Prescription medicine
Brivaracetam Brand names: Briviact
Brivaracetam (Briviact) is a prescription medicine with an FDA approval on record since 2016. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.259 per brivaracetam 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule V
Check it at the source: the brivaracetam FDA label on DailyMed (effective August 20, 2026, UCB, Inc.); the NDA 205837 record on Drugs@FDA; every brivaracetam label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 10 mg/ml
- 50 mg/5ml
Film-coated tablet; solution; tablet; injection; injection (suspension).
On the market
- Earliest approval on file
- February 18, 2016 Briviact, Ucb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first June 9, 2022; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 9, 2030 Briviact tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.259 per tablet Brivaracetam 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 8,940 through July 30, 2026
What is brivaracetam used for?
From the label: indications and usageBRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Conditions named in the indications of brivaracetam's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Briviact), NDA205836 (Ucb Inc), as published by UCB, Inc., effective August 20, 2026 (SPL set 3cf2f439-0e97-443e-8e33-25ecef616f6c), via openFDA; the full label on DailyMed
What does the patient leaflet for brivaracetam 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 BRIVIACT?BRIVIACT is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep BRIVIACT in a safe place to prevent misuse and abuse. Selling or giving away BRIVIACT may harm others and is against the law. Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. 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 new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, feeling angry, or being 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 Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop BRIVIACT without first talking to a healthcare provider. Stopping BRIVIACT suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
From the patient leaflet: What should I avoid while taking BRIVIACT?Do not drive or operate machinery until you know how BRIVIACT affects you. BRIVIACT may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.
From the patient leaflet: How should I store BRIVIACT?Store BRIVIACT at room temperature between 59°F to 86°F (15°C to 30°C). Do not freeze BRIVIACT oral solution. Safely throw away any opened bottle of BRIVIACT oral solution after 5 months of first opening the bottle, even if there is medicine left in the bottle. Keep BRIVIACT and all medicines out of the reach of children.
Source: FDA drug label (Briviact), NDA205836 (Ucb Inc), as published by UCB, Inc., effective August 20, 2026 (SPL set 3cf2f439-0e97-443e-8e33-25ecef616f6c), via openFDA; the full label on DailyMed
Is there a generic for brivaracetam (Briviact)?
The FDA approved the first generic brivaracetam on June 9, 2022. 19 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists brivaracetam from 16 labelers under a generic (ANDA) application and from 1 brand labeler. 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 Briviact tablets: the compound patent runs to February 21, 2026, and the last listed entry to April 9, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2022 first generic approved
- 2030 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 brivaracetam (Briviact)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.259 per Brivaracetam 100 mg tablet. 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.
- Brivaracetam 50 mg tablet (generic)
- Briviact 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Brivaracetam 10 mg/mL oral solution | Generic | $0.267 per mL | n/a | n/a |
| Brivaracetam 100 mg tablet | Generic | $0.259 per tablet | $7.76 | n/a |
| Brivaracetam 25 mg tablet | Generic | $0.222 per tablet | $6.67 | n/a |
| Brivaracetam 50 mg tablet | Generic | $0.189 per tablet | $5.66 | n/a |
| Brivaracetam 75 mg tablet | Generic | $0.266 per tablet | $7.98 | n/a |
| Briviact 10 mg tablet | Brand | $23.99 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $719.59 | +3% |
| Briviact 10 mg/mL oral solution | Brand | $4.81 per mL | n/a | +2% |
| Briviact 100 mg tablet | Brand | $24.07 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $722.10 | +2% |
| Briviact 25 mg tablet | Brand | $24.07 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $721.98 | +3% |
| Briviact 50 mg tablet | Brand | $24.07 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $722.23 | +3% |
| Briviact 75 mg tablet | Brand | $24.06 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $721.74 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has brivaracetam been recalled?
The FDA's Enforcement Report lists 1 recall naming brivaracetam since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the brivaracetam label say about other medicines?
The brivaracetam label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name brivaracetam. 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 | Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant BRIVIACT. |
| Levetiracetam | drug interactions | BRIVIACT had no added therapeutic benefit when co-administered with levetiracetam. |
| Phenytoin | drug interactions | Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant BRIVIACT. |
| Rifampin | drug interactions | DRUG INTERACTIONS Rifampin: Because of decreased concentrations, increasing BRIVIACT dosage in patients on concomitant rifampin is recommended. |
Source: FDA drug label (Briviact), NDA205836 (Ucb Inc), as published by UCB, Inc., effective August 20, 2026 (SPL set 3cf2f439-0e97-443e-8e33-25ecef616f6c), via openFDA; the full label on DailyMed
What do FAERS reports show for brivaracetam?
The FDA Adverse Event Reporting System holds 8,940 reports that list brivaracetam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 446 are coded as a death and 2,446 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
What else is labeled for the same conditions as brivaracetam?
18 other medicines are given the same way (oral) and in the same FDA class as brivaracetam 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 |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as brivaracetam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does brivaracetam compare with medicines for the same use?
3 side-by-side pages set brivaracetam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to brivaracetam
- 18 medicines for the same use
- Brivaracetam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other