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OmniRx › Tools › Generic competition check › Paltusotine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Paltusotine Hydrochloride, and who makes it?

Paltusotine Hydrochloride 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.
Paltusotine Hydrochloride1 dosage-form group in the Orange Book
0generic makers listed
  1. Paltusotine Hydrochloride 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.

Tablet, Oral

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2025data datePatent 11414397 listed to expire 12 July 2037Patent 10875839 listed to expire 12 July 2037Patent 10597377 listed to expire 12 July 2037Patent 10351547 listed to expire 12 July 2037Patent 9896432 listed to expire 12 July 2037Patent 10464918 listed to expire 16 January 2039Patent 11957674 listed to expire 7 September 2041Patent 11266641 listed to expire 7 September 2041Patent 12208092 listed to expire 25 March 2044Exclusivity NCE to 25 September 2030Exclusivity ODE-537 to 25 September 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 25 September 2030Exclusivity NCE Palsonify
  • 25 September 2032Exclusivity ODE-537 Palsonify
  • 12 July 2037Patent 11414397 drug substance
  • 12 July 2037Patent 10875839
  • 12 July 2037Patent 10597377 drug substance
  • 12 July 2037Patent 10351547 drug substance
  • 12 July 2037Patent 9896432 drug substance
  • 16 January 2039Patent 10464918 drug substance
  • 7 September 2041Patent 11957674
  • 7 September 2041Patent 11266641 drug product

1 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.