In another victory for generic drug makers over global pharmaceutical giants, a US court has allowed Hyderabad-based Dr Reddy's Laboratories Ltd to sell a generic version of Sanofi-Aventis SA's anti-allergy drug, Allegra D-24 in the US.
The launch of this product is significant for Dr Reddy's as the company will be the only pharmaceuticals firm selling the drug's generic version, enabling it to enjoy better margins and likely boosting its profit and sales in the financial year through March and the next.
Allegra D-24 tablets are a once-daily treatment for allergy symptoms such as nasal congestion in adults and children aged 12 years or older. The estimated market size for Allegra D-24 in the US is pegged at about $150 million.
Dr Reddy's had received the US Food and Drug Administration's approval to make and sell fexofenadine hydrochloride 180 milligram and pseudoephedrine hydrochloride 240 mg tablets, the generic version of Allegra D-24, in March 2010. It was the first to file a generics application for the drug with the FDA.
However, it couldn't launch the product as the US district court of New Jersey in June 2010 granted Sanofi-Aventis and Albany Molecular Research Inc, the innovator of the drug, a preliminary injunction on the drug's sale.
Dr Reddy's, which appealed the order, said Monday that the court lifted the injunction on 28 January and asked Sanofi-Aventis and Albany Molecular to deposit $40 million as security with the court toward the possibility that the injunction had been wrongfully granted.