TEVA WINS APPROVAL FOR GENERIC ACIPHEX
Teva Pharmaceutical Industries announced that the FDA has granted final approval to its abbreviated new drug application (ANDA) for rabeprazole sodium delayed-release tablets, 20 mg.
The product is the AB-rated generic equivalent of Eisai's acid pump inhibitor Aciphex. The drug is indicated for treating gastroesophageal reflux disease and duodenal ulcers. Aciphex has annual sales of approximately $1.3 billion, Teva said, citing IMS sales data.
As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded 180 days of marketing exclusivity.
Teva is currently in patent litigation concerning this product in a U.S. district court, and a trial has been scheduled for March.