The U.S. Food and Drug Administration (FDA) approved Ingrezza (valbenazine) capsules for extended-release on May 20, 2024 [1].
When was the original Ingrezza approved?
The original Ingrezza capsules were approved by the FDA on April 26, 2017 [2]. This initial approval was for the treatment of adults with tardive dyskinesia [2].
What is Ingrezza XR for?
Ingrezza XR is an extended-release formulation of valbenazine. It is approved for the treatment of adults with tardive dyskinesia and also for the treatment of chorea associated with Huntington's disease [1].
How does Ingrezza XR work?
Ingrezza and Ingrezza XR work by selectively inhibiting the vesicular monoamine transporter 2 (VMAT2) [2][1]. VMAT2 is involved in the transport of monoamines, including dopamine, from the cytoplasm into synaptic vesicles. By inhibiting VMAT2, valbenazine is thought to reduce the release of dopamine in the brain, which is believed to be a contributing factor to the involuntary movements seen in tardive dyskinesia and chorea associated with Huntington's disease [2][1].
What is tardive dyskinesia?
Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements. It is often a side effect of long-term use of dopamine-blocking medications, such as antipsychotics [2].
What is chorea associated with Huntington's disease?
Chorea is a symptom of Huntington's disease, a progressive neurodegenerative disorder. It presents as involuntary, irregular, and unpredictable movements that can affect any part of the body [1].
When does Ingrezza's patent expire?
Patent information for Ingrezza can be complex and may involve multiple patents covering the drug substance, formulation, and methods of use. Information regarding specific patent expiry dates for Ingrezza is available through resources that track drug patents [3]. For detailed patent timelines and potential market entry dates for generics or biosimilars, consulting a specialized drug patent database is recommended [3]. DrugPatentWatch.com is a resource that provides such information [3].