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OmniRx › Tools › Generic competition check › Acalabrutinib Maleate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Acalabrutinib Maleate, and who makes it?

Acalabrutinib Maleate 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.
Acalabrutinib Maleate1 dosage-form group in the Orange Book
0generic makers listed
  1. Acalabrutinib Maleate 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: Calquence. No generic is listed as marketed.

2020202520302035204001brand 2022data datePatent 7459554 listed to expire 24 November 2026Patent 9758524 listed to expire 11 July 2032Patent 10239883 listed to expire 11 July 2032Patent 9290504 listed to expire 11 July 2032Patent 10272083 listed to expire 21 January 2035Patent 11771696 listed to expire 21 January 2035Patent 11166951 listed to expire 11 August 2035Patent 11059829 listed to expire 1 July 2036Exclusivity I-960 to 16 January 2028Exclusivity D-200 to 19 February 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 January 2028Exclusivity I-960 Calquence
  • 19 February 2029Exclusivity D-200 Calquence
  • 24 November 2026Patent 7459554 drug substance
  • 11 July 2032Patent 9758524
  • 11 July 2032Patent 10239883
  • 11 July 2032Patent 9290504 drug substance
  • 21 January 2035Patent 10272083
  • 21 January 2035Patent 11771696
  • 11 August 2035Patent 11166951
  • 1 July 2036Patent 11059829 drug substance

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.