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OmniRx › Tools › Generic competition check › Olutasidenib

Generic competition · all medicines · read 12 November 2026

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

Olutasidenib appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 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. 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.
Olutasidenib1 dosage-form group in the Orange Book
0generic makers listed
  1. Olutasidenib appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  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. 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.

Capsule, Oral

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2022data datePatent 9834539 listed to expire 18 September 2035Patent 12275715 listed to expire 18 September 2035Patent 10414752 listed to expire 18 September 2035Patent 10550098 listed to expire 18 September 2035Patent 11498913 listed to expire 18 September 2035Patent 11497743 listed to expire 16 May 2039Patent 11376246 listed to expire 16 May 2039Patent 11013734 listed to expire 16 May 2039Patent 11013733 listed to expire 16 May 2039Patent 10532047 listed to expire 16 May 2039Patent 12053463 listed to expire 16 May 2039Patent 10959994 listed to expire 16 May 2039Patent 11738018 listed to expire 17 July 2039Patent 11723905 listed to expire 12 November 2039Exclusivity NCE to 1 December 2027Exclusivity ODE-413 to 1 December 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 1 December 2027Exclusivity NCE Rezlidhia
  • 1 December 2029Exclusivity ODE-413 Rezlidhia
  • 18 September 2035Patent 9834539 drug substance
  • 18 September 2035Patent 12275715 drug substance
  • 18 September 2035Patent 10414752 drug product
  • 18 September 2035Patent 10550098 drug product
  • 18 September 2035Patent 11498913 drug product
  • 16 May 2039Patent 11497743
  • 16 May 2039Patent 11376246
  • 16 May 2039Patent 11013734

6 more patents are listed.

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.