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Generic Prilosec OTC ANDA Filed By Perrigo Partner Dexcel; AstraZeneca Sues

This article was originally published in The Tan Sheet

Executive Summary

Perrigo has acquired marketing rights for a potential generic version of Prilosec OTC, but litigation against the firm's partner Dexcel Pharma by AstraZeneca could block generic OTC omeprazole through 2019

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Private-label omeprazole gets final OK

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)...

Perrigo Expects To Launch Private Label Prilosec OTC In Early 2008

With a major legal hurdle out of the way, Perrigo expects to launch its "largest opportunity" - the first store brand OTC proton pump inhibitor - by the end of March 2008, the firm said Nov. 1

Tentative nod for Dexcel omeprazole

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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