Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the Company?s Abbreviated New Drug Application (ANDA) for Rabeprazole Sodium Delayed-Release Tablets, 20 mg.
Teva?s Rabeprazole Sodium Delayed-Release Tablets are the AB-rated generic equivalent of Eisai?s acid pump inhibitor Aciphex? Tablets. The brand product had annual sales of approximately $1.3 billion, based on 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 a 180-day period of marketing exclusivity.
Teva is currently in patent litigation concerning this product in the U.S. District Court for the Southern District of New York. A suit was brought against Teva in November 2003 involving Teva’s paragraph IV certification to U.S. Patent No. 5,045,552. A trial has been scheduled for March 5, 2007.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.