Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)announced that the U.S. District Court for the Southern istrict of New York has issued a decision in its litigation over the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Eisai’s acid pump inhibitor Aciphex? (Rabeprazole Sodium) Tablets, 20 mg.
The Court found Eisai’s U.S. Patent No. 5,045,552 enforceable. Teva intends to appeal this decision immediately as well as the Court’s decision granting to Eisai Summary Judgment of validity.
The FDA has already granted final approval for Teva’s Abbreviated New Drug Application (ANDA) for Rabeprazole Sodium Delayed-Release Tablets, 20 mg. As one of the first companies to file an ANDA with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product, which will start on the earlier of the date of first commercial launch or a final court decision.
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.