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OmniRx › Tools › Generic competition check › Edaravone

Generic competition · all medicines · read 12 November 2026

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

Edaravone appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them. 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. Where both are dated, the first generic approval came 7 years after the first brand approval. 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.
Edaravone2 dosage-form groups in the Orange Book
4generic makers listed
  1. Edaravone appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them.
  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. Where both are dated, the first generic approval came 7 years after the first brand approval.
  4. 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, Intravenous

Four or more generic makers listed

Every brand product here is listed as discontinued. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 6 May 2024.

201520202025203004brand 2017Gland Pharma Ltd, first approval 6 May 2024Hikma Pharmaceuticals Usa Inc, first approval 6 May 2024Sandoz Inc, first approval 23 December 2024Zydus Pharmaceuticals Usa Inc, first approval 22 July 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Gland Pharma Ltd6 May 20241
Hikma Pharmaceuticals Usa Inc6 May 20241
Sandoz Inc23 December 20241
Zydus Pharmaceuticals Usa Inc22 July 20261

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Suspension, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Radicava Ors. No generic is listed as marketed.

20202025203020352040204501brand 2022data datePatent 11478450 listed to expire 1 November 2039Patent 10987341 listed to expire 1 November 2039Patent 12285409 listed to expire 1 November 2039Patent 12599586 listed to expire 1 November 2039Patent 11241416 listed to expire 1 November 2039Patent 11957660 listed to expire 1 November 2039Patent 11826352 listed to expire 1 November 2039Patent 12310946 listed to expire 12 November 2041Patent 12569469 listed to expire 12 November 2041Patent 12527769 listed to expire 12 November 2041Patent 12194025 listed to expire 12 November 2041Patent 12478611 listed to expire 12 November 2041Exclusivity ODE-144 to 12 May 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 12 May 2029Exclusivity ODE-144 Radicava Ors
  • 1 November 2039Patent 11478450
  • 1 November 2039Patent 10987341 drug product
  • 1 November 2039Patent 12285409 drug product
  • 1 November 2039Patent 12599586 drug product
  • 1 November 2039Patent 11241416 drug product
  • 1 November 2039Patent 11957660 drug product
  • 1 November 2039Patent 11826352 drug product
  • 12 November 2041Patent 12310946

4 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.