AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole strontium product.
US court paves way for Nexium competition
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Posted 18/10/2013
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South Korea-based Hanmi received FDA approval for its new drug application (NDA) of esomeprazole strontium product on 6 August 2013. However, AstraZeneca’s blockbuster stomach acid relief drug, Nexium (esomeprazole), is only set to lose patent protection in the US in 2014.
Although Hanmi’s product is not chemically identical to Nexium, and would not be automatically substitutable for Nexium at pharmacies, the UK-based drugmaker has accused Hanmi of patent infringement.
The US Court of Appeals for the Federal Circuit initially issued a temporary injunction against the US launch of Hanmi’s NDA for esomeprazole strontium on 13 September 2013, but has now reversed that decision. AstraZeneca has litigation ongoing in the US District Court of New Jersey.
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Source: AstraZeneca, Reuters
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