Prescription medicine
Asenapine Brand names: Saphris, Secuado
Asenapine (Saphris) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $2.63 per tablet (Asenapine 10 mg tablet sl) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the asenapine FDA label on DailyMed (effective January 31, 2025, Allergan, Inc.); the NDA 22117 record on Drugs@FDA; every asenapine label on DailyMed.
Highlights of the record
FDA label of January 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. SAPHRIS ® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1, 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis.
Used for
From the label: indications and usageAN D USAGE SAPHRIS is indicated for: Schizophrenia in adults [see Clinical Studies ( 14.1 )] Bipolar I disorder [see Clinical Studies ( 14.2 )]
Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
Adjunctive treatment to lithium or valproate in adults
Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for ( 1 ): Schizophreni
Forms and strengths
- 2.5 mg
- 3.8 mg
- 5 mg
- 5.7 mg
- 7.6 mg
- 10 mg
Tablet; extended-release film.
On the market
- Earliest approval on file
- August 13, 2009 Saphris, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first December 10, 2020; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 6, 2026 Saphris tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.63 per tablet Asenapine 10 mg tablet sl
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2017 0 Class I among all firms' recalls; latest April 19, 2021
- FAERS reports
- 8,667 through July 30, 2026
What is asenapine used for?
From the label: indications and usageAN D USAGE SAPHRIS is indicated for: Schizophrenia in adults [see Clinical Studies ( 14.1 )] Bipolar I disorder [see Clinical Studies ( 14.2 )]
Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
Adjunctive treatment to lithium or valproate in adults
Maintenance monotherapy treatment in adults SAPHRIS is an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder ○ Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age ○ Adjunctive treatment to lithium or valproate in adults ○ Maintenance monotherapy treatment in adults
Conditions named in the indications of asenapine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (SAPHRIS), NDA022117 (Abbvie), as published by Allergan, Inc., effective January 31, 2025 (SPL set 5429f134-839f-4ffc-9944-55f51238def8), via openFDA; the full label on DailyMed
Is there a generic for asenapine (Saphris)?
The FDA approved the first generic asenapine on December 10, 2020. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists asenapine from 5 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Saphris tablets: the compound patent runs to April 6, 2026 (pediatric exclusivity to October 6, 2026); a patent listed only for Secuado system runs to September 22, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2020 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for asenapine (Saphris)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.63 per tablet (Asenapine 10 mg tablet sl), up 5% from $2.50 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Asenapine 5 mg tablet sl (generic)
- Saphris 2.5 mg tablet sublingual (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Asenapine 10 mg tablet sl | Generic | $2.63 per tablet | $78.82 | +5% |
| Asenapine 2.5 mg tablet sl | Generic | $3.09 per tablet | $92.64 | -2% |
| Asenapine 5 mg tablet sl | Generic | $2.03 per tablet | $60.97 | -9% |
| Saphris 10 mg tablet sublingual | Brand | $21.16 per tablet | $634.78 | +5% |
| Saphris 2.5 mg tablet sublingual | Brand | $20.99 per tablet | $629.83 | +5% |
| Saphris 5 mg tablet sublingual | Brand | $21.16 per tablet | $634.82 | +5% |
| Secuado 3.8 mg/24 hr patch | Brand | $49.07 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
| Secuado 5.7 mg/24 hr patch | Brand | $49.05 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +7% |
| Secuado 7.6 mg/24 hr patch | Brand | $48.83 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has asenapine been recalled?
The FDA's Enforcement Report lists 3 recalls naming asenapine since 2017: 0 Class I (the most serious), 1 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 19, 2021 | Class III | SigmaPharm Laboratories LLC | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent |
| May 18, 2017 | Class II | Forest Laboratories, LLC | Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the asenapine label say about other medicines?
The asenapine label names 23 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Amiodarone | warnings and precautions | The use of SAPHRIS should be avoided in combination with other drugs known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g. … |
| Aripiprazole | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Carbamazepine | drug interactions | Interactions with SAPHRIS No dosage adjustment of SAPHRIS is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions ( 7.1 ) for paroxetine dosage adjustment), imipramine, cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Chlorpromazine | warnings and precautions | The use of SAPHRIS should be avoided in combination with other drugs known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g. … |
| Cimetidine | drug interactions | Interactions with SAPHRIS No dosage adjustment of SAPHRIS is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions ( 7.1 ) for paroxetine dosage adjustment), imipramine, cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Ciprofloxacin | drug interactions | Fluvoxamine, ciprofloxacin, enoxacin CYP2D6 substrates and inhibitors Clinical Implication Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism by CYP2D6. |
| Divalproex | drug interactions | In addition, valproic acid and lithium pre-dose serum concentrations collected from an adjunctive therapy study were comparable between asenapine-treated patients and placebo-treated patients indicating a lack of effect of asenapine on valproic and lithium plasma levels. |
| Fluvoxamine | drug interactions | Strong CYP1A2 Inhibitors (e.g., Fluvoxamine) SAPHRIS is metabolized by CYP1A2. |
| Gatifloxacin | warnings and precautions | … sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin, moxifloxacin). |
| Imipramine | drug interactions | Interactions with SAPHRIS No dosage adjustment of SAPHRIS is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions ( 7.1 ) for paroxetine dosage adjustment), imipramine, cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Lithium | drug interactions | Interactions with SAPHRIS No dosage adjustment of SAPHRIS is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions ( 7.1 ) for paroxetine dosage adjustment), imipramine, cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Moxifloxacin | warnings and precautions | … antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin, moxifloxacin). |
| Olanzapine | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Paroxetine | drug interactions | DRUG INTERACTIONS Antihypertensive Drugs: SAPHRIS may cause hypotension. ( 5.7 , 7.1 , 12.3 ) Paroxetine (CYP2D6 substrate and inhibitor): |
Every other medicine the asenapine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenytoin | drug interactions | … cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Procainamide | warnings and precautions | The use of SAPHRIS should be avoided in combination with other drugs known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g. … |
| Quinidine | warnings and precautions | The use of SAPHRIS should be avoided in combination with other drugs known to prolong QTc including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g. … |
| Rifampin | drug interactions | … valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). |
| Risperidone | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of … |
| Sotalol | warnings and precautions | … quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin … |
| Thioridazine | warnings and precautions | … sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin, moxifloxacin). |
| Valproic acid | drug interactions | In addition, valproic acid and lithium pre-dose serum concentrations collected from an adjunctive therapy study were comparable between asenapine-treated patients and placebo-treated patients … |
| Ziprasidone | warnings and precautions | … antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and antibiotics (e.g., gatifloxacin, moxifloxacin). |
Source: FDA drug label (SAPHRIS), NDA022117 (Abbvie), as published by Allergan, Inc., effective January 31, 2025 (SPL set 5429f134-839f-4ffc-9944-55f51238def8), via openFDA; the full label on DailyMed
What do FAERS reports show for asenapine?
The FDA Adverse Event Reporting System holds 8,667 reports that list asenapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 415 are coded as a death and 1,460 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does asenapine compare with medicines for the same use?
2 side-by-side pages set asenapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to asenapine
- medicines labeled for the same conditions
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Asenapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other