Indomethacin
As of the edition of 20 October 2026, Indomethacin is a small molecule: marketed, first approved in 1965 (ES); acts on PTGS1 and PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Indocin
- First approved
- 1 March 1965 (ES)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- Genus Lifesciences; 15 holders in all
- Registered trials
- 106, 11 stopped early
- Disease areas
- Digestive system; Urinary and reproductive; Cancer; Pregnancy and women's health; Heart and blood vessels; Inherited and neonatal
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Indomethacin.
See the 3 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 23 | 9 | 6 | 2 |
| Phase 1 | 16 | 11 | 1 | 3 |
| Phase 2 | 26 | 12 | 3 | 4 |
| Phase 3 | 21 | 12 | 3 | 1 |
| Phase 4 | 20 | 13 | 4 | 1 |
| All trials | 106 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Viatris | Later holder | 1984 to now |
| Pfizer | Later holder | 1984 to now |
| Lundbeck | Later holder | 1984 to now |
| Actavis | Acquired holder | 2003 to now |
| Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals | Acquired holder | 2009 to now |
| Iroko Pharmaceuticals | Later holder and Lead sponsor of trials | 2009 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Recordati Rare Diseases | Acquired holder | 2013 to now |
| Chartwell Molecules | Acquired holder | 2017 to now |
| Genus Lifesciences | Acquired holder | 2019 to now |
| Avet Pharmaceuticals | Acquired holder | 2020 to now |
| Rising Pharma | Acquired holder | 2022 to now |
| Zydus Worldwide DMCC | Acquired holder | 2023 to now |
| Cosette Pharmaceuticals | Acquired holder | 2026 to now |
| Merck & Co. | Earlier holder |