Drug
Who makes vigabatrin?
16 companies list vigabatrin as a human prescription drug, including under the names SABRIL, VIGADRONE, VIGAFYDE. Forms: for solution; powder, for solution; solution; tablet; 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 vigabatrin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | for solution; tablet | ANDAANDA210042, ANDA210155 | 3 | 0 |
| Upsher-Smith Laboratories, Inc. | powder, for solution; solution; tablet | ANDA, NDAANDA210196, ANDA214749, NDA217684 | 3 | 0 |
| Zydus Lifesciences LimitedIndia | powder, for solution; tablet, film coated | ANDAANDA214671, ANDA215707 | 2 | 12 |
| Aurobindo Pharma LimitedIndia | powder, for solution; tablet | ANDAANDA213899, ANDA215601 | 2 | 6 |
| Lundbeck Pharmaceuticals LLCDenmark | powder, for solution; tablet, film coated | NDANDA020427, NDA022006 | 2 | 5 |
| Zydus Pharmaceuticals USA Inc.India | powder, for solution; tablet, film coated | ANDAANDA214671, ANDA215707 | 2 | 1 |
| Dr. Reddys Laboratories Limited | powder, for solution; tablet, film coated | ANDAANDA211481, ANDA211539 | 2 | 0 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | powder, for solution | ANDAANDA211592 | 1 | 7 |
| Par Health USA, LLCIndia | powder, for solution | ANDAANDA208218 | 1 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA213104 | 1 | 4 |
| Actavis LLCUnited States | tablet, film coated | ANDAANDA209822 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | powder, for solution | ANDAANDA213519 | 1 | 1 |
| Carnegie Pharmaceuticals, LLCUnited States | tablet, film coated | ANDAANDA215519 | 1 | 1 |
| ASCEND Therapeutics US, LLC | powder, for solution | ANDAANDA213375 | 1 | 0 |
| Edenbridge Pharmaceuticals LLC. | tablet | ANDAANDA215109 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | for solution | ANDAANDA215363 | 1 | 0 |
Bulk ingredient listings
- Aurobindo Pharma LimitedIndia · 1 NDC
- DIVI'S LABORATORIES LIMITEDIndia · 1 NDC
- Granules Pharmaceuticals Inc.India · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Olon USA LLCItaly · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
Orange Book patents
3 unexpired patents list vigabatrin as the active ingredient, expiring between Aug 2039 and Jun 2043. Application holder: PYROS PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes vigabatrin?
- 16 companies list vigabatrin as a human prescription drug in the openFDA NDC Directory, led by Amneal Pharmaceuticals NY LLC, Upsher-Smith Laboratories, Inc., Zydus Lifesciences Limited, Aurobindo Pharma Limited, Lundbeck Pharmaceuticals LLC. 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 SABRIL?
- 15 companies list vigabatrin under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies vigabatrin active ingredient?
- 9 companies list vigabatrin as a bulk ingredient, including Aurobindo Pharma Limited, DIVI'S LABORATORIES LIMITED, Granules Pharmaceuticals Inc., Hetero Drugs Limited.