Teva Launches Suit Against Aurobindo and Lupin Over Huntington’s Generics
Teva Pharmaceuticals has filed federal lawsuits against Aurobindo and Lupin over their planned generics of its Huntington’s disease drug Austedo (deutetrabenazine).
Teva filed two complaints in the U.S. District Court for the District of New Jersey after it received separate notices from the two Indian drugmakers about their intention to file abbreviated new drug applications (ANDAs) with the FDA.
Teva said it had unsuccessfully sought to review Aurobindo’s ANDA and that the company refused to produce samples of its products and “other internal documents and materials relevant to infringement.” The complaint against Lupin includes similar claims.
The FDA approved Austedo in 2017 for treatment of chorea — a condition associated with Huntington’s disease that involves involuntary jerky movements of the shoulders, hips and face. The drug is also approved for treating tardive diskenesia, another condition involving repetitive, jerking movements in the face, neck and tongue.