Orange Book product · Brand (NDA)
TROKENDI XR
TOPIRAMATE
At a glance
Aug 16, 2013
Approved
Brand (NDA)
Application
AB1
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2013
13 yr ago
Today
Patent 10314790 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 10314790 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8298580 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8298580 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8663683 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8663683 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8877248 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8877248 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8889191 expires
Listed method-of-use patent (U-106) expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8889191 expires
Listed method-of-use patent (U-1992) expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8992989 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8992989 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9549940 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9549940 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9555004 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9555004 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9622983 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 9622983 expires
Listed drug product patent expiration.
Nov 16, 2027
in 1 yr 5 mo
Patent 8298576 expires
Listed drug product patent expiration.
Apr 04, 2028
in 1 yr 10 mo
Patent 8298576 expires
Listed drug product patent expiration.
Apr 04, 2028
in 1 yr 10 mo
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
50MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
NDA 201635
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2021EPRONTIABrand (NDA)
NDA 214679 · AZURITY
- 2014QUDEXY XRBrand (NDA)
NDA 205122 · UPSHER SMITH LABS
- 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 (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10314790 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 10314790 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 8298580 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-106 |
| 8298580 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8663683 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-106 |
| 8663683 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8877248 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8877248 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-106 |
| 8889191 | Nov 16, 2027 | in 1 yr 5 mo | U-106 |
| 8889191 | Nov 16, 2027 | in 1 yr 5 mo | U-1992 |
| 8992989 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 8992989 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 9549940 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 9549940 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 9555004 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 9555004 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 9622983 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 9622983 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 8298576 | Apr 04, 2028 | in 1 yr 10 mo | ProductU-1992 |
| 8298576 | Apr 04, 2028 | in 1 yr 10 mo | ProductU-106 |
