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Teva To Settle Austedo Patent Dispute With Aurobindo

Teva Pharmaceutical Industries Ltd. (TEVA) said that it has reached an agreement with Aurobindo to resolve the dispute over Aurobindo's Abbreviated New Drug Application or "ANDA" for a generic deutetrabenazine product.

The companies 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.

As per 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.

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.

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