FDA Orange Book · active-ingredient family
Topiramate
Topiramate is approved as 5 brand and 51 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EPRONTIA · NDA 214679
5
Brand (NDA)
51
Generics (ANDA)
20
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPRONTIARLD | AZURITY | NDA 214679 | AB | Nov 05, 2021 | |
| QUDEXY XRRLD×5 | UPSHER SMITH LABS | NDA 205122 | AB2 | Mar 11, 2014 | |
| TROKENDI XRRLD×4 | SUPERNUS PHARMS | NDA 201635 | AB1 | Aug 16, 2013 | |
| TOPAMAXRLD×3 | JANSSEN PHARMS | NDA 020844 | AB | Oct 26, 1998 | |
| TOPAMAXRLD×6 | JANSSEN PHARMS | NDA 020505 | AB | Dec 24, 1996 |
Generic (ANDA) products (51)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOPIRAMATE×5 | RICONPHARMA LLC | ANDA 220041 | AB2 | May 26, 2026 | |
| TOPIRAMATE×4 | ASCENT PHARMS INC | ANDA 217443 | AB1 | Jan 12, 2026 | |
| TOPIRAMATE×5 | AJANTA PHARMA LTD | ANDA 219564 | AB2 | Sep 02, 2025 | |
| TOPIRAMATE×3 | RUBICON RESEARCH | ANDA 216683 | AB | May 27, 2025 | |
| TOPIRAMATE×5 | AMTA | ANDA 218695 | AB2 | Dec 03, 2024 | |
| TOPIRAMATE×5 | XIAMEN LP PHARM CO | ANDA 215638 | AB2 | Nov 05, 2024 | |
| TOPIRAMATE | ALKEM LABS LTD | ANDA 217795 | AB | Oct 31, 2024 | |
| TOPIRAMATE×2 | SENORES PHARMS | ANDA 218642 | AB | Oct 10, 2024 | |
| TOPIRAMATE×2 | GLENMARK PHARMS LTD | ANDA 217869 | AB | Jul 16, 2024 | |
| TOPIRAMATE×4 | LUPIN | ANDA 215561 | AB1 | Jul 11, 2024 | |
| TOPIRAMATE×2 | ALKEM LABS LTD | ANDA 218482 | AB | Jun 13, 2024 | |
| TOPIRAMATE×2 | TWI PHARMS | ANDA 217694 | AB | Dec 05, 2023 | |
| TOPIRAMATE×4 | DR REDDYS | ANDA 217231 | AB1 | Nov 17, 2023 | |
| TOPIRAMATE×2 | AUROBINDO PHARMA LTD | ANDA 215449 | AB | Sep 27, 2023 | |
| TOPIRAMATE×4 | AJANTA PHARMA LTD | ANDA 215663 | AB1 | Aug 15, 2023 | |
| TOPIRAMATE×4 | ALKEM LABS LTD | ANDA 217248 | AB1 | Jun 20, 2023 | |
| TOPIRAMATE×4 | PH HEALTH | ANDA 205976 | AB1 | May 04, 2023 | |
| TOPIRAMATE×4 | ACTAVIS LABS FL | ANDA 206210 | AB1 | Mar 10, 2023 | |
| TOPIRAMATE | ZYDUS PHARMS | ANDA 216167 | — | Feb 09, 2023 | |
| TOPIRAMATE×5 | ZYDUS | ANDA 208949 | AB2 | Nov 29, 2022 | |
| TOPIRAMATE×4 | ASCENT PHARMS INC | ANDA 215414 | AB | Aug 26, 2021 | |
| TOPIRAMATE×5 | GLENMARK PHARMS LTD | ANDA 210278 | AB2 | Feb 01, 2021 | |
| TOPIRAMATE×4 | ZYDUS | ANDA 207382 | AB1 | Nov 24, 2017 | |
| TOPIRAMATE×4 | HIKMA PHARMS | ANDA 091185 | — | Nov 25, 2013 | |
| TOPIRAMATE×4 | CHARTWELL | ANDA 078410 | — | Sep 11, 2013 | |
| TOPIRAMATE×4 | ACTAVIS TOTOWA | ANDA 078637 | — | Feb 27, 2013 | |
| TOPIRAMATE×4 | SENORES PHARMS | ANDA 090353 | — | Sep 01, 2010 | |
| TOPIRAMATE×4 | AIPING PHARM INC | ANDA 078499 | — | Jan 07, 2010 | |
| TOPIRAMATE×2 | CHARTWELL RX | ANDA 079206 | — | Oct 14, 2009 | |
| TOPIRAMATE×3 | STRIDES PHARMA | ANDA 078418 | AB | Oct 14, 2009 | |
| TOPIRAMATE×3 | ZYDUS PHARMS USA INC | ANDA 078877 | AB | Oct 14, 2009 | |
| TOPIRAMATE×2 | TEVA | ANDA 076575 | — | Apr 17, 2009 | |
