The U.S. Food and Drug Administration (FDA) has approved a generic version of valbenazine capsules, a medication used to treat tardive dyskinesia [1]. This approval marks a significant development for patients seeking more affordable treatment options for this movement disorder [2].
When does the brand-name drug exclusivity expire?
The original brand-name drug, Ingrezza, developed by Neurocrine Biosciences, has faced patent challenges. Information on specific patent expiry dates and ongoing litigation can be complex, but the approval of generics indicates that key market exclusivities have ended or are nearing their end. DrugPatentWatch.com tracks these patent landscapes and potential generic entry timelines [3].
Who is manufacturing the generic valbenazine?
Lupin Pharmaceuticals Inc. has received FDA approval for its generic valbenazine capsules [1]. This signifies Lupin's entry into the market for this tardive dyskinesia treatment.
What is tardive dyskinesia and how does valbenazine work?
Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements. Valbenazine works by selectively inhibiting vesicular monoamine transporter 2 (VMAT2), which helps to reduce the abnormal movements associated with the condition [4].
What is the difference between brand-name and generic drugs?
Generic drugs, like the newly approved valbenazine capsules, are required to be therapeutically equivalent to their brand-name counterparts. This means they contain the same active ingredient, dosage form, strength, and route of administration, and are expected to have the same clinical effect and safety profile [5]. The primary difference is typically the cost, with generics generally being more affordable [2].
What are the potential risks or side effects associated with valbenazine?
While generally considered safe and effective, both brand-name and generic valbenazine carry potential side effects. Common side effects can include somnolence and Parkinsonism. More serious concerns, though less common, may involve the risk of QT prolongation [4]. Patients should discuss any potential risks and side effects with their healthcare provider.