had been wrongfully granted.

Earlier, based on a request filed by AMRI and Sanofi-Aventis, the US District Court had granted a preliminary injunction on the launch of Allegra-D 24 (fexofenadine hydrochloride / pseudoephedrine hydrochloride 180/240 mg extended release tablet) in June last year.

In September 2009, AMRI filed a patent infringement lawsuit in the court against Dr Reddy’s for infringement of one of AMRI’s patents, related to the manufacturing process for the active ingredient in Allegra, Allegra-D 12, and Allegra-D 24 Hour.

AMRI joined hands with French drug maker Sanofi-Aventis SA, which sells Allegra and filed the law suit.

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