HYDERABAD, India, April 13 (UPI) -- Dr. Reddy's said Thursday it has been approved to market a generic version of Sanofi-Aventis' allergy drug Allegra.
The India-based drug firm said the Food and Drug Administration has approved its fexofenadine hydrochloride tablets in 30 mg, 60 mg and 180 mg strengths. Dr. Reddy's said it would launch the product immediately.
Dr. Reddy's estimated U.S. sales of Allegra at about $1.4 billion.
The company said it filed for approval of the generic drug and challenged the patents covering Allegra in September 2002.
Dr. Reddy's said it was granted summary judgment on three of the patents, while the dispute over five additional Allegra patents is still pending before the U.S. District Court for the District of New Jersey. The trial date to resolve the remaining patent issues has not been set.
The path to market for Dr. Reddy's generic allergy drug was cleared by expiration of the 30-month stay of FDA approval while the patent litigation was ongoing, as well as expiration of six months of market exclusivity granted to Barr Laboratories, which was the first to launch a generic version of Allegra.
The drug is indicated for symptomatic relief associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
