Orange Book product · Brand (NDA)
VIMPAT
LACOSAMIDE
At a glance
Apr 20, 2010
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2010
16 yr 5 mo ago
Exclusivity ends · D-188
New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
LACOSAMIDE
Strength
10MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 022255
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023MOTPOLY XRBrand (NDA)
NDA 216185 · AUCTA
- 2008VIMPATBrand (NDA)
NDA 022254 · UCB INC
- 2008VIMPATBrand (NDA)
NDA 022253 · UCB INC
- 2026LACOSAMIDEGeneric (ANDA)
ANDA 220366 · STERANCO HLTHCARE
- 2026LACOSAMIDEGeneric (ANDA)
ANDA 220386 · REGCON HOLDINGS
- 2026LACOSAMIDEGeneric (ANDA)
ANDA 220268 · GLENMARK PHARMS
- 2025LACOSAMIDEGeneric (ANDA)
ANDA 219699 · AJENAT PHARMS
- 2025LACOSAMIDEGeneric (ANDA)
ANDA 218706 · WESTMINSTER PHARMS
- 2024LACOSAMIDEGeneric (ANDA)
ANDA 218464 · ACELLA
- 2024LACOSAMIDEGeneric (ANDA)
ANDA 214960 · SOMERSET THERAPS LLC
- 2024LACOSAMIDEGeneric (ANDA)
ANDA 213109 · UNICHEM
- 2024LACOSAMIDEGeneric (ANDA)
ANDA 208466 · MACLEODS PHARMS LTD
Marketing exclusivity (1)
- D-188New indication / change exclusivity (3 years)
Apr 28, 2026
2 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
