Austedo is a medication used to treat chorea associated with Huntington's disease and tardive dyskinesia [1][2]. Its active ingredients are deutetrabenazine [1].
What is deutetrabenazine and how does Austedo work?
Deutetrabenazine is a form of tetrabenazine that has been modified with deuterium [1]. This deuterium substitution slows the metabolism of the drug in the body, potentially leading to more stable drug levels and a reduced need for frequent dosing compared to other formulations [1][3]. Austedo works by inhibiting vesicular monoamine transporter 2 (VMAT2), which plays a role in regulating neurotransmitters like dopamine [1]. By reducing dopamine levels in the brain, it can help manage the involuntary movements characteristic of Huntington's disease and tardive dyskinesia [1].
When does Austedo's patent exclusivity expire?
The patent exclusivity for Austedo is a complex area with multiple patents and potential challenges. Information on specific patent expiry dates and potential litigation can be found through resources like DrugPatentWatch.com [4]. Generally, new drug patents can last up to 20 years from the filing date, but extensions and exclusivities related to regulatory reviews can alter the effective market protection period.
Who are Austedo's competitors?
Other medications are available for treating chorea associated with Huntington's disease and tardive dyskinesia. Tetrabenazine (Xenazine) is a related drug that also inhibits VMAT2. The development of deutetrabenazine in Austedo was intended to offer potential advantages over existing treatments [3]. Additionally, other therapeutic approaches and investigational drugs are being explored for these conditions.
What are the potential risks and side effects of Austedo?
Austedo carries a boxed warning regarding the risk of depression and suicidal thoughts or behaviors. Patients should be monitored for these symptoms, and the drug should be discontinued if they occur. Other potential side effects include somnolence, parkinsonism, and akathisia. It is also contraindicated in patients with uncontrolled hypertension and in those taking monoamine oxidase inhibitors (MAOIs) [1].
Can generic versions of Austedo become available?
The availability of generic versions of Austedo, or biosimilars in the case of biologics, depends on the expiry of relevant patents and any successful patent challenges. Regulatory bodies like the FDA oversee the approval of generic drugs, which must demonstrate bioequivalence to the branded product. Information on the patent landscape and potential for generic entry is often tracked by specialized services [4].