Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., U.S. affiliates of Teva Pharmaceutical Industries Ltd., have reached an agreement with Lupin to resolve the dispute over Lupin’s Abbreviated New Drug Application (“ANDA") for a generic deutetrabenazine product. Teva and Lupin have been involved in a patent infringement litigation in which Teva asserted a number of patents against Lupin 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 Lupin 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 to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease.
Teva believes that today’s settlement with Lupin 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. Teva will continue to litigate the ongoing patent infringement suit it brought against Aurobindo regarding Aurobindo’s ANDA for a generic deutetrabenazine product.
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