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Generic competition · all medicines · read 12 November 2026

Is there a generic of Asciminib Hydrochloride, and who makes it?

Asciminib 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.
Asciminib Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Asciminib 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.

Tablet, Oral

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2021data datePatent 8829195 listed to expire 29 October 2035Patent 12252478 listed to expire 14 May 2040Patent 11407735 listed to expire 14 May 2040Patent 12252479 listed to expire 17 May 2040Exclusivity I-953 to 29 October 2027Exclusivity I-954 to 29 October 2027Exclusivity M-318 to 2 October 2028Exclusivity ODE-381 to 29 October 2028Exclusivity ODE-382 to 29 October 2028Exclusivity ODE* to 29 October 2028Exclusivity ODE-499 to 29 October 2031Exclusivity ODE-500 to 29 October 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 29 October 2027Exclusivity I-953 Scemblix
  • 29 October 2027Exclusivity I-954 Scemblix
  • 2 October 2028Exclusivity M-318 Scemblix
  • 29 October 2028Exclusivity ODE-381 Scemblix
  • 29 October 2028Exclusivity ODE-382 Scemblix
  • 29 October 2028Exclusivity ODE* Scemblix
  • 29 October 2035Patent 8829195 drug substance
  • 14 May 2040Patent 12252478 drug product
  • 14 May 2040Patent 11407735 drug substance
  • 17 May 2040Patent 12252479

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.