Prescription medicine
Cenobamate Brand names: Xcopri
Cenobamate (Xcopri) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $39.87 per Xcopri 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- DEA Schedule V
Check it at the source: the cenobamate FDA label on DailyMed (effective August 25, 2025, SK Life Science, Inc.); the NDA 212839 record on Drugs@FDA; every cenobamate label on DailyMed.
Highlights of the record
FDA label of August 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXCOPRI is indicated for the treatment of partial-onset seizures in adult patients.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 100 mg
- 150 mg
- 200 mg
Kit; film-coated tablet; tablet.
On the market
- Earliest approval on file
- November 21, 2019 Xcopri, Sk Life; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 16, 2039 Xcopri tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $39.87 per tablet Xcopri 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,296 through July 30, 2026
What is cenobamate used for?
From the label: indications and usageXCOPRI is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.
Conditions named in the indications of cenobamate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Xcopri), SK Life Science, Inc., effective August 25, 2025 (SPL set 565c2126-57ae-4e29-b443-723bbe7e2072), via openFDA; the full label on DailyMed
What does the patient leaflet for cenobamate 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 XCOPRI?XCOPRI can cause serious side effects, including: Serious or life threatening allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue trouble swallowing or breathing a skin rash hives fever, swollen glands, or sore throat that does not go away or comes and goes painful sores in the mouth or around your eyes yellowing of your skin or eyes unusual bruising or bleeding severe fatigue or weakness severe muscle pain frequent infections that do not go away These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking XCOPRI. Problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Like other antiepileptic drugs, XCOPRI may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Suicidal thoughts or actions may be caused by things other than medicines. […]
From the patient leaflet: What should I avoid while taking XCOPRI?Do not drive, operate machinery, or do other dangerous activities until you know how XCOPRI affects you. XCOPRI may slow your thinking and motor skills and may affect your vision. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.
From the patient leaflet: How should I store XCOPRI?Store XCOPRI at room temperature between 68℉ to 77℉ (20℃ to 25℃). Safely throw away medicine that is out of date or no longer needed. Keep XCOPRI and all medicines out of the reach of children.
Source: FDA drug label (Xcopri), SK Life Science, Inc., effective August 25, 2025 (SPL set 565c2126-57ae-4e29-b443-723bbe7e2072), via openFDA; the full label on DailyMed
Is there a generic for cenobamate (Xcopri)?
No generic cenobamate is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Xcopri tablets: the compound patent runs to October 30, 2032, and the last listed entry to June 16, 2039. 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
- 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 cenobamate (Xcopri)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $39.87 per Xcopri 100 mg tablet, up 3% from $38.79 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.
- Xcopri 12.5-25 mg titration pk (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Xcopri 100 mg tablet | Brand | $39.87 per tablet | $1,196.15 | +3% |
| Xcopri 12.5-25 mg titration pk | Brand | $3.91 per unit | n/a | +3% |
| Xcopri 150 mg tablet | Brand | $39.86 per tablet | $1,195.89 | +3% |
| Xcopri 150-200 mg titration pk | Brand | $42.91 per unit | n/a | +4% |
| Xcopri 200 mg tablet | Brand | $39.88 per tablet | $1,196.32 | +3% |
| Xcopri 25 mg tablet | Brand | $39.88 per tablet | $1,196.46 | +3% |
| Xcopri 250 mg daily dose pack | Brand | $21.37 per unit | n/a | +3% |
| Xcopri 350 mg daily dose pack | Brand | $42.70 per unit | n/a | +3% |
| Xcopri 50 mg tablet | Brand | $39.86 per tablet | $1,195.70 | +3% |
| Xcopri 50-100 mg titration pak | Brand | $42.71 per unit | n/a | +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 cenobamate label say about other medicines?
The cenobamate label names 5 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 |
|---|---|---|
| Carbamazepine | drug interactions | Reduce dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) Lamotrigine, Carbamazepine: |
| Clobazam | drug interactions | DRUG INTERACTIONS Phenytoin: Gradually decrease phenytoin dosage by up to 50%. ( 7.1 ) Phenobarbital and Clobazam: |
| Lamotrigine | drug interactions | Reduce dosage as needed when used concomitantly with XCOPRI. ( 7.1 ) Lamotrigine, Carbamazepine: |
| Phenobarbital | drug interactions | DRUG INTERACTIONS Phenytoin: Gradually decrease phenytoin dosage by up to 50%. ( 7.1 ) Phenobarbital and Clobazam: |
| Phenytoin | drug interactions | DRUG INTERACTIONS Phenytoin: Gradually decrease phenytoin dosage by up to 50%. ( 7.1 ) Phenobarbital and Clobazam: |
Source: FDA drug label (Xcopri), SK Life Science, Inc., effective August 25, 2025 (SPL set 565c2126-57ae-4e29-b443-723bbe7e2072), via openFDA; the full label on DailyMed
What do FAERS reports show for cenobamate?
The FDA Adverse Event Reporting System holds 8,296 reports that list cenobamate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 197 are coded as a death and 1,666 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 (2,052, against a median of 83 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 cenobamate?
18 other medicines are given the same way (oral) and in the same FDA class as cenobamate or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 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 |
|---|---|---|---|---|
| Topiramate | Seizures and epilepsy | 47 labelers | $0.0567 per tablet 100 mg tablet | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Levetiracetam | Seizures and epilepsy | 63 labelers | $0.0736 per tablet 500 mg tablet | No current entry |
| Phenobarbital | Seizures and epilepsy | none listed | $0.213 per tablet 100 mg tablet | A presentation being discontinued |
| Clonazepam | Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lacosamide | Seizures and epilepsy | 43 labelers | $0.174 per tablet 100 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Brivaracetam | Seizures and epilepsy | 14 labelers | $0.259 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as cenobamate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cenobamate compare with medicines for the same use?
3 side-by-side pages set cenobamate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cenobamate
- 18 medicines for the same use
- Cenobamate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other