RedHill Biopharma Ltd. (RDHL), a specialty biopharmaceutical company, on Thursday, said RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP, and Nektar Therapeutics have entered into a settlement and license deal with Aurobindo Pharma USA, Inc. to resolve their patent litigation in the U.S.
The latest move of the companies has come in response to Aurobindo's Abbreviated New Drug Application (ANDA) seeking approval by the U.S. Food and Drug Administration to market a generic version of Movantik (naloxegol).
RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.
As per the terms of the settlement deal, 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 is expected to 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," the company revealed.
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