AstraZeneca statement in response to reports of a launch of esomeprazole strontium product in the US

AstraZeneca is aware of reports that an 505(b)(2) NDA esomeprazole strontium product has been launched in the US by Hanmi Pharmaceutical and affiliates (“Hanmi”) and its US marketing partner Amneal Pharmaceuticals (“Amneal”).

On 30 September 2013, the US Court of Appeals for the Federal Circuit (“CAFC”) lifted a temporary injunction against Hanmi’s US launch of its 505(b)(2) NDA esomeprazole strontium product (previously granted on 13 September 2013). AstraZeneca’s appeal of the lower court’s December 2012 claim construction remains pending. After oral argument on 18 November 2013, a decision is expected from the CAFC in early 2014.

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).

AstraZeneca understands that Hanmi’s 505(b)(2) NDA esomeprazole strontium product is not AB-rated and is not automatically substitutable for Nexium.

There is no impact on AstraZeneca’s full year 2013 financial guidance as a result of these developments.