Prescription medicine
Trospium and xanomeline Brand names: Cobenfy
Trospium and xanomeline (Cobenfy) is a prescription medicine with an FDA approval on record since 2024. No generic is listed; pharmacies paid $30.13 per Cobenfy 100 mg-20 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the trospium and xanomeline FDA label on DailyMed (effective January 16, 2026, E.R. Squibb & Sons, L.L.C.); the NDA 216158 record on Drugs@FDA; every trospium and xanomeline label on DailyMed.
Highlights of the record
FDA label of January 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCOBENFY is indicated for the treatment of schizophrenia in adults.
Forms and strengths
- 50 mg / 20 mg
- 100 mg / 20 mg
- 125 mg / 30 mg
Capsule (coated pellets); kit.
On the market
- Earliest approval on file
- September 26, 2024 Cobenfy, Bristol-Myers; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- October 29, 2039 Cobenfy capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $30.13 per capsule Cobenfy 100 mg-20 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,089 through July 30, 2026
What is trospium and xanomeline used for?
From the label: indications and usageCOBENFY is indicated for the treatment of schizophrenia in adults. COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults.
Conditions named in the indications of trospium and xanomeline's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Agonist and Cholinergic Muscarinic Antagonist.
Source: FDA drug label (Cobenfy), NDA216158 (Bristol-Myers), as published by E.R. Squibb & Sons, L.L.C., effective January 16, 2026 (SPL set 8f0e73bf-6025-44f6-ab64-0983322de0df), via openFDA; the full label on DailyMed
What does the patient leaflet for trospium and xanomeline say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking COBENFY?Do not drive, operate heavy machinery, or do other dangerous activities until you know how COBENFY affects you. COBENFY may cause dizziness, confusion, seeing or hearing things that are not real (hallucinations), and sleepiness.
From the patient leaflet: How should I store COBENFY?Store COBENFY at room temperature between 68°F to 77°F (20°C to 25°C). Keep COBENFY and all medicines out of the reach of children.
Source: FDA drug label (Cobenfy), NDA216158 (Bristol-Myers), as published by E.R. Squibb & Sons, L.L.C., effective January 16, 2026 (SPL set 8f0e73bf-6025-44f6-ab64-0983322de0df), via openFDA; the full label on DailyMed
Is there a generic for trospium and xanomeline (Cobenfy)?
No generic trospium and xanomeline is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Cobenfy capsules, the last expiring on October 29, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trospium and xanomeline (Cobenfy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $30.13 per Cobenfy 100 mg-20 mg capsule, up 2% from $29.65 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.
- Cobenfy 100 mg-20 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cobenfy 100 mg-20 mg capsule | Brand | $30.13 per capsule | $903.96 | +2% |
| Cobenfy 125 mg-30 mg capsule | Brand | $30.23 per capsule | $906.91 | +2% |
| Cobenfy 50 mg-20 mg capsule | Brand | $30.23 per capsule | $906.94 | +2% |
| Cobenfy starter pack | Brand | $30.07 per unit | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for trospium and xanomeline?
The FDA Adverse Event Reporting System holds 2,089 reports that list trospium and xanomeline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 189 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 (1,254, against a median of 0 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 trospium and xanomeline?
16 other medicines are given the same way (oral) and in the same FDA class as trospium and xanomeline 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 | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Haloperidol | Schizophrenia | 28 labelers | $0.181 per tablet 5 mg tablet | A presentation being discontinued |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Chlorpromazine | Schizophrenia | 22 labelers | $0.552 per tablet 100 mg tablet | No current entry |
| Perphenazine | Schizophrenia | 16 labelers | $0.161 per tablet 4 mg tablet | 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 trospium and xanomeline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to trospium and xanomeline
- 16 medicines for the same use
- Other cholinergic muscarinic agonists
- the pharmacologic class, with prices and generics
- Trospium and xanomeline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other