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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.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Colchicine3 dosage-form groups in the Orange Book
14generic makers listed
  1. 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.
  2. 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.
  3. Where both are dated, the first generic approval came between 4.2 and 7.2 years after the first brand approval.
  4. 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.

2005201020152020202520302035012brand 2009Amneal Pharmaceuticals, first approval 28 September 2016Alkem Laboratories Ltd, first approval 8 February 2019Zydus Pharmaceuticals Usa Inc, first approval 19 February 2019Watson Laboratories Inc, first approval 31 July 2019Dr Reddys Laboratories Ltd, first approval 6 September 2019Mylan Pharmaceuticals Inc, first approval 16 September 2019Granules Pharmaceuticals Inc, first approval 5 February 2020Ph Health Ltd, first approval 12 August 2021Hetero Labs Ltd Unit V, first approval 13 August 2021Aurobindo Pharma Ltd, first approval 6 January 2022Strides Pharma Global Pte Ltd, first approval 10 March 2022Macleods Pharmaceuticals Ltd, first approval 13 February 2026data datePatent 12364675 listed to expire 1 November 2033Patent 12233035 listed to expire 1 November 2033Patent 11026901 listed to expire 1 November 2033Patent 11026900 listed to expire 1 November 2033Patent 11026899 listed to expire 1 November 2033Patent 10842762 listed to expire 1 November 2033Patent 10265281 listed to expire 1 November 2033Patent 10206891 listed to expire 1 November 2033Patent 9744144 listed to expire 1 November 2033Patent 11944594 listed to expire 1 November 2033Patent 12280025 listed to expire 1 November 2033Patent 11944595 listed to expire 1 November 2033Patent 10130585 listed to expire 9 May 2034
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Amneal Pharmaceuticals28 September 20161
Alkem Laboratories Ltd8 February 20191
Zydus Pharmaceuticals Usa Inc19 February 20192
Watson Laboratories Inc31 July 20191
Dr Reddys Laboratories Ltd6 September 20191
Mylan Pharmaceuticals Inc16 September 20191
Granules Pharmaceuticals Inc5 February 20201
Ph Health Ltd12 August 20211
Hetero Labs Ltd Unit V13 August 20211
Aurobindo Pharma Ltd6 January 20221
Strides Pharma Global Pte Ltd10 March 20221
Macleods Pharmaceuticals Ltd13 February 20261

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.

20102015202020252030203505brand 2014Ph Health Ltd, first approval 29 November 2018Annora Pharma Private Ltd, first approval 29 April 2024Aurobindo Pharma Ltd, first approval 29 April 2024Granules Pharmaceuticals Inc, first approval 29 April 2024Micro Labs Ltd, first approval 17 February 2026data datePatent 9555029 listed to expire 22 August 2033Patent 9789108 listed to expire 22 August 2033Patent 9675613 listed to expire 22 August 2033Patent 8927607 listed to expire 22 August 2033Patent 9399036 listed to expire 22 August 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ph Health Ltd29 November 20181
Annora Pharma Private Ltd29 April 20241
Aurobindo Pharma Ltd29 April 20241
Granules Pharmaceuticals Inc29 April 20241
Micro Labs Ltd17 February 20261

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.

20152020202520302035204001brand 2019data datePatent 12274751 listed to expire 22 November 2036Patent 12514819 listed to expire 22 November 2036Patent 10383820 listed to expire 22 November 2036Patent 10383821 listed to expire 22 November 2036Patent 9907751 listed to expire 22 November 2036Patent 10226423 listed to expire 20 December 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

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.