Tuesday, 17 December 2013
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.
NOTES FOR EDITORS
About the underlying litigation
In June 2013, AstraZeneca entered into an agreement with Hanmi and Amneal to streamline litigation issues regarding Hanmi’s proposed 505(b)(2) NDA esomeprazole strontium product.
Under terms of the agreement, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca’s US Patent Nos. 5,714,504 and 5,877,192 that protect Nexium. The US District Court for the District of New Jersey (“District Court”) entered a Consent Judgment.
In July 2013, AstraZeneca filed a Notice of Appeal in the US CAFC regarding critical aspects of the District Court’s December 2012 claim construction. Among issues, AstraZeneca is seeking a reversal of claim construction.
On 6 August, Hanmi received US FDA approval for its 505(b)(2) NDA esomeprazole strontium product.
On 13 September, the US CAFC issued a temporary injunction against the US launch of Hanmi's 505(b)(2) NDA esomeprazole strontium product.
On 30 September 2013, the US Court of Appeals for the US 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 is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
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