Prescription medicine
Valbenazine Brand names: Ingrezza
Valbenazine (Ingrezza) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $283.32 per Ingrezza 80 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the valbenazine FDA label on DailyMed (effective April 17, 2026, Neurocrine Biosciences, Inc.); the NDA 209241 record on Drugs@FDA; every valbenazine label on DailyMed.
Highlights of the record
FDA label of April 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE.
VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageINGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )].
Forms and strengths
- 40 mg
- 60 mg
- 80 mg
Capsule; kit.
On the market
- Earliest approval on file
- April 11, 2017 Ingrezza, Neurocrine; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first April 5, 2024; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 10, 2040 Ingrezza capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $283.32 per capsule Ingrezza 80 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 25,010 through July 30, 2026
What is valbenazine used for?
From the label: indications and usageINGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )]. - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )]. INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. ( 1 ) - chorea associated with Huntington’s disease.
FDA pharmacologic class: Vesicular Monoamine Transporter 2 Inhibitor.
Source: FDA drug label (INGREZZA), Neurocrine Biosciences, Inc., effective April 17, 2026 (SPL set 4c970164-cafb-421f-9eb5-c226ef0a3417), via openFDA; the full label on DailyMed
What does the patient leaflet for valbenazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about INGREZZA or INGREZZA SPRINKLE ?INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington’s disease, including: ◦ depression ◦ suicidal thoughts ◦ suicidal actions Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you: feel sad or have crying spells lose interest in seeing your friends or doing things you used to enjoy sleep a lot more or a lot less than usual feel unimportant feel guilty feel hopeless or helpless feel more irritable, angry or aggressive than usual feel more or less hungry than usual or notice a big change in your body weight have trouble paying attention feel tired or sleepy all the time have thoughts about hurting yourself or ending your life
From the patient leaflet: What should I avoid while taking INGREZZA or INGREZZA SPRINKLE ?Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you because INGREZZA or INGREZZA SPRINKLE can cause sleepiness and tiredness that could cause slow reaction times. Drinking alcohol and taking other medicines that may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE may increase any sleepiness caused by INGREZZA or INGREZZA SPRINKLE.
From the patient leaflet: How should I store INGREZZA or INGREZZA SPRINKLE ?Store INGREZZA at 59°F to 86°F (15°C to 30°C). Store INGREZZA SPRINKLE between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed to protect INGREZZA SPRINKLE from moisture. INGREZZA SPRINKLE granules added to soft food can be stored for up to 2 hours at room temperature between 68°F to 77°F (20°C to 25°C). After 2 hours, throw away any unused portion. Keep INGREZZA , INGREZZA SPRINKLE and all medicines out of the reach of children.
Source: FDA drug label (INGREZZA), Neurocrine Biosciences, Inc., effective April 17, 2026 (SPL set 4c970164-cafb-421f-9eb5-c226ef0a3417), via openFDA; the full label on DailyMed
Is there a generic for valbenazine (Ingrezza)?
The FDA approved the first generic valbenazine on April 5, 2024. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 22 patents for Ingrezza capsules: the compound patent runs to December 22, 2036, and the last listed entry to August 10, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2024 first generic approved
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for valbenazine (Ingrezza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $283.32 per Ingrezza 80 mg capsule, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ingrezza 40 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ingrezza 40 mg capsule | Brand | $258.94 per capsule | $7,768.25 | -0.1% |
| Ingrezza 60 mg capsule | Brand | $283.32 per capsule | $8,499.72 | no change |
| Ingrezza 80 mg capsule | Brand | $283.32 per capsule | $8,499.72 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the valbenazine label say about other medicines?
The valbenazine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name valbenazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Digoxin Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with digoxin increased digoxin levels because of inhibition of intestinal P-glycoprotein (P-gp) [see Clinical Pharmacology ()]. … |
Other labels that name valbenazine
Source: FDA drug label (INGREZZA), Neurocrine Biosciences, Inc., effective April 17, 2026 (SPL set 4c970164-cafb-421f-9eb5-c226ef0a3417), via openFDA; the full label on DailyMed
What do FAERS reports show for valbenazine?
The FDA Adverse Event Reporting System holds 25,010 reports that list valbenazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,295 are coded as a death and 3,493 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2021 (6,279, against a median of 1,200 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other vesicular monoamine transporter 2 inhibitors
- the pharmacologic class, with prices and generics
- Valbenazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other