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AstraZeneca PLC announces statement on esomeprazole strontium product launch in United States


Tuesday, 17 Dec 2013 01:13pm EST 

AstraZeneca PLC:Says that it is aware of reports that an 505(b)(2) NDA esomeprazole strontium product has been launched in the United States (US) by Hanmi Pharmaceutical and affiliates ("Hanmi") and its US marketing partner Amneal Pharmaceuticals ("Amneal").Says On Sept. 30, the US Court of Appeals for the Federal Circuit ("CAFC") lifted a temporary injunction against Hanmi's US launch. AstraZeneca's appeal of the lower court's Dec. 2012 claim construction remains pending. A decision is expected from the CAFC in early 2014.Says depending on the outcome of the appeal, Hanmi's sales are at risk of owing AstraZeneca patent infringement damages. AstraZeneca's appeal concerns both patents-at-issue in the patent-infringement litigation against Hanmi (US Patent Nos. 5,714,504 and 5,877,192).Says there is no impact on AstraZeneca's full year 2013 financial guidance as a result of these developments. 

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24 Dec 2014