FDA Orange Book · active-ingredient family
Brivaracetam
Brivaracetam: 3 brands, 16 generics; first approved May 12, 2016; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
2
Next patent expiry
Feb 21, 2026
5 mo ago
Brand (NDA) products
Originator applications
- UCB INCNDA 2058372016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP - UCB INCNDA 2058382016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVIACTRLDUCB INCNDA 20583620165 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Generic (ANDA) products (16)
Abbreviated applications
- BRIVARACETAMSCIEGEN PHARMSANDA 21995220265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMHAINAN POLYANDA 2182492026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP - BRIVARACETAMMICRO LABSANDA 2148802026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP - BRIVARACETAMMSNANDA 2149242026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP - BRIVARACETAMALKEM LABS LTDANDA 2197722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVARACETAMLUPINANDA 2201642026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVARACETAMREGCON HOLDINGSANDA 2203852026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVARACETAMZHEJIANG POLY PHARMANDA 2184942026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVARACETAMAPOTEXANDA 21487520265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMCENTAUR PHARMS PVTANDA 22047020265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMMSNANDA 2149222026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - BRIVARACETAMMSNANDA 21492120255 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMAUROBINDO PHARMA LTDANDA 21484820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMLUPINANDA 21491820225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - BRIVARACETAMZYDUS PHARMSANDA 21450120225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - BRIVARACETAMSUNSHINEANDA 21474820225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 6911461 | 5 mo ago | SubstanceProductU-1815 | |
| 10729653 | in 3 yr 9 mo | Product |
Approval history
FDA approval span
First approval
10 yr 5 mo ago
Most recent approval
1 mo ago
Approvals span 2016–2026 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Brivaracetam: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
