Amneal Pharmaceuticals, LLC today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., Ltd to acquire exclusive distribution rights to Hanmi's new drug application (NDA), currently under FDA review, for esomeprazole strontium delayed-release capsules. Hanmi's NDA was filed with the U.S. FDA pursuant to Section 505(b)(2) of the Food, Drug and Cosmetic Act including comparative bioequivalence testing against AstraZeneca's Nexium® (esomeprazole magnesium delayed-release capsules). Originally submitted to the FDA in October 2010 with additional development data subsequently provided by Hanmi, the NDA has been granted a revised Prescription Drug User Fee Act (PDUFA) date of April 29, 2013.
"We are very excited to enter into this partnership with Hanmi, as it gives Amneal the opportunity to introduce a high quality, low cost esomeprazole strontium product into the U.S. market, potentially before other generic competitors," said Chirag Patel, President of Amneal. Amneal expects the product to obtain timely FDA approval, and subject to the favorable resolution of ongoing litigation between Hanmi and AstraZeneca, Amneal anticipates a potential commercial launch in 2013, prior to the expected entry of generic versions of Nexium®.
Amneal Pharmaceuticals, LLC