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Tentative nod for Dexcel omeprazole

This article was originally published in The Tan Sheet

Executive Summary

FDA has granted tentative approval for Dexcel Pharma Technologies' new drug application for its generic Prilosec OTC (omeprazole 20 mg), which could be held up by AstraZenca's patent litigation, Perrigo says June 20. Allegan, Mich.-based Perrigo has exclusive U.S. marketing and distribution rights for Dexcel's product. Perrigo says FDA's final approval of the generic Prilosec OTC will not come until the expiration of the 30-month period provided for AstraZeneca under the Hatch-Waxman Act, which would be November 2008. However, trial is expected to begin later this year in U.S. District Court for Delaware in the patent infringement suit AstraZeneca filed in May 2006 against Dexcel, alleging the Israel-based firm's application infringes on three patents: two expiring in October 2007 and one in May 2019. The litigation initiated the patent challenge process under Hatch-Waxman (1"The Tan Sheet" June 12, 2006, p. 5)...
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