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TEVA ANNOUNCES APPROVAL OF GENERIC ACIPHEX

February 23, 2007

Israeli drugmaker Teva Pharmaceutical Industries announced that the U.S. 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 awarded180 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.