US appeals court issues temporary injunction against Hanmi’s 505(b)2 NDA Esomeprazole Strontium

Friday, 13 September 2013

AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has issued a temporary injunction against the US launch of Hanmi's 505(b)2 NDA Esomeprazole Strontium product.


About the underlying litigation

In June 2013, AstraZeneca entered into an agreement with Hanmi Pharmaceutical and affiliates (“Hanmi”) and Amneal Pharmaceuticals (“Amneal”) to streamline litigation issues regarding Hanmi’s proposed Esomeprazole Strontium 505(b)2 NDA 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”) will enter a Consent Judgment.

In July 2013, AstraZeneca filed a Notice of Appeal in the US Court of Appeals for the Federal Circuit (“Federal Circuit”) regarding critical aspects of the District Court’s December 2012 construction. Among issues, AstraZeneca is seeking a reversal of claim construction.

On 6 August, Hanmi Pharmaceuticals received US FDA approval for Esomeprazole Strontium.

About AstraZeneca

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:


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