AstraZeneca issued a statement regarding the launch of esomeprazole strontium in the United States by Seoul, South Korea-based Hanmi Pharmaceutical and its US marketing partner Amneal Pharmaceuticals.
Amneal Pharmaceuticals reported that the first shipping of esomeprazole strontium was made to three major US pharmaceutical wholesalers on Dec. 18, 2013. Esomeprazole strontium contains the same active moiety (esomeprazole) in a different salt form as found in AstraZeneca's branded proton-pump inhibitor Nexium (esomeprazole magnesium) and is used to treat adult patients for the short term treatment of gastroesophageal reflux disease (GERD). Hanmi Pharmaceutical received FDA approval for esomeprazole strontium delayed-release capsules for oral use in August 2013. AstraZeneca's Nexium had 2012 sales of $3.9 billion.
In a press statement, AstraZeneca said that it "is aware of reports that an 505(b)(2) NDA esomeprazole strontium product has been launched in the US by Hanmi Pharmaceutical and affiliates (Hanmi) and its US marketing partner Amneal Pharmaceuticals (Amneal).
AstraZeneca said that on Sept. 30, 2013, the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against Hanmi’s US launch of its 505(b)(2) NDA esomeprazole strontium product (previously granted on Sept. 13, 2013). AstraZeneca’s appeal of the lower court’s December 2012 claim construction remains pending. After oral argument on Nov. 18, 2013, a decision is expected from the CAFC in early 2014.
"Depending on the outcome of the appeal, Hanmi's sales are at risk of owing AstraZeneca patent-infringement damages," said AstraZeneca in its statement. "AstraZeneca’s appeal concerns both patents-at-issue in the patent-infringement litigation against Hanmi (US Patent Nos. 5,714,504 and 5,877,192). AstraZeneca understands that Hanmi’s 505(b)(2) NDA esomeprazole strontium product is not AB-rated and is not automatically substitutable for Nexium."
AstraZeneca said that the developments have no impact on AstraZeneca’s full-year 2013 financial guidance.