Teva Pharmaceutical Industries Ltd (NYSE: TEVA) inches down in pre trading session on Thursday as the U.S. court appeal filed by the Belgian biopharmaceutical company UCB on Wednesday was denied, making it easier for Mylan Technologies Inc. and Actavis Laboratories UT Inc. of Teva and Actavis to market generic versions of the Parkinson’s disease treatment Neupro.
The Neupro patch patent held by UCB was found to be invalid by the United States Court of Appeals for the Federal Circuit. The U.S. Food and Drug Administration’s licensing of a generic Neupro may have been postponed if the court ruled in favor of UCB until it ran out in December 2030, the court stated.
The intended generic drug by Actavis had been delayed until 2021 by an earlier court ruling based on a different patent.
A Teva representative expressed the company’s satisfaction with the choice. Requests for comment from UCB and Viatris representatives were not immediately fulfilled. Neupro was initially given FDA approval in 2007 to treat Parkinson’s disease, a neurological condition. Due to dosage issues, it was taken off the market in 2008 and reapproved with a new formula in 2012.
According to a business release, UCB sold the medicine for more than 300 million Euros last year.
Actavis and Mylan were sued for patent infringement about their upcoming Neupro generics in 2019 by UCB and LTS Lohmann Therapie-Systeme AG. Based on their prior patents for the first iteration of Neupro, which the court said encompassed the same concept, UCB and LTS’ patent was invalidated by a Delaware court in 2021.
The patent that UCB accused Actavis and Mylan of violating was apparent and not patentable, the Federal Circuit said on Wednesday. Actavis Laboratories UT Inc. v. UCB Inc., No. 21-1924, U.S. Court of Appeals for the Federal Circuit.
Development in Neurology Portfolio
Six poster abstracts from Teva Pharmaceuticals’ range of neurology products will be presented at the American Academy of Neurology (AAN) Annual Meeting from April 22–27, 2023, the company stated. Data for AUSTEDO (deutetrabenazine) tablets and AUSTEDO XR (deutetrabenazine) once-daily extended-release tablets are included in the abstracts. With or without meals, AUSTEDO XR, a once-daily version of AUSTEDO for people with tardive dyskinesia (TD) and chorea linked to Huntington’s disease (HD), has just received FDA approval. It is anticipated to get marketed later this year.
According to Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer of Teva, Much of the data they’re presenting served as a foundation for the FDA’s recent approval of AUSTEDO XR.” They’re thrilled that AUSTEDO XR will provide doctors the chance to learn more about its potential as a once-daily treatment option that can provide adults with TD and HD chorea with the same therapeutic effect as twice-daily AUSTEDO.
