23 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US Court of Appeals for the Federal Circuit has issued a temporary injunction against the US launch of South Korea-based Hanmi's 505(b)2 new drug application (NDA) esomeprazole strontium product.
In June 2013, AstraZeneca entered into an agreement with Hanmi Pharmaceutical and affiliates and Amneal Pharmaceuticals 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 numbers 5,714,504 and 5,877,192 that protect Nexium. The US District Court for the District of New Jersey will enter a consent judgment.
In July 2013, AstraZeneca filed a notice of appeal in the US Court of Appeals for the Federal Circuit regarding critical aspects of the District Court's December 2012 construction. Among issues, AstraZeneca is seeking a reversal of claim construction.
South Korea-based Hanmi Pharmaceuticals received US FDA approval for esomeprazole strontium on August 6, 2013.