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OmniRx › Tools › Generic competition check › Nalmefene Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Nalmefene Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them. 2 groups have 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 26.8 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.
Nalmefene Hydrochloride3 dosage-form groups in the Orange Book
2generic makers listed
  1. Nalmefene Hydrochloride appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 2 generic makers listed as marketed across them.
  2. 2 groups have 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 26.8 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, Intramuscular, Intravenous, Subcutaneous

One to three generic makers listed

Every brand product here is listed as discontinued. 2 generic makers with 3 generic products listed as marketed; the first generic approval is dated 8 February 2022.

1995200020052010201520202025203002brand 1995Knoa Pharma Llc, first approval 8 February 2022Chengdu Shuode Pharmaceutical Co Ltd, first approval 15 November 2023data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Knoa Pharma Llc8 February 20221
Chengdu Shuode Pharmaceutical Co Ltd15 November 20232

Patents and exclusivities still listed

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

Solution, Intramuscular, Subcutaneous

Brand listed, no generic listed as marketed

Brand listed as marketed: Zurnai (Autoinjector). No generic is listed as marketed.

2020202520302035204001brand 2024data datePatent 11865112 listed to expire 5 November 2039Patent 11857547 listed to expire 5 November 2039Exclusivity NP to 7 August 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 7 August 2027Exclusivity NP Zurnai (Autoinjector)
  • 5 November 2039Patent 11865112 drug product
  • 5 November 2039Patent 11857547 drug product

Spray, Nasal

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2023data datePatent 11458091 listed to expire 10 July 2038Patent 12290596 listed to expire 4 August 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 10 July 2038Patent 11458091 drug product
  • 4 August 2042Patent 12290596

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.