Prescription medicine
Vibegron Brand names: Gemtesa
Vibegron (Gemtesa) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $16.46 per Gemtesa 75 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the vibegron FDA label on DailyMed (effective April 1, 2025, Sumitomo Pharma America, Inc.); the NDA 213006 record on Drugs@FDA; every vibegron label on DailyMed.
Highlights of the record
FDA label of April 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Forms and strengths
- 75 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 23, 2020 Gemtesa, Sumitomo Pharma Am; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 6, 2042 Gemtesa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $16.46 per tablet Gemtesa 75 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,971 through July 30, 2026
What is vibegron used for?
From the label: indications and usageGEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). […]
Conditions named in the indications of vibegron's FDA labels, with every medicine labeled for each:
From other vibegron labelsOveractive bladder: Bladder in Adults GEMTESA ® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
FDA pharmacologic class: beta3-Adrenergic Agonist.
Source: FDA drug label (GEMTESA), Sumitomo Pharma America, Inc., effective April 1, 2025 (SPL set 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8), via openFDA; the full label on DailyMed
Is there a generic for vibegron (Gemtesa)?
No generic vibegron is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Gemtesa tablets: the compound patent runs to December 23, 2034, and the last listed entry to July 6, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for vibegron (Gemtesa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $16.46 per Gemtesa 75 mg tablet, up 3% from $15.99 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.
- Gemtesa 75 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gemtesa 75 mg tablet | Brand | $16.46 per tablet | $493.79 | +3% |
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 vibegron label say about other medicines?
The vibegron label names 1 other medicine 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 |
|---|---|---|
| Digoxin | drug interactions | DRUG INTERACTIONS Concomitant use of GEMTESA increases digoxin maximal concentrations (C max ) and systemic exposure as assessed by area under the concentration-time curve (AUC) [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (GEMTESA), Sumitomo Pharma America, Inc., effective April 1, 2025 (SPL set 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8), via openFDA; the full label on DailyMed
What do FAERS reports show for vibegron?
The FDA Adverse Event Reporting System holds 7,971 reports that list vibegron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 402 are coded as a death and 882 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 2025 (2,276, against a median of 19 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 vibegron?
7 other medicines are given the same way (oral) and in the same FDA class as vibegron or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Oxybutynin | Overactive bladder | 41 labelers | $0.048 per tablet 5 mg tablet | No current entry |
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vibegron
- 7 medicines for the same use
- Other beta3-adrenergic agonists
- the pharmacologic class, with prices and generics
- Vibegron side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other