BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.
Amneal will acquire rights to Hanmi's regulatory approval application for esomeprazole strontium delayed-release capsules. The application was filed with the Food and Drug Administration and included bioequivalence testing against AstraZeneca's Nexium (esomeprazole magnesium) delayed-release capsules. The company's expect the FDA to decide whether or not to approve the drug in April 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," Amneal president Chirag Patel said.