Teva and Auspex Pharmaceuticals, U.S. affiliates of Teva Pharmaceutical, have reached an agreement with Aurobindo to resolve the dispute over Aurobindo’s ANDA for a generic deutetrabenazine product.
Teva and Aurobindo have been involved in a patent infringement litigation in which Teva asserted a number of patents against Aurobindo that cover Teva’s Austedo (deutetrabenazine) product.
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Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Aurobindo will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances.
Aaustedo is the first and only FDA-approved product indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia, or TD.
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TD is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact individuals. Safety and effectiveness in pediatric patients have not been established.
Teva said that it believes that today’s settlement with Aurobindo is a further reflection of the strength of its intellectual property covering its Austedo product. On March 9, 2022, the U.S. Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex.