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OmniRx › Tools › Generic competition check › Elamipretide Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

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

Solution, Subcutaneous

Brand listed, no generic listed as marketed

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

202020252030203501brand 2025data datePatent 7576061 listed to expire 20 January 2027Patent 12268724 listed to expire 28 February 2034Patent 11771734 listed to expire 28 February 2034Patent 11083772 listed to expire 28 February 2034Patent 11083771 listed to expire 28 February 2034Patent 9687519 listed to expire 28 February 2034Exclusivity NCE to 19 September 2030Exclusivity ODE-551 to 19 September 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 September 2030Exclusivity NCE Forzinity
  • 19 September 2032Exclusivity ODE-551 Forzinity
  • 20 January 2027Patent 7576061 drug substance
  • 28 February 2034Patent 12268724
  • 28 February 2034Patent 11771734
  • 28 February 2034Patent 11083772
  • 28 February 2034Patent 11083771
  • 28 February 2034Patent 9687519

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.