RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Aurobindo

https://finance.yahoo.com/news/redhill-biopharma-announces-settlement-movantik-110000120.html

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 Hatch-Waxman Act)

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

TEL AVIV, Israel and RALEIGH, N.C., Sept. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today 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.

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 Aurobindo. 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. Upon entry of the stipulation and order of dismissal, this settlement agreement will conclude all Hatch-Waxman Act patent litigation brought to date against ANDA filers prior to the expiration of the patents listed in the Orange Book.