FDA Orange Book
Generic for Briviact
Briviact contains brivaracetam. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Briviact is brivaracetam. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Briviact products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 50MG/5ML (10MG/ML) | Marketed (Rx) | AP | 4 | AP |
| solution, oral | 10MG/ML | Marketed (Rx) | AA | 6 | AA |
| tablet, oral | 100MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 10MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 75MG | Marketed (Rx) | AB | 6 | AB |
NDA 205837, 205838, 205836, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brivaracetam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUNSHINE LAKE PHARMA CO LTD | 214748 | AB (A-rated, therapeutically equivalent) | June 9, 2022 | 100MG, 10MG, 25MG, 50MG, 75MG |
| ZYDUS PHARMACEUTICALS USA INC | 214501 | AB (A-rated, therapeutically equivalent) | October 3, 2022 | 100MG, 10MG, 25MG, 50MG, 75MG |
| AUROBINDO PHARMA LTD | 214848 | AB (A-rated, therapeutically equivalent) | January 6, 2023 | 100MG, 10MG, 25MG, 50MG, 75MG |
| MSN LABORATORIES PRIVATE LTD | 214921 | AB (A-rated, therapeutically equivalent) | November 13, 2025 | 100MG, 10MG, 25MG, 50MG, 75MG |
| MSN LABORATORIES PRIVATE LTD | 214922 | AA (A-rated, therapeutically equivalent) | February 19, 2026 | 10MG/ML |
| HAINAN POLY PHARM CO LTD | 218249 | AP (A-rated, therapeutically equivalent) | February 23, 2026 | 50MG/5ML (10MG/ML) |
| MICRO LABS LTD | 214880 | AP (A-rated, therapeutically equivalent) | February 23, 2026 | 50MG/5ML (10MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 214924 | AP (A-rated, therapeutically equivalent) | February 23, 2026 | 50MG/5ML (10MG/ML) |
| ALKEM LABORATORIES LTD | 219772 | AA (A-rated, therapeutically equivalent) | February 23, 2026 | 10MG/ML |
| LUPIN INC | 220164 | AA (A-rated, therapeutically equivalent) | February 23, 2026 | 10MG/ML |
| REGCON HOLDINGS LLC | 220385 | AA (A-rated, therapeutically equivalent) | February 23, 2026 | 10MG/ML |
| ZHEJIANG POLY PHARM CO LTD | 218494 | AA (A-rated, therapeutically equivalent) | February 23, 2026 | 10MG/ML |
| APOTEX INC | 214875 | AB (A-rated, therapeutically equivalent) | February 23, 2026 | 100MG, 10MG, 25MG, 50MG, 75MG |
| SCIEGEN PHARMACEUTICALS INC | 219952 | AB (A-rated, therapeutically equivalent) | July 1, 2026 | 100MG, 10MG, 25MG, 50MG, 75MG |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 219766 | AP (A-rated, therapeutically equivalent) | July 13, 2026 | 50MG/5ML (10MG/ML) |
| AUROBINDO PHARMA LTD | 220288 | AA (A-rated, therapeutically equivalent) | August 10, 2026 | 10MG/ML |
| ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | 220136 | AB (A-rated, therapeutically equivalent) | September 8, 2026 | 100MG, 25MG, 50MG |
Briviact patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6911461 | February 21, 2026 | Drug substance, Drug product | U-1815 | 205837 |
| 6911461 | February 21, 2026 | Drug substance, Drug product | U-2130 | 205837 |
| 6911461 | February 21, 2026 | Drug substance, Drug product | U-2295 | 205838 |
| 10729653 | April 9, 2030 | Drug product | None | 205836 |
Briviact NDC codes
Questions
Is there a generic for Briviact?
Yes. The generic name for Briviact is brivaracetam. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Briviact?
The active ingredient in Briviact is brivaracetam, per the FDA Orange Book.
When does the Briviact patent expire?
The last patent listed for Briviact in the Orange Book expires April 9, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Briviact and Brivaracetam
- What is Briviact used for?FDA label uses
- Is Briviact a controlled substance?Schedule V
- What is Brivaracetam used for?FDA label uses
- Is Brivaracetam a controlled substance?Schedule V
- Briviact Medicare Part D coverageBy plan and state
- NDC 50474-370Briviact NDC record
- NDC 50474-470Briviact NDC record
- NDC 50474-570Briviact NDC record
- Schedule V drugs listDEA schedule