US court clears way for launch of Allegra D24 by Dr Reddy’s

Dr Reddy’s Laboratories (DRL) has secured regulatory approval for launch of its generic anti-histamine Allegra D24 in the US.

The company, which has had to wait for more than six months to overcome the legal hurdles, is gearing up to launch the drug in both over the counter and prescription markets.

The market for Allegra D24 is estimated at $150-180 million. DRL had received US FDA nod for launching fexofenadine hydrochloride/ pseudoephedrine hydrochloride (Allegra D24) in March 2010.

However, the drug’s innovator, Sanofi Aventis, blocked DRL’s plan to launch the drug by seeking an injunction in a US court in June 2010. By the time the US court had granted the injunction, DRL’s product was still not in the market.

After protracted claims and counter claims, the US district court of New Jersey has lifted the preliminary injunction on DRL’s product, paving the way for the generic Allegra D24 to hit the market.