RedHill Biopharma Announces Movantik Patent Litigation Settlement With Aurobindo

RedHill Biopharma Ltd. (RDHL), a specialty biopharmaceutical company, announced Thursday the settlement of Movantik patent litigation with Aurobindo Pharma USA, Inc.

The company noted that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP and Nektar Therapeutics have entered into a settlement and license agreement with Aurobindo resolving their patent litigation in the U.S.

This was in response to Aurobindo's Abbreviated New Drug Application or ANDA seeking approval by the US. Food and Drug Administration to market a generic version of Movantik (naloxegol).

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

Under the settlement deal terms, 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.

The settlement agreement with Aurobindo brings closure to all presently pending Movantik patent litigation brought pursuant to The Drug Price Competition and Patent Term Restoration Act.

The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030.

The companies 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 Aurobindo.

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