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

Generic competition · all medicines · read 12 November 2026

Is there a generic of Setmelanotide Acetate, and who makes it?

Setmelanotide Acetate 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.
Setmelanotide Acetate1 dosage-form group in the Orange Book
0generic makers listed
  1. Setmelanotide Acetate 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.

Solution, Subcutaneous

Brand listed, no generic listed as marketed

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

202020252030203501brand 2020data datePatent 9458195 listed to expire 13 October 2027Patent 8039435 listed to expire 21 August 2032Patent 11129869 listed to expire 4 July 2034Exclusivity ODE-336 to 25 November 2027Exclusivity NPP to 20 December 2027Exclusivity I-987 to 19 March 2029Exclusivity ODE-402 to 16 June 2029Exclusivity ODE-508 to 20 December 2031Exclusivity ODE-509 to 20 December 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 25 November 2027Exclusivity ODE-336 Imcivree
  • 20 December 2027Exclusivity NPP Imcivree
  • 19 March 2029Exclusivity I-987 Imcivree
  • 16 June 2029Exclusivity ODE-402 Imcivree
  • 20 December 2031Exclusivity ODE-508 Imcivree
  • 20 December 2031Exclusivity ODE-509 Imcivree
  • 13 October 2027Patent 9458195 drug substance
  • 21 August 2032Patent 8039435 drug substance
  • 4 July 2034Patent 11129869 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.