FDA Orange Book
Generic for Vimpat
Vimpat contains lacosamide. 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 Vimpat is lacosamide. 29 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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Vimpat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 200MG/20ML (10MG/ML) | Marketed (Rx) | AP | 14 | AP |
| solution, oral | 10MG/ML | Marketed (Rx) | AA | 10 | AA |
| tablet, oral | 100MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 150MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 12 | AB |
NDA 022254, 022255, 022253, 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 lacosamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 204974 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 205006 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| HETERO LABS LTD UNIT V | 204787 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| MSN LABORATORIES PRIVATE LTD | 204921 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| REGCON HOLDINGS LLC | 208308 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| SCIEGEN PHARMACEUTICALS INC | 205237 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 205031 | AB (A-rated, therapeutically equivalent) | March 17, 2022 | 100MG, 150MG, 200MG, 50MG |
| ALKEM LABORATORIES LTD | 214695 | AB (A-rated, therapeutically equivalent) | March 31, 2022 | 100MG, 150MG, 200MG, 50MG |
| REGCON HOLDINGS LLC | 214301 | AP (A-rated, therapeutically equivalent) | April 7, 2022 | 200MG/20ML (10MG/ML) |
| FRESENIUS KABI USA LLC | 214677 | AP (A-rated, therapeutically equivalent) | May 3, 2022 | 200MG/20ML (10MG/ML) |
| ALKEM LABORATORIES LTD | 214672 | AA (A-rated, therapeutically equivalent) | May 19, 2022 | 10MG/ML |
| HETERO LABS LTD UNIT III | 209301 | AA (A-rated, therapeutically equivalent) | May 31, 2022 | 10MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 209465 | AP (A-rated, therapeutically equivalent) | June 29, 2022 | 200MG/20ML (10MG/ML) |
| NOVITIUM PHARMA LLC | 216151 | AA (A-rated, therapeutically equivalent) | August 26, 2022 | 10MG/ML |
| ASPIRO PHARMA LTD | 216335 | AP (A-rated, therapeutically equivalent) | September 14, 2022 | 200MG/20ML (10MG/ML) |
| GLAND PHARMA LTD | 215628 | AP (A-rated, therapeutically equivalent) | September 19, 2022 | 200MG/20ML (10MG/ML) |
| AUROBINDO PHARMA LTD | 204994 | AB (A-rated, therapeutically equivalent) | January 5, 2023 | 100MG, 150MG, 200MG, 50MG |
| PHARMAZONE | 216461 | AA (A-rated, therapeutically equivalent) | February 6, 2023 | 10MG/ML |
| MSN LABORATORIES PRIVATE LTD | 215979 | AP (A-rated, therapeutically equivalent) | February 9, 2023 | 200MG/20ML (10MG/ML) |
| APOTEX INC | 216670 | AP (A-rated, therapeutically equivalent) | November 13, 2023 | 200MG/20ML (10MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 215379 | AA (A-rated, therapeutically equivalent) | December 22, 2023 | 10MG/ML |
| AUROBINDO PHARMA LTD | 209224 | AA (A-rated, therapeutically equivalent) | January 24, 2024 | 10MG/ML |
| HAINAN POLY PHARM CO LTD | 217311 | AP (A-rated, therapeutically equivalent) | February 13, 2024 | 200MG/20ML (10MG/ML) |
| DR REDDYS LABORATORIES LTD | 217718 | AP (A-rated, therapeutically equivalent) | March 25, 2024 | 200MG/20ML (10MG/ML) |
| PHARMAZONE | 218014 | AB (A-rated, therapeutically equivalent) | April 2, 2024 | 100MG, 150MG, 200MG, 50MG |
| HIKMA PHARMACEUTICALS USA INC | 216806 | AP (A-rated, therapeutically equivalent) | April 5, 2024 | 200MG/20ML (10MG/ML) |
| CHARTWELL RX SCIENCES LLC | 215154 | AA (A-rated, therapeutically equivalent) | May 15, 2024 | 10MG/ML |
| MACLEODS PHARMACEUTICALS LTD | 208466 | AB (A-rated, therapeutically equivalent) | May 24, 2024 | 100MG, 150MG, 200MG, 50MG |
| UNICHEM LABORATORIES LTD | 213109 | AB (A-rated, therapeutically equivalent) | September 4, 2024 | 100MG, 150MG, 200MG, 50MG |
| SOMERSET THERAPEUTICS LLC | 214960 | AP (A-rated, therapeutically equivalent) | October 9, 2024 | 200MG/20ML (10MG/ML) |
| ACELLA PHARMACEUTICALS LLC | 218464 | AP (A-rated, therapeutically equivalent) | November 14, 2024 | 200MG/20ML (10MG/ML) |
| OP NANOPHARMA CO LTD YUNLIN PLANT | 218706 | AP (A-rated, therapeutically equivalent) | May 23, 2025 | 200MG/20ML (10MG/ML) |
| AJENAT PHARMACEUTICALS LLC | 219699 | AA (A-rated, therapeutically equivalent) | June 26, 2025 | 10MG/ML |
| GLENMARK PHARMACEUTICALS INC USA | 220268 | AP (A-rated, therapeutically equivalent) | January 21, 2026 | 200MG/20ML (10MG/ML) |
| REGCON HOLDINGS LLC | 220386 | AA (A-rated, therapeutically equivalent) | January 29, 2026 | 10MG/ML |
| PRODUCT DEVELOPMENT PARTNERS LLC | 217596 | AA (A-rated, therapeutically equivalent) | June 15, 2026 | 10MG/ML |
Vimpat exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-188 | New dosing schedule | April 28, 2026 | 022254 |
Vimpat NDC codes
Questions
Is there a generic for Vimpat?
Yes. The generic name for Vimpat is lacosamide. 29 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 Vimpat?
The active ingredient in Vimpat is lacosamide, per the FDA Orange Book.
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 Vimpat and Lacosamide
- What is Vimpat used for?FDA label uses
- Is Vimpat a controlled substance?Schedule V
- What is Lacosamide used for?FDA label uses
- Is Lacosamide a controlled substance?Schedule V
- Generic for Motpoly XRFDA Orange Book
- NDC 0131-1810Vimpat NDC record
- NDC 0131-2477Vimpat NDC record
- NDC 0131-2478Vimpat NDC record
- Schedule V drugs listDEA schedule