Teva Announces Settlement with Aurobindo Resolving AUSTEDO (deutetrabenazine) Patent Dispute

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.

About AUSTEDO (deutetrabenazine) Tablets

AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. 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.

Indications and Usage

AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.