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| Edited By: KV Ramana |Source: DNA |Updated: Mar 18, 2018, 02:30 AM IST
Dr Reddy’s Laboratories has launched fexofenadine hydrochloride tablets in the US. The drug would be sold over the counter.
Fexofenadine, an antihistamine drug used in the treatment of hay fever and similar allergy symptoms, has a market worth over $450 million.
“Dr Reddy’s will market the product under store brand labels in the US market. The products are bioequivalent versions of Sanofi-Aventis’s Allegra tablets, which received Rx-to-OTC switch approval from the FDA on January 24, 2011. The Fexofenadine HCl Rx (prescription) market had brand and generic sales of approximately $452 million for the 12 months ending December 31, 2010 according to IMS Health,” a company statement said.
Dr Reddy’s abbreviated new drug application was approved by the US Food and Drug Administration on April 12. However, a litigation involving the generic version of Allegra D24, which is a combination of fexofenadine and pseudoephe-drine is still on in a US court. The company expects a favourable outcome shortly.
“What we are launching is plain Fexofenadine HCl. There is no pseudoephedrine in it. The patent infringement litigation is still on and the outcome is expected anytime,” a company official said.
Sanofi-Aventis and Albany Molecular Research had sought the intervention of a US court to restrain Dr Reddy’s from going ahead with the launch of Allegra D24. The US court had also ordered Sanofi-Aventis and Albany Molecular Research, which had earlier obtained an injunction against launching of the drug, to deposit a security of $40 million with the court towards the possibility that the injunction had been wrongfully granted.
Earlier, the US court had granted a preliminary injunction on the launch of Allegra-D 24 (fexofenadine hydrochloride/ pseudoephedrine hydrochloride 180 mg/ 240 mg extended release tablet) in June last year.
