Settlement Clears the Way for Generic Prilosec OTC

Dexcel Pharma Technologies has settled litigation with AstraZeneca involving three patents for 20-mg Prilosec OTC.

Under the agreement, Dexcel will be able to market a generic version of the heartburn product once it receives final FDA approval. Dexcel won tentative FDA approval for its delayed-release tablets in June.

Perrigo, Dexcel’s U.S. marketing partner, said it expects to launch the product by the end of the first quarter of 2008. While several companies market generic prescription Prilosec (omeprazole), none has received approval for a generic version of the OTC product.

AstraZeneca filed suit in the U.S. District Court for the District of Delaware in May 2006 after Dexcel submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC.

A spokesman for AstraZeneca said the litigation has been dismissed with prejudice, and the remaining terms of the settlement are confidential.