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Prilosec patent litigation

This article was originally published in The Tan Sheet

Executive Summary

New York federal court upholds validity of AstraZeneca's two formulation patents and rules that three of four companies involved in Rx omeprazole patent litigation - Andrx, Dr. Reddy's and Genpharm - infringe those patents. However, Schwarz Pharma's product does not infringe, Judge Barbara Jones says in Oct. 11 ruling. Decision is not expected to impact AstraZeneca/P&G's eventual OTC sale of the proton pump inhibitor. OTC Prilosec would carry a claim for prevention of frequent heartburn - which differs from the approved Rx indication - and is expected to garner three-year Hatch/Waxman exclusivity. P&G anticipates FDA approval of the OTC switch in first quarter of 2003...

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