A US appeals court has issued a temporary injunction against South Korea’s Hanmi Pharmaceutical Co, preventing the launch of a drug described as an alternative to AstraZeneca’s stomach acid blockbuster Nexium.
The treatment in question is Esomezol (esomeprazole strontium) which was filed with the US Food and Drug Administration in October 2010 and the data filed included comparative bioequivalence testing against Nexium (esomeprazole magnesium). In August, Hanmi and partner Amneal Pharmaceuticals of the USA received tentative approval from the agency for Esomezol.
Hanmi and Amneal are looking to get their product onto the US market this year, prior to the expected entry of generic versions of Nexium next year. However, the injunction is now in place and Hanmi has a week to respond.
In June, AstraZeneca entered into an agreement with Hanmi and Amneal to “streamline litigation issues” regarding Esomezol, whereby the latter two conceded the validity and enforceability of a couple of patents that protect Nexium. The Anglo-Swedish drugmaker then filed an appeal in July concerning an earlier judgement in December 2012.