Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., U.S. affiliates of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have reached an agreement with Aurobindo to resolve the dispute over Aurobindo's Abbreviated New Drug Application ("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.
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.
AUSTEDO 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.
Teva 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.