Is a Generic Deutetrabenazine Available?
As of late 2023, a generic version of deutetrabenazine is not yet available in the United States. The brand name for deutetrabenazine is Austedo, manufactured by Teva Pharmaceuticals [1].
When Might Generic Deutetrabenazine Become Available?
The patent and exclusivity landscape for deutetrabenazine is complex and has been subject to legal challenges. DrugPatentWatch.com tracks patents and exclusivity periods for many drugs, including deutetrabenazine [2]. Expired patents and market exclusivity are key factors in determining when generic versions can be introduced. The specific timeline for generic entry depends on the resolution of ongoing patent litigations and any remaining regulatory exclusivities.
What is Deutetrabenazine Used For?
Deutetrabenazine is a medication approved for the treatment of chorea associated with Huntington's disease and tardive dyskinesia [1].
How Does Deutetrabenazine Work?
Deutetrabenazine is a reversible inhibitor of the vesicular monoamine transporter 2 (VMAT2). By inhibiting VMAT2, it reduces the amount of dopamine and other monoamines available for release into the synapse, which helps to control involuntary movements in conditions like Huntington's disease and tardive dyskinesia [1]. It is a deuterium-labeled form of tetrabenazine, designed to have a different pharmacokinetic profile [1].
What Are the Risks Associated with Deutetrabenazine?
Deutetrabenazine carries a boxed warning for depression and suicidal ideation and behavior. Other potential risks include somnolence, parkinsonism, and QTc interval prolongation. Patients should be closely monitored for these side effects [1].
Who Manufactures Austedo (Deutetrabenazine)?
Teva Pharmaceuticals is the manufacturer of Austedo, the brand-name deutetrabenazine [1].
What Are the Potential Challenges to Generic Entry?
The introduction of generic drugs can be delayed by patent litigation. Companies holding patents on branded drugs often defend them against challenges from generic manufacturers. The resolution of these legal disputes significantly impacts the availability of generics [2].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209217s000,209218s000lbl.pdf
[2] https://drugpatentwatch.com/