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OmniRx › Tools › Generic competition check › Avutometinib Potassium; Defactinib Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Avutometinib Potassium; Defactinib Hydrochloride, and who makes it?

Avutometinib Potassium; Defactinib Hydrochloride 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.
Avutometinib Potassium; Defactinib Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Avutometinib Potassium; Defactinib Hydrochloride 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, Tablet, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Avmapki Fakzynja Co-Pack (Copackaged). No generic is listed as marketed.

20202025203020352040204501brand 2025data datePatent 7897792 listed to expire 9 February 2027Patent 8247411 listed to expire 17 April 2028Patent 7928109 listed to expire 21 August 2029Patent 11400090 listed to expire 29 October 2038Patent 11517573 listed to expire 11 September 2040Patent 11873296 listed to expire 29 December 2042Patent 12509450 listed to expire 29 December 2042Exclusivity NCE to 8 May 2030Exclusivity ODE-525 to 8 May 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 8 May 2030Exclusivity NCE Avmapki Fakzynja Co-Pack (Copackaged)
  • 8 May 2032Exclusivity ODE-525 Avmapki Fakzynja Co-Pack (Copackaged)
  • 9 February 2027Patent 7897792 drug substance
  • 17 April 2028Patent 8247411 drug substance
  • 21 August 2029Patent 7928109 drug substance
  • 29 October 2038Patent 11400090
  • 11 September 2040Patent 11517573
  • 29 December 2042Patent 11873296 drug product
  • 29 December 2042Patent 12509450 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.