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OmniRx › Tools › Generic competition check › Naloxone Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Naloxone Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 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 between 3.4 and 4.3 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.
Naloxone Hydrochloride4 dosage-form groups in the Orange Book
19generic makers listed
  1. Naloxone Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 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 between 3.4 and 4.3 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.

Injectable, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 16 generic makers with 30 generic products listed as marketed; the first generic approval is dated 24 September 1986.

19801985199019952000200520102015202020252030016brand 1982Hikma Pharmaceuticals Usa Inc, first approval 24 September 1986Hospira Inc, first approval 24 September 1986International Medication System, first approval 24 March 1988Mylan Institutional Llc, first approval 6 March 2014Rising Pharma Holdings Inc, first approval 28 February 2017Somerset Therapeutics Llc, first approval 26 July 2017Eugia Pharma Specialities Ltd, first approval 4 November 2019Dr Reddys Laboratories Ltd, first approval 16 March 2020Baxter Healthcare Corp, first approval 29 January 2021Mylan Laboratories Ltd, first approval 9 June 2022Ph Health Ltd, first approval 29 July 2022Accord Healthcare Inc, first approval 26 October 2022Bpi Labs Llc, first approval 6 October 2023Mankind Pharma Ltd, first approval 29 February 2024Fresenius Kabi Usa Llc, first approval 2 April 2024Sterinova Inc, first approval 21 August 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc24 September 19863
Hospira Inc24 September 19863
International Medication System24 March 19881
Mylan Institutional Llc6 March 20142
Rising Pharma Holdings Inc28 February 20172
Somerset Therapeutics Llc26 July 20172
Eugia Pharma Specialities Ltd4 November 20192
Dr Reddys Laboratories Ltd16 March 20201
Baxter Healthcare Corp29 January 20213
Mylan Laboratories Ltd9 June 20221
Ph Health Ltd29 July 20221
Accord Healthcare Inc26 October 20222

4 more makers are listed in the data.

Patents and exclusivities still listed

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

Spray, Metered, Nasal

One to three generic makers listed

Brand listed as marketed: Narcan, Rextovy and Rivive. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 19 April 2019.

2015202020252030203503brand 2015Teva Pharmaceuticals Usa Inc, first approval 19 April 2019Padagis Israel Pharmaceuticals Ltd, first approval 21 June 2022Amneal Pharmaceuticals Llc, first approval 23 April 2024data datePatent 12458591 listed to expire 11 May 2032Patent 11020343 listed to expire 11 May 2032Patent 11806428 listed to expire 11 May 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Teva Pharmaceuticals Usa Inc19 April 20191
Padagis Israel Pharmaceuticals Ltd21 June 20221
Amneal Pharmaceuticals Llc23 April 20241

Patents and exclusivities still listed

  • 11 May 2032Patent 12458591
  • 11 May 2032Patent 11020343
  • 11 May 2032Patent 11806428 drug product

Solution, Intramuscular, Subcutaneous

Brand listed, no generic listed as marketed

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

2010201520202025203020352040204501brand 2014data datePatent 11027072 listed to expire 24 May 2039Patent 11571518 listed to expire 14 June 2041
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 24 May 2039Patent 11027072 drug product
  • 14 June 2041Patent 11571518 drug product

Spray, Nasal

Brand listed, no generic listed as marketed

Brand listed as marketed: Kloxxado and Rezenopy. No generic is listed as marketed (1 generic product listed as discontinued).

20202025203020352040204501brand 2021data datePatent 11617713 listed to expire 26 August 2034Patent 11628139 listed to expire 26 August 2034Patent 10973814 listed to expire 26 August 2034Patent 10722510 listed to expire 26 August 2034Patent 11975096 listed to expire 26 August 2034Patent 12414915 listed to expire 26 August 2034Patent 11135155 listed to expire 26 August 2034Patent 12514854 listed to expire 5 February 2041Patent 12622903 listed to expire 5 February 2041Exclusivity NP to 19 April 2027
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 April 2027Exclusivity NP Rezenopy
  • 26 August 2034Patent 11617713 drug product
  • 26 August 2034Patent 11628139 drug product
  • 26 August 2034Patent 10973814 drug product
  • 26 August 2034Patent 10722510 drug product
  • 26 August 2034Patent 11975096 drug product
  • 26 August 2034Patent 12414915 drug product
  • 26 August 2034Patent 11135155 drug product
  • 5 February 2041Patent 12514854

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.