Generic competition · all medicines · read 12 November 2026
Is there a generic of Ketorolac Tromethamine, and who makes it?
Ketorolac Tromethamine appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 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 5.4 and 17 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.
- Ketorolac Tromethamine appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 23 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 5.4 and 17 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.
Injectable, Injection
Four or more generic makers listed
Every brand product here is listed as discontinued. 14 generic makers with 26 generic products listed as marketed; the first generic approval is dated 5 June 1997.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hospira Inc | 5 June 1997 | 2 |
| Fresenius Kabi Usa Llc | 11 January 2002 | 3 |
| Hikma Pharmaceuticals Usa Inc | 21 July 2004 | 2 |
| Sandoz Inc | 6 October 2004 | 1 |
| Apotex Inc | 27 March 2007 | 2 |
| Sagent Pharmaceuticals Inc | 27 November 2013 | 2 |
| Gland Pharma Ltd | 1 November 2016 | 2 |
| Baxter Healthcare Corp | 15 September 2017 | 2 |
| Nephron Pharmaceuticals Corporation | 20 August 2020 | 1 |
| Alembic Pharmaceuticals Ltd | 2 November 2022 | 2 |
| Caplin Steriles Ltd | 10 May 2023 | 2 |
| Aspiro Pharma Ltd | 20 June 2023 | 2 |
2 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Solution/Drops, Ophthalmic
Four or more generic makers listed
Brand listed as marketed: Acular, Acular Ls and Acuvail. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 5 November 2009.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Apotex Inc | 5 November 2009 | 1 |
| Sandoz Inc | 5 November 2009 | 1 |
| Micro Labs Ltd India | 5 April 2019 | 1 |
| Caplin Steriles Ltd | 26 March 2024 | 1 |
Patents and exclusivities still listed
- 24 May 2027Patent 8008338 drug substance
- 24 November 2027Patent 8008338*PED
- 7 March 2028Patent 8512717 drug product
- 7 March 2028Patent 9192571 drug product
- 15 August 2029Patent 7842714 drug substance
Tablet, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 16 May 1997.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Mylan Pharmaceuticals Inc | 16 May 1997 | 1 |
| Teva Pharmaceuticals Usa Inc | 16 May 1997 | 1 |
| Chartwell Rx Sciences Llc | 16 August 2018 | 1 |
| Pharmazone | 23 March 2022 | 1 |
| Hetero Labs Ltd Unit Iii | 25 August 2022 | 1 |
| Zydus Lifesciences Global Fze | 21 October 2022 | 1 |
| Bionpharma Inc | 23 February 2023 | 1 |
| Leading Pharma Llc | 23 February 2023 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Spray, Metered, Nasal
Brand listed, no generic listed as marketed
Brand listed as marketed: Sprix. 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.