Amneal Pharmaceuticals, Hanmi Pharmaceutical, AstraZeneca generics, gastrointestinal news
The companies entered into a consent judgment to resolve aspects of ongoing litigation regarding two patents covering Nexium esomeprazole from AstraZeneca. Under the terms of the consent judgment, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca's U.S. Patent Nos. 5,714,504 and 5,877,192. The judgment also provides that a generic from Hanmi does not infringe on those patents; AstraZeneca said it would seek to reverse the claim on appeal. Hanmi may pursue an "at-risk launch" of its product if approved, though AstraZeneca retains its right to seek injunctive relief from the U.S. Court of Appeals for the Federal Circuit. Amneal declined to comment on the status of the esomeprazole NDA, which had an April 29 PDUFA date. ...