Generic competition · all medicines · read 12 November 2026

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

Ibrutinib appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them. 2 groups have 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. Where both are dated, the first generic approval came 7.4 years after the first brand approval. 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.

Ibrutinib3 dosage-form groups in the Orange Book

1generic maker listed

Ibrutinib appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 1 generic maker listed as marketed across them.
2 groups have 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.
Where both are dated, the first generic approval came 7.4 years after the first brand approval.
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

One to three generic makers listed

Brand listed as marketed: Imbruvica. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 31 March 2021.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Generic maker (applicant)	First approval	Products
Hetero Labs Ltd Unit V	8 September 2026	1

Patents and exclusivities still listed

24 August 2029Exclusivity ODE-405 Imbruvica
24 February 2030Exclusivity PED Imbruvica
28 December 2026Patent 8952015
28 December 2026Patent 8497277
28 December 2026Patent 8703780
28 December 2026Patent 8476284
28 December 2026Patent 8735403 drug substance
28 December 2026Patent 7514444 drug substance
28 December 2026Patent 8957079 drug substance
28 December 2026Patent 9181257 drug substance

59 more patents are listed.

Tablet, Oral

Brand listed, no generic listed as marketed

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

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

24 August 2029Exclusivity ODE-405 Imbruvica
24 February 2030Exclusivity PED Imbruvica
28 December 2026Patent 8476284
28 December 2026Patent 8497277
28 December 2026Patent 8703780
28 December 2026Patent 8952015
28 December 2026Patent 8754091 drug product
28 December 2026Patent 7514444 drug substance
28 December 2026Patent 8697711 drug substance
28 December 2026Patent 8957079 drug substance

60 more patents are listed.

Suspension, Oral

Brand listed, no generic listed as marketed

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

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

24 August 2029Exclusivity ODE-405 Imbruvica
24 February 2030Exclusivity PED Imbruvica
28 December 2026Patent 8703780
28 December 2026Patent 8952015
28 December 2026Patent 8476284
28 December 2026Patent 8497277
28 December 2026Patent 8957079 drug substance
28 December 2026Patent 8735403 drug substance
28 December 2026Patent 9181257 drug substance
28 December 2026Patent 8754091 drug product

38 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.