Teva has high hopes for its tardive dyskinesia (TD) treatment Austedo. Now, the company has one less generic drug maker to worry about as a threat to its core growth driver.
Monday, Teva revealed that it has agreed to a settlement with Lupin that will allow the Mumbai-based generics manufacturer to sell its version of Austedo in the U.S. beginning in April 2033.
Last July in federal court in New Jersey, Teva filed separate suits against Lupin and another Indian drugmaker, Aurobindo, over their planned generics.
Both companies had notified Teva of their intention to file abbreviated new drug applications with the FDA. In both suits, Teva cited multiple patents it owns on Austedo.
The suit with Hyderabad-based Aurobindo remains unresolved, Teva said. When it filed the complaints last year, Teva said it had tried unsuccessfully to review both generic makers' FDA filings.
Meanwhile, two months ago, the U.S. Patent Office Patent Trial and Appeal Board turned down a request by Apotex to review Teva’s compound patent on the medicine.
Austedo won FDA approval in 2017 as the first product to treat both TD and chorea associated with Huntingdon’s disease. TD and chorea are conditions that cause involuntary jerky movements, mostly in the shoulders, hips and face. In TD, the condition is triggered by antipsychotic treatments such as those for schizophrenia and bipolar disorder.
Teva is counting on Austedo and migraine prevention treatment Ajovy to deliver sales growth as other parts of its business struggle from pricing pressures. In 2021, Austedo generated $802 million in sales, a 26% increase from the prior year.