Orange Book product · Brand (NDA)
VIMPAT
LACOSAMIDE
At a glance
Oct 28, 2008
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2008
17 yr 11 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
200MG/20ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022254
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
- 2010VIMPATBrand (NDA)
NDA 022255 · 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.
