See the DrugPatentWatch profile for Ingrezza
What are the main treatments for tardive dyskinesia?
The primary treatment for tardive dyskinesia (TD) is vesicular monoamine transporter 2 (VMAT2) inhibitors. The Food and Drug Administration (FDA) has approved two VMAT2 inhibitors for the treatment of TD: Ingrezza (valbenazine) and Austedo (deutetrabenazine) [1][2]. These medications work by reducing the amount of dopamine released in the brain, which can help to control involuntary movements associated with TD [2].
How does Ingrezza work for tardive dyskinesia?
Ingrezza, with the active ingredient valbenazine, is a VMAT2 inhibitor. It selectively targets VMAT2, an enzyme responsible for packaging monoamines like dopamine into vesicles for release. By inhibiting VMAT2, Ingrezza reduces the storage and release of dopamine in the brain. This modulation of dopamine levels is believed to alleviate the involuntary movements characteristic of tardive dyskinesia [1].
What is the difference between Ingrezza and Austedo?
Both Ingrezza (valbenazine) and Austedo (deutetrabenazine) are VMAT2 inhibitors approved for tardive dyskinesia and chorea associated with Huntington's disease. Austedo is a deuterated version of tetrabenazine, a VMAT2 inhibitor that has been used off-label for TD. Deuteration involves replacing certain hydrogen atoms with deuterium atoms, which can alter the drug's metabolism and potentially lead to a different dosing profile or side effect profile compared to its non-deuterated counterpart [1][2]. The choice between Ingrezza and Austedo often depends on individual patient factors, physician preference, and response to treatment [1][2].
What other options are available for tardive dyskinesia?
Beyond the approved VMAT2 inhibitors, other treatment approaches for tardive dyskinesia may be considered. These can include discontinuing or reducing the dose of the offending medication that caused TD, though this is not always feasible or effective. In some cases, other medications might be tried, although their efficacy for TD is less established than that of VMAT2 inhibitors. Management also often involves supportive care and therapy to help patients cope with the condition [1][2].
When does Ingrezza's patent expire?
The patent landscape for Ingrezza is complex and includes multiple patents covering its composition, formulation, and methods of use. According to DrugPatentWatch.com, the earliest expected expiry for a key patent related to Ingrezza is in 2037 [3]. However, patent expiry dates can be subject to legal challenges, extensions, and additional patent filings, which may affect the actual market exclusivity duration [3].
What is the typical cost of Ingrezza?
The cost of Ingrezza can vary significantly depending on insurance coverage, pharmacy, and dosage. Without insurance, the retail price can be several thousand dollars per month. Patient assistance programs and insurance co-pay cards may be available from the manufacturer to help offset these costs for eligible individuals [1].
What are the potential side effects of Ingrezza?
Common side effects associated with Ingrezza include somnolence and the risk of QT interval prolongation. Somnolence, or sleepiness, is a frequent concern for patients taking Ingrezza. The risk of QT interval prolongation, which can affect heart rhythm, necessitates caution, particularly in patients with pre-existing cardiac conditions or those taking other medications that prolong the QT interval. Healthcare providers monitor patients for these and other potential adverse effects [1].
How effective are Ingrezza and Austedo in clinical trials?
Clinical trials for Ingrezza have demonstrated statistically significant reductions in abnormal involuntary movement scores in patients with tardive dyskinesia compared to placebo. Similarly, Austedo has also shown efficacy in reducing the severity of TD in clinical studies. The magnitude of benefit can vary between individuals, and ongoing monitoring is essential to assess treatment effectiveness [1][2].