| TOPIRAMATE×2 | BARR | ANDA 076448 | — | Apr 15, 2009 | |
| TOPIRAMATE×2 | WATSON LABS | ANDA 077868 | — | Apr 15, 2009 | |
| TOPIRAMATE×4 | PLIVA HRVATSKA DOO | ANDA 077905 | — | Mar 30, 2009 | |
| TOPIRAMATE×4 | ACCORD HLTHCARE | ANDA 076311 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | AUROBINDO PHARMA | ANDA 078462 | AB | Mar 27, 2009 | |
| TOPIRAMATE×3 | BARR | ANDA 076315 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | CIPLA LTD | ANDA 076343 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | GLENMARK PHARMS LTD | ANDA 077627 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | INVAGEN PHARMS | ANDA 079162 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | NATCO | ANDA 076314 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | PHARMACO | ANDA 077733 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | ROXANE | ANDA 076306 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | SUN PHARM | ANDA 090278 | AB | Mar 27, 2009 | |
| TOPIRAMATE×3 | SUN PHARM INDS LTD | ANDA 076327 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | TEVA | ANDA 076317 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | TORRENT PHARMS | ANDA 079153 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | UNICHEM LABS LTD | ANDA 090162 | AB | Mar 27, 2009 | |
| TOPIRAMATE×4 | WATSON LABS | ANDA 077643 | — | Mar 27, 2009 | |
| TOPIRAMATE×4 | ZYDUS PHARMS USA INC | ANDA 078235 | AB | Mar 27, 2009 |
Marketing exclusivity (2)
- CGTFDA marketing exclusivity
Feb 01, 2026
5 mo ago
- PCPatent-challenge (180-day generic) exclusivity
Jan 05, 2026
6 mo ago
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8663683 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8992989 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 8889191 | Nov 16, 2027 | in 1 yr 5 mo | U-106 |
| 9549940 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8298580 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8877248 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 9555004 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 10314790 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1675 |
| 9622983 | Nov 16, 2027 | in 1 yr 5 mo | ProductU-1992 |
| 8298576 | Apr 04, 2028 | in 1 yr 10 mo | ProductU-106 |
| 10363224 | Mar 19, 2033 | in 6 yr 10 mo | U-766 |
| 9101545 | Mar 19, 2033 | in 6 yr 10 mo | Product |
| 9555005 | Mar 19, 2033 | in 6 yr 10 mo | Product |
| 8652527 | Mar 19, 2033 | in 6 yr 10 mo | Product |
| 8889190 | Mar 19, 2033 | in 6 yr 10 mo | Product |
| 11433046 | Aug 21, 2040 | in 14 yr 5 mo | U-3413 |
| 12290503 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3413 |
| 11911362 | Aug 21, 2040 | in 14 yr 5 mo | ProductU-3413 |
| 11826343 | Aug 21, 2040 | in 14 yr 5 mo | Product |
| 11633374 | Aug 21, 2040 | in 14 yr 5 mo | Product |
Topiramate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
