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Prilosec inquiry

This article was originally published in The Tan Sheet

Executive Summary

Stop Patient Abuse Now! (SPAN) coalition is calling on FTC and New York AG's office to launch an inquiry into whether Prilosec manufacturer AstraZeneca engaged in fraud. SPAN alleges AstraZeneca may have infringed on prior art by submitting a patent already held by a Korean firm to block generic competition in U.S. Group also claims New York consumers and taxpayers could save as much as $15 mil. a month if generic versions of the drug were approved. AstraZeneca, which along with P&G is seeking to switch the proton pump inhibitor OTC, is involved in ongoing patent litigation related to the drug (1"The Tan Sheet" July 9, 2001, In Brief and 2June 4, 2001, In Brief)...

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Delayed-release formulation patents for AstraZeneca's Rx proton pump inhibitor will be focus of infringement litigation following Manhattan federal court's invalidation of "method of treatment" patent for combining clarithromycin and omeprazole for treatment of gastritis and peptic ulcer. However, U.S. Judge Barbara Jones denied Genpharm's motion for summary judgment on AstraZeneca's claim that generic omeprazole will induce infringement of the method of treatment. Court's decision means two method of treatment patents may be taken up at trial along with two delayed-release formulation patents. In May, court rejected AstraZeneca's assertion that generic omeprazole would infringe patent for active metabolites of Prilosec, which is being considered for OTC switch (1"The Tan Sheet" June 4, In Brief)


Manhattan federal judge rejects AstraZeneca assertion generic omeprazole would infringe patent for active metabolites of Prilosec. '499 patent encompasses synthetic sulphenamides only, not those produced through in vivo conversion of omeprazole, court concludes May 29. Rulings on three antibiotic-related Prilosec patents expected in August in AstraZeneca's ongoing litigation against four generic firms. Basic omeprazole patent expires in October. Last year, two FDA advisory committees voted against OTC episodic heartburn relief indication for Prilosec but left open possibility of a chronic heartburn indication

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