Teva Pharmaceutical launches Fexofenadine HCl and Pseudoephedrine HCl tablets

Nov 4 2009

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the commercial launch of Fexofenadine Hydrochloride 60 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, the same as the sanofi-aventis U.S. allergy treatment Allegra-D® 12 Hour (fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg) Extended-Release Tablets. Teva's product is an alternative to the brand product, which had annual sales of approximately $293 million in the United States for the twelve months that ended June 30, 2009, based on IMS sales data.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity in the U.S.

Teva is distributing the product, under a license agreement entered into between Teva's subsidiary Barr Pharmaceuticals, Inc. and sanofi-aventis U.S. Allegra-D is a registered trademark of sanofi-aventis U.S.