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Generic competition · all medicines · read 12 November 2026

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

Avapritinib 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.
Avapritinib1 dosage-form group in the Orange Book
0generic makers listed
  1. Avapritinib 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: Ayvakit. No generic is listed as marketed.

20202025203020352040204501brand 2020data datePatent 9200002 listed to expire 15 October 2034Patent 9944651 listed to expire 15 October 2034Patent 9994575 listed to expire 15 October 2034Patent 11827642 listed to expire 15 October 2034Patent 11999744 listed to expire 10 April 2040Patent 12252494 listed to expire 10 April 2040Patent 11964980 listed to expire 10 April 2040Patent 12060354 listed to expire 8 March 2042Exclusivity ODE-366 to 9 January 2027Exclusivity ODE-356 to 16 June 2028Exclusivity ODE-434 to 22 May 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 9 January 2027Exclusivity ODE-366 Ayvakit
  • 16 June 2028Exclusivity ODE-356 Ayvakit
  • 22 May 2030Exclusivity ODE-434 Ayvakit
  • 15 October 2034Patent 9200002 drug substance
  • 15 October 2034Patent 9944651 drug substance
  • 15 October 2034Patent 9994575 drug substance
  • 15 October 2034Patent 11827642 drug substance
  • 10 April 2040Patent 11999744
  • 10 April 2040Patent 12252494
  • 10 April 2040Patent 11964980 drug substance
  • 8 March 2042Patent 12060354

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.