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OmniRx › Tools › Generic competition check › Mitomycin

Generic competition · all medicines · read 12 November 2026

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

Mitomycin appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 generic makers listed as marketed across them. 3 groups have 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. 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.
Mitomycin4 dosage-form groups in the Orange Book
6generic makers listed
  1. Mitomycin appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 generic makers listed as marketed across them.
  2. 3 groups have 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. 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. 6 generic makers with 19 generic products listed as marketed; the first generic approval is dated 10 March 1988.

1995200020052010201520202025203006brand 2002Hikma Pharmaceuticals Usa Inc, first approval 19 April 1995Accord Healthcare Inc, first approval 30 April 1998Adaptis Pharma Private Ltd, first approval 13 October 2017Gland Pharma Ltd, first approval 20 October 2021Meitheal Pharmaceuticals Inc, first approval 6 September 2022Fresenius Kabi Usa Llc, first approval 5 April 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc19 April 19954
Accord Healthcare Inc30 April 19983
Adaptis Pharma Private Ltd13 October 20173
Gland Pharma Ltd20 October 20213
Meitheal Pharmaceuticals Inc6 September 20223
Fresenius Kabi Usa Llc5 April 20243

Patents and exclusivities still listed

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

For Solution, Topical

Brand listed, no generic listed as marketed

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

2010201520202025203001brand 2012data datePatent 9539241 listed to expire 2 January 2028Patent 7806265 listed to expire 1 February 2029Patent 9649428 listed to expire 21 May 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 2 January 2028Patent 9539241 drug substance
  • 1 February 2029Patent 7806265 drug product
  • 21 May 2029Patent 9649428

Powder, Intravesical

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2025data datePatent 10039832 listed to expire 20 January 2031Patent 9950069 listed to expire 20 January 2031Patent 9040074 listed to expire 20 January 2031Patent 12440568 listed to expire 20 January 2031Patent 12740940 listed to expire 25 July 2044Exclusivity NP to 12 June 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 12 June 2028Exclusivity NP Zusduri
  • 20 January 2031Patent 10039832
  • 20 January 2031Patent 9950069 drug product
  • 20 January 2031Patent 9040074 drug product
  • 20 January 2031Patent 12440568
  • 25 July 2044Patent 12740940

Powder, Pyelocalyceal

Brand listed, no generic listed as marketed

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

202020252030203501brand 2020data datePatent 12268745 listed to expire 20 January 2031Patent 9950069 listed to expire 20 January 2031Patent 9040074 listed to expire 20 January 2031Exclusivity ODE-289 to 15 April 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 April 2027Exclusivity ODE-289 Jelmyto
  • 20 January 2031Patent 12268745
  • 20 January 2031Patent 9950069 drug product
  • 20 January 2031Patent 9040074 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.