Generic competition · all medicines · read 12 November 2026
Is there a generic of Indomethacin, and who makes it?
Indomethacin appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 1.2 and 8 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.
- Indomethacin appears in 5 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 15 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 1.2 and 8 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.
Capsule, Oral
Four or more generic makers listed
Brand listed as marketed: Indomethacin. 5 generic makers with 9 generic products listed as marketed; the first generic approval is dated 18 June 1985.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Chartwell Molecules Llc | 5 March 1986 | 1 |
| Sandoz Inc | 29 April 1987 | 2 |
| Zydus Lifesciences Ltd | 15 November 2010 | 2 |
| Glenmark Pharmaceuticals Ltd | 22 December 2010 | 2 |
| Hetero Labs Ltd Unit Iii | 12 April 2011 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Capsule, Extended Release, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 7 generic makers with 7 generic products listed as marketed; the first generic approval is dated 15 March 1989.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Avanthi Inc | 6 March 2009 | 1 |
| Chartwell Rx Sciences Llc | 30 November 2010 | 1 |
| Amneal Pharmaceuticals | 1 December 2010 | 1 |
| Hetero Labs Ltd Unit Iii | 28 September 2012 | 1 |
| Novast Laboratories Ltd | 8 May 2017 | 1 |
| Glenmark Pharmaceuticals Ltd | 22 June 2017 | 1 |
| Zydus Pharmaceuticals Usa Inc | 25 September 2017 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suppository, Rectal
Four or more generic makers listed
Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 31 August 1992.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Cosette Pharmaceuticals Inc | 31 August 1992 | 1 |
| Zydus Lifesciences Global Fze | 2 August 2023 | 1 |
| Hikma Pharmaceuticals Usa Inc | 19 November 2024 | 1 |
| Amneal Pharmaceuticals Llc | 24 February 2025 | 1 |
| Annora Pharma Private Ltd | 3 July 2025 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
One to three generic makers listed
Brand listed as marketed: Indocin. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 18 March 1987.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Novitium Pharma Llc | 12 January 2024 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Injectable, Injection
Brand listed, no generic listed as marketed
Brand listed as marketed: Indomethacin. No generic is listed as marketed.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
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.