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OmniRx › Tools › Generic competition check › Palbociclib

Generic competition · all medicines · read 12 November 2026

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

Palbociclib appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 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 4.6 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.
Palbociclib2 dosage-form groups in the Orange Book
0generic makers listed
  1. Palbociclib appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
  2. 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.
  3. Where both are dated, the first generic approval came 4.6 years after the first brand approval.
  4. 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: Ibrance. No generic is listed as marketed (3 generic products listed as discontinued).

20152020202520302035204001brand 2019data datePatent RE47739 listed to expire 5 March 2027Patent RE47739*PED listed to expire 5 September 2027Patent 10723730 listed to expire 8 February 2034Patent 10723730*PED listed to expire 8 August 2034Patent 11065250 listed to expire 19 August 2036Patent 11065250*PED listed to expire 19 February 2037Exclusivity M-14 to 16 September 2028Exclusivity PED to 16 March 2029Exclusivity I-995 to 24 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 September 2028Exclusivity M-14 Ibrance
  • 16 March 2029Exclusivity PED Ibrance
  • 24 June 2029Exclusivity I-995 Ibrance
  • 5 March 2027Patent RE47739 drug substance
  • 5 September 2027Patent RE47739*PED
  • 8 February 2034Patent 10723730 drug substance
  • 8 August 2034Patent 10723730*PED
  • 19 August 2036Patent 11065250 drug product
  • 19 February 2037Patent 11065250*PED

Capsule, Oral

Brand listed, no generic listed as marketed

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

2015202020252030203501brand 2015data datePatent RE47739 listed to expire 5 March 2027Patent RE47739*PED listed to expire 5 September 2027Patent 10723730 listed to expire 8 February 2034Patent 10723730*PED listed to expire 8 August 2034Exclusivity M-14 to 16 September 2028Exclusivity PED to 16 March 2029Exclusivity I-995 to 24 June 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 September 2028Exclusivity M-14 Ibrance
  • 16 March 2029Exclusivity PED Ibrance
  • 24 June 2029Exclusivity I-995 Ibrance
  • 5 March 2027Patent RE47739 drug substance
  • 5 September 2027Patent RE47739*PED
  • 8 February 2034Patent 10723730 drug substance
  • 8 August 2034Patent 10723730*PED

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.