Generic competition · all medicines · read 12 November 2026
Is there a generic of Colchicine, and who makes it?
Colchicine appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 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 4.2 and 7.2 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.
- Colchicine appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 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 4.2 and 7.2 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.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Lodoco. 12 generic makers with 13 generic products listed as marketed; the first generic approval is dated 28 September 2016.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Amneal Pharmaceuticals | 28 September 2016 | 1 |
| Alkem Laboratories Ltd | 8 February 2019 | 1 |
| Zydus Pharmaceuticals Usa Inc | 19 February 2019 | 2 |
| Watson Laboratories Inc | 31 July 2019 | 1 |
| Dr Reddys Laboratories Ltd | 6 September 2019 | 1 |
| Mylan Pharmaceuticals Inc | 16 September 2019 | 1 |
| Granules Pharmaceuticals Inc | 5 February 2020 | 1 |
| Ph Health Ltd | 12 August 2021 | 1 |
| Hetero Labs Ltd Unit V | 13 August 2021 | 1 |
| Aurobindo Pharma Ltd | 6 January 2022 | 1 |
| Strides Pharma Global Pte Ltd | 10 March 2022 | 1 |
| Macleods Pharmaceuticals Ltd | 13 February 2026 | 1 |
Patents and exclusivities still listed
- 1 November 2033Patent 12364675
- 1 November 2033Patent 12233035
- 1 November 2033Patent 11026901
- 1 November 2033Patent 11026900
- 1 November 2033Patent 11026899
- 1 November 2033Patent 10842762
- 1 November 2033Patent 10265281
- 1 November 2033Patent 10206891
5 more patents are listed.
Capsule, Oral
Four or more generic makers listed
Brand listed as marketed: Mitigare. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 29 November 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Ph Health Ltd | 29 November 2018 | 1 |
| Annora Pharma Private Ltd | 29 April 2024 | 1 |
| Aurobindo Pharma Ltd | 29 April 2024 | 1 |
| Granules Pharmaceuticals Inc | 29 April 2024 | 1 |
| Micro Labs Ltd | 17 February 2026 | 1 |
Patents and exclusivities still listed
- 22 August 2033Patent 9555029
- 22 August 2033Patent 9789108
- 22 August 2033Patent 9675613
- 22 August 2033Patent 8927607
- 22 August 2033Patent 9399036
Solution, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Gloperba. No generic is listed as marketed.
Patents and exclusivities still listed
- 22 November 2036Patent 12274751
- 22 November 2036Patent 12514819
- 22 November 2036Patent 10383820 drug product
- 22 November 2036Patent 10383821 drug product
- 22 November 2036Patent 9907751 drug product
- 20 December 2037Patent 10226423 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.