interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Zanubrutinib

Generic competition · all medicines · read 12 November 2026

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

Zanubrutinib appears in 2 dosage-form groups 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.
Zanubrutinib2 dosage-form groups in the Orange Book
0generic makers listed
  1. Zanubrutinib appears in 2 dosage-form groups 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, Oral

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

201520202025203001brand 2019data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2025data datePatent 11142528 listed to expire 22 April 2034Patent 10570139 listed to expire 22 April 2034Patent 9447106 listed to expire 22 April 2034Patent 11884674 listed to expire 15 August 2037Patent 11591340 listed to expire 15 August 2037Patent 11970500 listed to expire 15 August 2037Patent 10927117 listed to expire 15 August 2037Patent 11851437 listed to expire 15 August 2037Patent 11701357 listed to expire 24 June 2039Patent 12233069 listed to expire 10 June 2040Patent 11896596 listed to expire 19 January 2043Patent 11786531 listed to expire 19 January 2043Patent 11911386 listed to expire 19 January 2043Exclusivity ODE* to 14 November 2026Exclusivity I-936 to 7 March 2027Exclusivity ODE* to 31 August 2028Exclusivity ODE* to 14 September 2028Exclusivity ODE* to 19 January 2030Exclusivity ODE* to 7 March 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 14 November 2026Exclusivity ODE* Brukinsa
  • 7 March 2027Exclusivity I-936 Brukinsa
  • 31 August 2028Exclusivity ODE* Brukinsa
  • 14 September 2028Exclusivity ODE* Brukinsa
  • 19 January 2030Exclusivity ODE* Brukinsa
  • 7 March 2031Exclusivity ODE* Brukinsa
  • 22 April 2034Patent 11142528 drug product
  • 22 April 2034Patent 10570139
  • 22 April 2034Patent 9447106 drug substance
  • 15 August 2037Patent 11884674
  • 15 August 2037Patent 11591340
  • 15 August 2037Patent 11970500
  • 15 August 2037Patent 10927117 drug substance
  • 15 August 2037Patent 11851437 drug substance

5 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.