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Perrigo’s omeprazole OTC?

This article was originally published in The Tan Sheet

Executive Summary

FDA issues an approvable letter to Perrigo's Israeli partner, Dexcel Pharma Technologies, for its generic Prilosec OTC (omeprazole 20 milligrams) new drug application on Dec. 18, according to the Allegan, Mich.-based firm in a same-day release. Perrigo plans on being the exclusive marketer and distributor of Dexcel's generic Prilosec OTC in the U.S. once the agency approves the application, the firm states. Currently, the company is facing pending litigation from AstraZeneca over the generic version of the over-the-counter heartburn drug. Dexcel filed the ANDA for OTC omeprazole in April 2006. Patent-holder AstraZeneca filed lawsuits in Delaware and Virginia in late May, alleging Dexcel's application infringes on three patents: two expiring in Oct. 2007 and one slated to expire in May 2019 (1"The Tan Sheet" June 12, 2006, p. 5). The litigation has initiated the patent challenge process under Hatch/Waxman and places a 30-month stay on FDA approval of the generic Prilosec OTC...

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