RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Aurobindo
RedHill Biopharma Ltd, a specialty biopharmaceutical company, announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ("AstraZeneca") and Nektar Therapeutics have entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. resolving their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).
RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.
Under the terms of the settlement agreement, Aurobindo may not sell a generic version of Movantik in the U.S. until April 1, 2031 (subject to U.S. FDA approval) or earlier under certain circumstances.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!