Drug
Who makes topiramate?
48 companies list topiramate as a human prescription drug, including under the names Eprontia, QUDEXY XR, Topamax, Trokendi XR. Forms: capsule; capsule, coated pellets; capsule, extended release; solution; tablet; tablet, coated; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing topiramate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA076343, ANDA077627, ANDA078235 | 18 | 1 |
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA076343, ANDA078235, ANDA090162 | 17 | 1 |
| Zydus Lifesciences LimitedIndia | capsule, coated pellets; capsule, extended release; tablet, film coated | ANDAANDA078235, ANDA078877, ANDA207382 | 16 | 12 |
| RemedyRepack, IncUnited States | capsule, coated pellets; tablet; tablet, film coated | ANDAANDA076343, ANDA077627, ANDA078235 | 16 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule, coated pellets; capsule, extended release; tablet, film coated | ANDAANDA078235, ANDA078877, ANDA207382 | 16 | 1 |
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA076343, ANDA078235, ANDA090162 | 12 | 3 |
| Upsher-Smith Laboratories, Inc. | capsule; capsule, extended release | ANDA, NDA, NDA AUTHORIZED GENERICANDA217694, NDA205122 | 12 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule, coated pellets; capsule, extended release; tablet, film coated | ANDAANDA077627, ANDA210278, ANDA217869 | 11 | 9 |
| Ajanta Pharma LimitedIndia | capsule, extended release | ANDAANDA215663, ANDA219564 | 9 | 2 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA090278 | 8 | 13 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet | ANDAANDA076343, ANDA079162 | 8 | 7 |
| Camber Pharmaceuticals, Inc.United States | capsule, extended release; tablet | ANDAANDA215414, ANDA217443 | 8 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA076343, ANDA078462, ANDA090278 | 8 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078235, ANDA090162 | 8 | 1 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet; tablet, film coated | ANDAANDA076343, ANDA078235, ANDA090162 | 6 | 1 |
| Coupler LLCUnited States | tablet; tablet, film coated | ANDAANDA076343, ANDA078235, ANDA090162 | 6 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, film coated | ANDAANDA076343, ANDA078235, ANDA090162 | 6 | 1 |
| Janssen Pharmaceuticals, Inc. | capsule, coated pellets; tablet, coated | NDANDA020505, NDA020844 | 6 | 0 |
| Northwind Health Company, LLCUnited States | tablet; tablet, film coated | ANDAANDA076343, ANDA077627, ANDA078235 | 5 | 1 |
| NorthStar RxLLC | capsule, extended release | ANDAANDA210278 | 5 | 0 |
| Vitruvias Therapeutics, Inc. | capsule, extended release | ANDAANDA215638 | 5 | 0 |
| Lupin LimitedIndia | capsule, extended release | ANDAANDA215561 | 4 | 14 |
| Aurobindo Pharma LimitedIndia | capsule; tablet, film coated | ANDAANDA078462, ANDA215449 | 4 | 6 |
| Par Health USA, LLCIndia | capsule, extended release | ANDAANDA205976 | 4 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA078235 | 4 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet, film coated | ANDAANDA090162 | 4 | 5 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA076343 | 4 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA078235, ANDA090162 | 4 | 1 |
| Supernus Pharmaceuticals IncUnited States | capsule, extended release | NDANDA201635 | 4 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet | ANDAANDA215414 | 4 | 1 |
| Advanced Rx of Tennessee, LLC | tablet, film coated | ANDAANDA078235, ANDA090162 | 4 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA079162 | 4 | 0 |
| AvKARE | capsule, extended release | ANDAANDA206210 | 4 | 0 |
| AvPAK | tablet, film coated | ANDAANDA078235 | 4 | 0 |
| Dr. Reddys Laboratories Limited | capsule, extended release | ANDAANDA217231 | 4 | 0 |
| Exelan Pharmaceuticals, Inc. | tablet | ANDAANDA079162 | 4 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, extended release | ANDAANDA206210 | 3 | 6 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA078462 | 3 | 1 |
| ASCEND Therapeutics US, LLC | capsule; solution | ANDAANDA217795, ANDA218482 | 3 | 0 |
| Advagen Pharma Limited | capsule | ANDAANDA216683 | 3 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet, film coated | ANDAANDA078235 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA078235 | 2 | 34 |
| Golden State Medical Supply Inc.United States | capsule | ANDAANDA217694 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA078235 | 2 | 0 |
| Kesin Pharma CorporationUnited States | solution | ANDAANDA217795 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | tablet, film coated | ANDAANDA077627 | 1 | 1 |
| Azurity Pharmaceuticals, Inc. | solution | NDANDA214679 | 1 | 0 |
| Pharma-C, Inc. | tablet | ANDAANDA076343 | 1 | 0 |
Bulk ingredient listings
- Hetero Drugs LimitedIndia · 2 NDC
- Willow Birch Pharma, LLCUnited States · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- GLOBAL CALCIUM PRIVATE LIMITEDIndia · 1 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MSN Organics Private LimitedIndia · 1 NDC
- Pharmaceutical Works POLPHARMA · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- SPICA LABORATORIES PRIVATE LIMITEDIndia · 1 NDC
- SciAnda (Changshu) Pharmaceuticals, Ltd.China · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
20 unexpired patents list topiramate as the active ingredient, expiring between Nov 2027 and Aug 2040. Application holders: AZURITY PHARMACEUTICALS INC, SUPERNUS PHARMACEUTICALS INC, UPSHER SMITH LABORATORIES LLC.
Enquiry
Common questions
- Who makes topiramate?
- 48 companies list topiramate as a human prescription drug in the openFDA NDC Directory, led by Proficient Rx LP, Bryant Ranch Prepack, Zydus Lifesciences Limited, RemedyRepack, Inc, Zydus Pharmaceuticals USA Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Eprontia?
- 45 companies list topiramate under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies topiramate active ingredient?
- 24 companies list topiramate as a bulk ingredient, including Hetero Drugs Limited, Willow Birch Pharma, LLC, AX Pharmaceutical Corp, Alivus Life Sciences Limited.