Orange Book product · Brand (NDA)
EPRONTIA
TOPIRAMATE
At a glance
Nov 05, 2021
Approved
Brand (NDA)
Application
AB
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2021
4 yr 8 mo ago
Today
Patent 11433046 expires
Listed method-of-use patent (U-3413) expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11433046 expires
Listed method-of-use patent (U-3414) expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11433046 expires
Listed method-of-use patent (U-3415) expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11633374 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11826343 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11911362 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11911362 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 11911362 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 12290503 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 12290503 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Patent 12290503 expires
Listed drug product patent expiration.
Aug 21, 2040
in 14 yr 5 mo
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
25MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AB
Application
NDA 214679
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.
- 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 217795 · ALKEM LABS LTD
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218642 · SENORES PHARMS
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11433046 | Aug 21, 2040 | in 14 yr 5 mo | U-3413 |
| 11433046 | Aug 21, 2040 | in 14 yr 5 mo | U-3414 |
| 11433046 | Aug 21, 2040 | in 14 yr 5 mo | U-3415 |
| 11633374 | Aug 21, 2040 | in 14 yr 5 mo | Product |
| 11826343 | Aug 21, 2040 | in 14 yr 5 mo | Product |
| 11911362 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3413 |
| 11911362 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3414 |
| 11911362 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3415 |
| 12290503 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3413 |
| 12290503 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3415 |
| 12290503 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3414 |
