The generic approval date for tetrabenazine can vary depending on the specific manufacturer seeking approval. Tetrabenazine is marketed under the brand name Xenazine.
When does Xenazine (tetrabenazine) patent exclusivity expire?
The primary patent for tetrabenazine, US Patent No. 7,371,752, expired in December 2023 [1]. This patent covered the use of tetrabenazine for treating chorea associated with Huntington's disease [1].
Can generic tetrabenazine be approved before patent expiry?
The U.S. Food and Drug Administration (FDA) can approve generic drugs before the expiration of brand-name drug patents under certain circumstances, such as if the patent is successfully challenged in court or if the patent holder has not taken steps to defend it [2].
Who makes generic tetrabenazine?
Multiple pharmaceutical companies have sought and obtained FDA approval for generic versions of tetrabenazine. For example, Teva Pharmaceuticals received tentative approval for its generic tetrabenazine extended-release oral suspension [3]. Information on other manufacturers and their approved products can be found on the FDA's Orange Book [4].
What are the indications for tetrabenazine?
Tetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It is primarily indicated for the treatment of chorea associated with Huntington's disease [5].
What is the mechanism of action for tetrabenazine?
Tetrabenazine works by depleting monoamines like dopamine in the brain [5]. By inhibiting VMAT2, it interferes with the transport of monoamines into storage vesicles, leading to a reduction in their release and turnover [5]. This mechanism is believed to be responsible for its effect in reducing involuntary movements.
What are the risks and side effects of tetrabenazine?
Tetrabenazine carries a boxed warning for depression and suicidality [5]. Patients taking tetrabenazine may experience depression, suicidal thoughts, and behavioral changes. It is also associated with other potential side effects, including somnolence, parkinsonism, and akathisia [5].
How does tetrabenazine compare to other Huntington's disease treatments?
While tetrabenazine is a primary treatment for chorea in Huntington's disease, other therapeutic approaches and medications may be considered depending on the patient's specific symptoms and overall health [6]. Research into novel treatments for Huntington's disease is ongoing [7].
Sources:
1. DrugPatentWatch.com. (n.d.). Xenazine U.S. Patent Status. https://drugpatentwatch.com/
2. U.S. Food and Drug Administration. (2022). ANDA Approval Letters. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/anda-approval-letters
3. Teva Pharmaceuticals. (2019, July 29). TEVA ANNOUNCES FINAL FDA APPROVAL FOR FIRST GENERIC VERSION OF XENAZINE® (TETRABENAZINE) EXTENDED-RELEASE ORAL SUSPENSION. https://www.tevapharm.com/news/teva-announces-final-fda-approval-for-first-generic-version-of-xenazine-tetrabenazine-extended-release-oral-suspension/
4. U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
5. U.S. Food and Drug Administration. (2008, August 27). FDA Approves Xenazine. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-xenazine
6. National Institute of Neurological Disorders and Stroke. (n.d.). Huntington's Disease Information Page. https://www.ninds.nih.gov/Disorders/All-Disorders/Huntingtons-Disease-Information-Page
7. Huntington's Disease Society of America. (n.d.). Research. https://www.hdsa.org/research