Armed with final approval from the US FDA, Dr Reddy?s Laboratories is gearing up to launch the generic version of Sanofi Aventis? anti-allergic drug, Allegra D-24. The version will hit the market during the first quarter of the next financial year.
DRL claims that it is the only company to get this approval, as there were no other filers. Despite a preliminary injunction obtained by Sanofi Aventis, DRL is hoping to get an extended marketing period, which could be more than 180 days, owing to the first mover advantage.
Sources in the know said this would be more of an ?at-risk launch? because of the ongoing litigation. The company received approval last week from the US FDA to market the generic version. According to available reports, the market size for this drug is around $200 million.
When asked, a DRL spokesperson said, ?We are moving forward with the launch activities of Allegra D-24.?? However, the company refused to divulge details about the exact timing of the launch.
As a start, Albany Molecular Research, along with Sanofi Aventis SA?s US unit, has sought a preliminary injunction against DRL from distributing a generic version of the allergy drug.
The company?s reaction, filed in a federal court in New Jersey, comes as a response to the US health regulator?s approval for DRL?s generic version on March 17. In fact, Albany Molecular had sued DRL last September alleging infringement of patents related to the manufacturing process of the drug while Sanofi-Aventis holds the patent.