Consent agreement moves Nexium alternative closer to FDA approval

A federal court in New Jersey has entered a consent judgment regarding the patent infringement litigation between Hanmi Pharmaceuticals (Seoul, Korea) and AstraZeneca (London).

In February of 2011, AstraZeneca filed suit alleging that Hanmi’s proposal to market esomeprazole strontium delayed release capsules infringed two of its patents involving its heartburn drug Nexium.

The consent judgment stipulates that Hanmi acknowledges that AstraZeneca’s two asserted patents are enforceable and valid, and that the Hanmi product does not infringe on them--based on a court ruling issued on December 12, 2013. AstraZeneca has reserved its right to appeal that ruling.

FDA tentatively approved Hanmi’s product on April 30, 2013, and the company anticipates receiving final approval soon. Hanmi’s product would be the first generic product commercialized in the United States that contains the active moiety esomeprazole. Amneal Pharmaceuticals will partner with Hanmi to market the product following FDA approval.