Orange Book product · Generic (ANDA)
TOPIRAMATE
TOPIRAMATE
At a glance
Oct 31, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2024
1 yr 8 mo ago
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Jan 05, 2026
6 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
25MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AB
Application
ANDA 217795
Product number
001
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
- 2025TOPIRAMATEGeneric (ANDA)
ANDA 216683 · RUBICON RESEARCH
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218695 · AMTA
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 215638 · XIAMEN LP PHARM CO
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218642 · SENORES PHARMS
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Jan 05, 2026
6 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.
