Benzinga | Mar 25, 2021 09:16AM EDT

RedHill Biopharma Reports Settlement Of Movantik Patent Litigation With MSN Pharma

RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik(r) (naloxegol).

RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.

The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to MSN. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with MSN does not end RedHill's ongoing litigation against the other two ANDA filers.