Prescription medicine
Gepirone Brand names: Exxua
Gepirone (Exxua) is a prescription medicine with an FDA approval on record since 2023. No generic is listed; pharmacies paid $57.47 per tablet (Exxua ER 18.2 mg tablet (titratn)) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the gepirone FDA label on DailyMed (effective July 14, 2026, Aytu Therapeutics, LLC); the NDA 21164 record on Drugs@FDA; every gepirone label on DailyMed.
Highlights of the record
FDA label of July 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1 ) ]. EXXUA is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). EXXUA is not approved for use in pediatric patients ( 8.4 ).
Used for
From the label: indications and usageEXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.
Forms and strengths
- 18.2 mg
- 36.3 mg
- 54.5 mg
- 72.6 mg
Extended-release tablet.
On the market
- Earliest approval on file
- September 22, 2023 Exxua, Fabre Kramer; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- September 2, 2030 Exxua tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $57.47 per tablet Exxua ER 18.2 mg tablet (titratn)
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2 through July 30, 2026
What is gepirone used for?
From the label: indications and usageEXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Conditions named in the indications of gepirone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (EXXUA), NDA021164 (Fabre Kramer), as published by Aytu Therapeutics, LLC, effective July 14, 2026 (SPL set 0c78edd8-6acb-433c-9d34-2527da8d64e1), via openFDA; the full label on DailyMed
What does the patient leaflet for gepirone 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 EXXUA?EXXUA may cause serious side effects, including: Increased risk of suicidal thoughts and actions. EXXUA and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. EXXUA is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when an 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. Call a healthcare provider or get emergency medical help right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood
From the patient leaflet: How should I store EXXUA?Store EXXUA at room temperature between 68°F to 77°F (20°C to 25°C) Protect from high humidity and moisture. Keep EXXUA and all medicines out of the reach of children.
Source: FDA drug label (EXXUA), NDA021164 (Fabre Kramer), as published by Aytu Therapeutics, LLC, effective July 14, 2026 (SPL set 0c78edd8-6acb-433c-9d34-2527da8d64e1), via openFDA; the full label on DailyMed
Is there a generic for gepirone (Exxua)?
No generic gepirone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Exxua tablets, the last expiring on September 2, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for gepirone (Exxua)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $57.47 per tablet (Exxua ER 18.2 mg tablet (titratn)). 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.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Exxua ER 18.2 mg tablet (titratn) | Brand | $57.47 per tablet | $1,724.13 | n/a |
| Exxua ER 54.5 mg tablet | Brand | $56.57 per tablet | $1,697.20 | n/a |
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 gepirone label say about other medicines?
The gepirone label names 2 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 |
|---|---|---|
| Linezolid | contraindications | Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated. |
| Methylene blue | contraindications | Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated. |
Source: FDA drug label (EXXUA), NDA021164 (Fabre Kramer), as published by Aytu Therapeutics, LLC, effective July 14, 2026 (SPL set 0c78edd8-6acb-433c-9d34-2527da8d64e1), via openFDA; the full label on DailyMed
What do FAERS reports show for gepirone?
The FDA Adverse Event Reporting System holds 2 reports that list gepirone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 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.
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 gepirone?
30 other medicines are given the same way (oral) and in the same FDA class as gepirone or labeled mainly for the same use (depression), the same class first. Depression lists all 37 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 |
|---|---|---|---|---|
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to gepirone
- 30 medicines for the same use
- Gepirone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other