Generic heartburn drug made by Korean company poised to win FDA approval

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

The companies said a consent judgment had been entered by the U.S. District Court for the District of New Jersey in a patent litigation suit that AstraZeneca filed in February 2011, alleging that Hanmi infringed its patent on Nexium (esomeprazole-strontium) delayed-release capsules. The judgment states that Hanmi has acknowledged two patents in the case as enforceable and valid, and that Hanmi's product does not infringe the claims of the two patents based on a December 2012 ruling by the court.

The Food and Drug Administration gave tentative approval to the generic drug at the end of April, and Hanmi and Amneal expect that it will receive final FDA approval soon. FDA approval would make Hanmi the first Korean company to enter the U.S. generic drug market.