Orange Book product · Generic (ANDA)
TOPIRAMATE
TOPIRAMATE
At a glance
May 27, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2025
1 yr 1 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Feb 01, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 216683
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOPIRAMATE
- 2021EPRONTIABrand (NDA)
NDA 214679 · AZURITY
- 2014QUDEXY XRBrand (NDA)
NDA 205122 · UPSHER SMITH LABS
- 2013TROKENDI XRBrand (NDA)
NDA 201635 · SUPERNUS PHARMS
- 1998TOPAMAXBrand (NDA)
NDA 020844 · JANSSEN PHARMS
- 1996TOPAMAXBrand (NDA)
NDA 020505 · JANSSEN PHARMS
- 2026TOPIRAMATEGeneric (ANDA)
ANDA 220041 · RICONPHARMA LLC
- 2026TOPIRAMATEGeneric (ANDA)
ANDA 217443 · ASCENT PHARMS INC
- 2025TOPIRAMATEGeneric (ANDA)
ANDA 219564 · AJANTA PHARMA LTD
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218695 · AMTA
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 215638 · XIAMEN LP PHARM CO
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 217795 · ALKEM LABS LTD
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218642 · SENORES PHARMS
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Feb 01, 2026
5 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.
