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Fosinopril Sodium Tablets Approved by FDA
This approval follows an October 27, 2003 decision by the U.S. District Court for the Southern District of New York granting judgment in favor of Teva on the issue of non-infringement with regard to Bristol-Myers Squibb's Monopril® Patent No. 5,006,344.
As the first company to file an ANDA with a Paragraph IV patent certification for this product, Teva became eligible for 180 days marketing exclusivity for this product from the date of last month's court decision.
Fosinopril Sodium Tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Monopril® Tablets. This product is indicated for the treatment of hypertension and management of congestive heart failure. Annual sales of the brand product through June 2003 were $267 million.
Source: Teva Pharmaceutical Industries Ltd.