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

Generic competition · all medicines · read 12 November 2026

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

Pralsetinib 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.
Pralsetinib1 dosage-form group in the Orange Book
0generic makers listed
  1. Pralsetinib 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.

Capsule, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2020data datePatent 10030005 listed to expire 1 November 2036Patent 12655128 listed to expire 1 November 2036Patent 11273160 listed to expire 3 April 2039Patent 12539303 listed to expire 3 April 2039Patent 11872192 listed to expire 3 April 2039Patent 11963958 listed to expire 3 April 2039Patent 12448366 listed to expire 7 July 2042Patent 12692251 listed to expire 19 April 2043Exclusivity ODE-318 to 4 September 2027Exclusivity ODE-340 to 1 December 2027Exclusivity ODE-341 to 1 December 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 4 September 2027Exclusivity ODE-318 Gavreto
  • 1 December 2027Exclusivity ODE-340 Gavreto
  • 1 December 2027Exclusivity ODE-341 Gavreto
  • 1 November 2036Patent 10030005 drug substance
  • 1 November 2036Patent 12655128 drug substance
  • 3 April 2039Patent 11273160
  • 3 April 2039Patent 12539303
  • 3 April 2039Patent 11872192
  • 3 April 2039Patent 11963958
  • 7 July 2042Patent 12448366 drug substance
  • 19 April 2043Patent 12692251 drug product

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.