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www.fdanews.com/articles/101607-epo-holds-astrazeneca-s-nexium-prilosec-formulation-patent-valid

EPO Holds AstraZeneca's Nexium, Prilosec Formulation Patent Valid

November 29, 2007

The European Patent Office (EPO) has upheld one of AstraZeneca’s formulation patents covering Losec — marketed in the U.S. as Prilosec — and Nexium.

Although several generic companies challenged the patent, the EPO ruled that the ’437 patent is valid in amended form through 2015, AstraZeneca said. The patent covers the company’s heartburn drugs in 20 European countries.

The generic drugmakers involved were Hexal, Krka, Teva Pharmaceutical Industries and ratiopharm, according to AstraZeneca. The companies could not be reached for comment by press time.

The ’437 patent covers multiple-unit pellet tablets consisting of a proton-pump inhibitor compound. In October, the EPO held AstraZeneca’s process patent for Nexium (esomeprazole magnesium) valid in its amended form.

AstraZeneca noted that the intellectual property portfolio protecting Nexium includes additional patents with expiration dates ranging from 2009 to 2018. In addition to patent protection, Nexium has data exclusivity until March 2010 in most major European markets.