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OmniRx › Tools › Generic competition check › Entrectinib

Generic competition · all medicines · read 12 November 2026

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

Entrectinib 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. 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.
Entrectinib2 dosage-form groups in the Orange Book
0generic makers listed
  1. Entrectinib 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. 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

Brand listed, no generic listed as marketed

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

20152020202520302035204001brand 2019data datePatent 9616059 listed to expire 8 July 2028Patent 8673893 listed to expire 8 July 2028Patent 9255087 listed to expire 8 July 2028Patent 9029356 listed to expire 8 July 2028Patent 9085558 listed to expire 8 July 2028Patent 8299057 listed to expire 10 March 2032Patent 9649306 listed to expire 22 May 2033Patent 9085565 listed to expire 22 May 2033Patent 10231965 listed to expire 17 February 2035Patent 10561651 listed to expire 19 February 2035Patent 10738037 listed to expire 18 May 2037Patent 11091469 listed to expire 18 May 2037Patent 11253515 listed to expire 18 July 2038Patent 10398693 listed to expire 18 July 2038Exclusivity ODE-448 to 20 October 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 October 2030Exclusivity ODE-448 Rozlytrek
  • 8 July 2028Patent 9616059
  • 8 July 2028Patent 8673893
  • 8 July 2028Patent 9255087
  • 8 July 2028Patent 9029356 drug substance
  • 8 July 2028Patent 9085558 drug product
  • 10 March 2032Patent 8299057 drug substance
  • 22 May 2033Patent 9649306
  • 22 May 2033Patent 9085565 drug substance

6 more patents are listed.

Pellets, Oral

Brand listed, no generic listed as marketed

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

20202025203001brand 2023data dateExclusivity ODE-448 to 20 October 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 20 October 2030Exclusivity ODE-448 Rozlytrek

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.