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Prilosec patent ruling

This article was originally published in The Tan Sheet

Executive Summary

Omeprazole generics status quo unchanged by a federal appeals court's Dec. 11 ruling affirming that Schwarz' generic does not infringe AstraZeneca's Prilosec patents, but that ANDAs filed by Andrx, Genpharm and Dr. Reddy's do infringe. Federal Circuit upheld a New York trial court's October 2002 ruling, which led to an agreement by Andrx and Genpharm to relinquish their first-to file exclusivity rights on omeprazole to Schwarz in exchange for a profit-sharing agreement on its Kudco subsidiary's product. Schwarz' position as the sole generic entry ended in August, when "second wave" defendants Mylan and Novartis' Lek division launched at risk with litigation pending in the trial court...
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