Generic competition · all medicines · read 12 November 2026
Is there a generic of Vigabatrin, and who makes it?
Vigabatrin appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 7.7 and 9.4 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Vigabatrin appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 16 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 7.7 and 9.4 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
For Solution, Oral
Four or more generic makers listed
Brand listed as marketed: Sabril. 10 generic makers with 10 generic products listed as marketed; the first generic approval is dated 27 April 2017.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ph Health Ltd | 27 April 2017 | 1 |
| Amneal Pharmaceuticals Of New York Llc | 13 March 2018 | 1 |
| Bora Pharmaceutical Holdings Llc | 21 June 2018 | 1 |
| Dr Reddys Laboratories Ltd | 20 November 2018 | 1 |
| Invagen Pharmaceuticals Inc | 3 December 2019 | 1 |
| Alkem Laboratories Ltd | 2 December 2020 | 1 |
| Annora Pharma Private Ltd | 26 January 2021 | 1 |
| Aurobindo Pharma Ltd | 29 September 2021 | 1 |
| Pyros Pharmaceuticals Inc | 24 June 2022 | 1 |
| Msn Laboratories Private Ltd | 7 September 2022 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Sabril. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 14 January 2019.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Teva Pharmaceuticals Usa | 14 January 2019 | 1 |
| Dr Reddys Laboratories Ltd | 29 January 2021 | 1 |
| Dexcel Pharma Technologies Ltd | 23 September 2021 | 1 |
| Zydus Lifesciences Global Fze | 19 January 2022 | 1 |
| Aurobindo Pharma Ltd | 10 May 2022 | 1 |
| Hikma Pharmaceuticals Usa Inc | 29 August 2022 | 1 |
| Carnegie Pharmaceuticals Llc | 28 April 2023 | 1 |
| Upsher Smith Laboratories Llc | 29 June 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Vigafyde. No generic is listed as marketed.
Patents and exclusivities still listed
- 16 August 2039Patent 12016857 drug product
- 17 October 2042Patent 12290499 drug product
- 8 June 2043Patent 12576054 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.