Dr Reddy’s gets court nod to launch Allegra-D 24 tablets in US

PTI Hyderabad | Updated on January 31, 2011 Published on January 31, 2011

The US District Court of New Jersey has cleared the decks for Dr Reddy’s Laboratories, the country’s second-largest pharmaceutical maker to launch a generic version of Allegra-D 24 tablets in the US market, the Hyderabad-based company said on Monday.

According to Dr Reddy’s, the US Court has also ordered Sanofi-Aventis and Albany Molecular Research, which earlier obtained an injunction against the launch of the generic drug, to deposit a security of $40 million with the court in lieu of the possibility that the injunction had been wrongfully granted.

Based on a request filed by Albany Molecular Research Inc (AMRI), and Sanofi-Aventis, the US District Court had earlier granted a preliminary injunction on the launch of Allegra-D 24 (fexofenadine hydrochloride/pseudoephedrine hydrochloride) extended release tablets in 180 mg and 240 mg strengths by Dr Reddy’s in June last year.

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

AMRI joined hands with French drug-maker Sanofi-Aventis SA, which sells Allegra, to file the lawsuit.

Dr Reddy’s generic Allegra-D 24 drug was approved by the FDA on March 16, 2010. According to available reports, the US market for this drug is worth around $200 million.

With the news that the US court lifted its injunction order on the sale of Allegra-D 24, shares of Dr Reddy’s gained 2.25 per cent and were being traded at Rs 1,601.5 apiece on the Bombay Stock Exchange on Monday.

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Published on January 31, 2011
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