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OmniRx › Tools › Generic competition check › Imatinib Mesylate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Imatinib Mesylate, and who makes it?

Imatinib Mesylate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 12.6 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.
Imatinib Mesylate3 dosage-form groups in the Orange Book
12generic makers listed
  1. Imatinib Mesylate appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 12 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 12.6 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: Gleevec. 12 generic makers with 24 generic products listed as marketed; the first generic approval is dated 3 December 2015.

2000200520102015202020252030012brand 2003Teva Pharmaceuticals Usa, first approval 4 August 2016Apotex Inc, first approval 5 August 2016Mylan Pharmaceuticals Inc, first approval 21 June 2017Dr Reddys Laboratories Ltd, first approval 13 August 2018Chartwell Rx Sciences Llc, first approval 17 January 2019Shilpa Medicare Ltd, first approval 17 January 2019Natco Pharma Ltd, first approval 1 March 2019Zydus Pharmaceuticals Usa Inc, first approval 8 April 2020Eugia Pharma Specialities Ltd, first approval 23 July 2020Qilu Pharmaceutical Hainan Co Ltd, first approval 21 June 2022Hetero Labs Ltd Unit V, first approval 14 April 2025Cspc Ouyi Pharmaceutical Co Ltd, first approval 21 April 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Teva Pharmaceuticals Usa4 August 20162
Apotex Inc5 August 20162
Mylan Pharmaceuticals Inc21 June 20172
Dr Reddys Laboratories Ltd13 August 20182
Chartwell Rx Sciences Llc17 January 20192
Shilpa Medicare Ltd17 January 20192
Natco Pharma Ltd1 March 20192
Zydus Pharmaceuticals Usa Inc8 April 20202
Eugia Pharma Specialities Ltd23 July 20202
Qilu Pharmaceutical Hainan Co Ltd21 June 20222
Hetero Labs Ltd Unit V14 April 20252
Cspc Ouyi Pharmaceutical Co Ltd21 April 20252

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Capsule, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

200020052010201520202025203001brand 2001data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Imkeldi. No generic is listed as marketed.

2020202520302035204001brand 2024data datePatent 11957681 listed to expire 27 April 2040
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 27 April 2040Patent 11957681 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.