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OmniRx › Tools › Generic competition check › Palovarotene

Generic competition · all medicines · read 12 November 2026

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

Palovarotene 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.
Palovarotene1 dosage-form group in the Orange Book
0generic makers listed
  1. Palovarotene 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: Sohonos. No generic is listed as marketed.

2020202520302035204001brand 2023data datePatent 10292954 listed to expire 31 August 2031Patent 9789074 listed to expire 31 August 2031Patent 9314439 listed to expire 31 August 2031Patent 12023312 listed to expire 31 August 2031Patent 11622959 listed to expire 8 June 2037Patent 12458626 listed to expire 8 June 2037Patent 12138245 listed to expire 8 June 2037Patent 12201614 listed to expire 8 June 2037Patent 10864194 listed to expire 16 August 2037Exclusivity NCE to 16 August 2028Exclusivity ODE-439 to 16 August 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 16 August 2028Exclusivity NCE Sohonos
  • 16 August 2030Exclusivity ODE-439 Sohonos
  • 31 August 2031Patent 10292954
  • 31 August 2031Patent 9789074
  • 31 August 2031Patent 9314439
  • 31 August 2031Patent 12023312
  • 8 June 2037Patent 11622959
  • 8 June 2037Patent 12458626
  • 8 June 2037Patent 12138245
  • 8 June 2037Patent 12201614

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.