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Private-label omeprazole gets final OK

This article was originally published in The Tan Sheet

Executive Summary

FDA grants final approval to Israel-based Dexcel Pharma Technologies' 20 mg omeprazole delayed-release tablets, Perrigo announces Dec. 10. Perrigo will be the exclusive marketer and distributor of the store brand Prilosec OTC, and plans to begin distribution of the product during the first quarter of 2008, the Allegan, Mich.-private labeler states. The firm expects the generic omeprazole product to contribute $150 mil. to $200 mil. in sales in 2008, according to a release. The upcoming launch of the omeprazole product, which Perrigo CEO Joseph Papa expects to be the "largest product in Perrigo's 120-year history," comes after the private-labeler's November announcement of a settlement to litigation between Dexcel Pharma and AstraZeneca, the manufacturer of Prilosec OTC (1"The Tan Sheet" Nov. 5, 2007, p. 10). The settlement resolves a legal dispute that began when Dexcel filed a new drug application in April 2006 with a Paragraph IV certification asserting AstraZeneca's Prilosec OTC patents were invalid and would not be infringed by its generic version of the drug (2"The Tan Sheet" June 12, 2006, p. 5)...

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