Prescription medicine
Lumateperone Brand names: Caplyta
Lumateperone (Caplyta) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $57.24 per Caplyta 10.5 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the lumateperone FDA label on DailyMed (effective June 20, 2025, Intra-Cellular Therapies, Inc); the NDA 209500 record on Drugs@FDA; every lumateperone label on DailyMed.
Highlights of the record
FDA label of June 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2) ]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. […]
Used for
From the label: indications and usageCAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ].
Forms and strengths
- 10.5 mg
- 21 mg
- 42 mg
Capsule.
On the market
- Earliest approval on file
- December 20, 2019 Caplyta, Intra-Cellular; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 10, 2040 Caplyta capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $57.24 per capsule Caplyta 10.5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,088 through July 30, 2026
What is lumateperone used for?
From the label: indications and usageCAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ]. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ]. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. […]
Conditions named in the indications of lumateperone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (CAPLYTA), Intra-Cellular Therapies, Inc, effective June 20, 2025 (SPL set db730b06-6351-47fd-8183-e61e61bbead5), via openFDA; the full label on DailyMed
What does the patient leaflet for lumateperone 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 CAPLYTA?CAPLYTA may cause serious side effects, including: Increased risk of death in elderly people with dementia related psychosis. Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts and actions. CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or the antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking CAPLYTA?Do not drive, operate machinery, or do other dangerous activities until you know how CAPLYTA affects you. CAPLYTA may make you drowsy. Do not become too hot or dehydrated during treatment with CAPLYTA. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
From the patient leaflet: How should I store CAPLYTA?Store CAPLYTA at room temperature between 68°F to 77°F (20°C to 25°C). Keep CAPLYTA and all medicines out of the reach of children.
Source: FDA drug label (CAPLYTA), Intra-Cellular Therapies, Inc, effective June 20, 2025 (SPL set db730b06-6351-47fd-8183-e61e61bbead5), via openFDA; the full label on DailyMed
Is there a generic for lumateperone (Caplyta)?
No generic lumateperone is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 25 patents for Caplyta capsules: the compound patent runs to December 1, 2029, and the last listed entry to December 10, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 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 lumateperone (Caplyta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $57.24 per Caplyta 10.5 mg capsule, up 5% from $54.66 on October 8, 2025. 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.
- Caplyta 21 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Caplyta 10.5 mg capsule | Brand | $57.24 per capsule | $1,717.29 | +5% |
| Caplyta 21 mg capsule | Brand | $57.20 per capsule | $1,716.01 | +5% |
| Caplyta 42 mg capsule | Brand | $57.25 per capsule | $1,717.41 | +5% |
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 lumateperone label say about other medicines?
The lumateperone label names no other medicine on this site. The labels of 1 other medicine name lumateperone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name lumateperone
Source: FDA drug label (CAPLYTA), Intra-Cellular Therapies, Inc, effective June 20, 2025 (SPL set db730b06-6351-47fd-8183-e61e61bbead5), via openFDA; the full label on DailyMed
What do FAERS reports show for lumateperone?
The FDA Adverse Event Reporting System holds 7,088 reports that list lumateperone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 61 are coded as a death and 569 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 2024 (1,997, against a median of 170 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 else is labeled for the same conditions as lumateperone?
21 other medicines are given the same way (oral) and in the same FDA class as lumateperone or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Depression, Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as lumateperone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lumateperone
- 21 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Lumateperone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other