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OmniRx › Tools › Generic competition check › Azacitidine

Generic competition · all medicines · read 12 November 2026

Is there a generic of Azacitidine, and who makes it?

Azacitidine appears in 2 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 9.3 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.
Azacitidine2 dosage-form groups in the Orange Book
12generic makers listed
  1. Azacitidine appears in 2 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 9.3 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.

Powder, Intravenous, Subcutaneous

Four or more generic makers listed

Brand listed as marketed: Azacitidine and Vidaza. 12 generic makers with 12 generic products listed as marketed; the first generic approval is dated 16 September 2013.

2000200520102015202020252030012brand 2004Dr Reddys Laboratories Ltd, first approval 16 September 2013Adaptis Pharma Private Ltd, first approval 29 September 2016Natco Pharma Ltd, first approval 23 June 2017Cipla Ltd, first approval 4 May 2018Accord Healthcare Inc, first approval 2 July 2018Eurohealth International Sarl, first approval 8 June 2020Meitheal Pharmaceuticals Inc, first approval 2 November 2020Eugia Pharma Specialities Ltd, first approval 30 December 2022Jiangsu Hansoh Pharmaceutical Group Co Ltd, first approval 28 June 2023Msn Laboratories Private Ltd, first approval 16 May 2024Hetero Labs Ltd Unit Vi, first approval 15 October 2024Somerset Therapeutics Llc, first approval 20 May 2025data dateExclusivity ODE-399 to 20 May 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Dr Reddys Laboratories Ltd16 September 20131
Adaptis Pharma Private Ltd29 September 20161
Natco Pharma Ltd23 June 20171
Cipla Ltd4 May 20181
Accord Healthcare Inc2 July 20181
Eurohealth International Sarl8 June 20201
Meitheal Pharmaceuticals Inc2 November 20201
Eugia Pharma Specialities Ltd30 December 20221
Jiangsu Hansoh Pharmaceutical Group Co Ltd28 June 20231
Msn Laboratories Private Ltd16 May 20241
Hetero Labs Ltd Unit Vi15 October 20241
Somerset Therapeutics Llc20 May 20251

Patents and exclusivities still listed

  • 20 May 2029Exclusivity ODE-399 Vidaza

Tablet, Oral

Brand listed, no generic listed as marketed

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

20202025203001brand 2020data datePatent 12053482 listed to expire 14 May 2029Patent 11571436 listed to expire 14 May 2029Patent 8846628 listed to expire 3 June 2030Exclusivity ODE-320 to 1 September 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 September 2027Exclusivity ODE-320 Onureg
  • 14 May 2029Patent 12053482
  • 14 May 2029Patent 11571436 drug product
  • 3 June 2030Patent 8846628 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.