US Appeals Court lifts temporary injunction on Hanmi Nexium generic NDA
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today (October 2) said that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of South Korea-based Hanmi Pharmaceutical's 505(b)2 NDA Esomezol esomeprazole strontium) product, a copy version of the UK-based firm’s Nexium (esomeprazolemagnesium).
AstraZeneca’s CAFC appeal of claim construction from the US District Court for the District of New Jersey remains ongoing, with briefing to be completed by October 18, and oral argument scheduled in the next months.
On September 13, the US CAFC issued a temporary injunction against the US launch of Hanmi's NDA esomeprazole product. This followed an earlier agreement between AstraZeneca, Hanmi and Amneal to streamline litigation issues regarding Hanmi’s proposed esomeprazole product in June.
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