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OmniRx › Tools › Generic competition check › Ivosidenib

Generic competition · all medicines · read 12 November 2026

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

Ivosidenib 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.
Ivosidenib1 dosage-form group in the Orange Book
0generic makers listed
  1. Ivosidenib 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.

Tablet, Oral

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2018data datePatent 10610125 listed to expire 21 June 2030Patent 9850277 listed to expire 18 January 2033Patent 10717764 listed to expire 18 January 2033Patent 11667673 listed to expire 18 January 2033Patent 9474779 listed to expire 19 August 2033Patent 9968595 listed to expire 13 March 2035Patent 10799490 listed to expire 13 March 2035Patent 10449184 listed to expire 13 March 2035Patent 10653710 listed to expire 18 October 2036Patent 10980788 listed to expire 7 June 2039Exclusivity ODE-368 to 25 August 2028Exclusivity ODE-447 to 24 October 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 25 August 2028Exclusivity ODE-368 Tibsovo
  • 24 October 2030Exclusivity ODE-447 Tibsovo
  • 21 June 2030Patent 10610125
  • 18 January 2033Patent 9850277 drug substance
  • 18 January 2033Patent 10717764
  • 18 January 2033Patent 11667673
  • 19 August 2033Patent 9474779 drug substance
  • 13 March 2035Patent 9968595 drug product
  • 13 March 2035Patent 10799490 drug product
  • 13 March 2035Patent 10449184 drug product

2 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.