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Generic Narcan Nasal Spray Availability

Last updated on Sep 8, 2022.

Narcan Nasal Spray is a brand name of naloxone, approved by the FDA in the following formulation(s):

NARCAN (naloxone hydrochloride - injectable;injection)

  • Manufacturer: ADAPT
    Approved Prior to Jan 1, 1982
    Strength(s): 0.02MG/ML (discontinued) [RLD], 0.4MG/ML (discontinued) [RLD]
  • Manufacturer: ADAPT
    Approval date: June 14, 1982
    Strength(s): 1MG/ML (discontinued) [RLD]

NARCAN (naloxone hydrochloride - spray, metered;nasal)

  • Manufacturer: EMERGENT
    Approval date: November 18, 2015
    Strength(s): 4MG/SPRAY [RLD] [AB]
  • Manufacturer: EMERGENT
    Approval date: January 24, 2017
    Strength(s): 2MG/SPRAY (discontinued) [RLD]

Has a generic version of Narcan Nasal Spray been approved?

A generic version of Narcan Nasal Spray has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Narcan Nasal Spray and have been approved by the FDA:

naloxone hydrochloride spray, metered;nasal

  • Manufacturer: PADAGIS ISRAEL
    Approval date: June 21, 2022
    Strength(s): 4MG/SPRAY [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: April 19, 2019
    Strength(s): 4MG/SPRAY [AB]

Note: No generic formulation of the following product is available.

  • naloxone hydrochloride - injectable;injection

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Narcan Nasal Spray. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Nasal drug products and methods of their use
    Patent 10,085,937
    Issued: October 2, 2018
    Assignee(s): ADAPT PHARMA LIMITED OPIANT PHARMACEUTICALS

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
  • Nasal drug products and methods of their use
    Patent 9,211,253
    Issued: December 15, 2015
    Assignee(s): Lightlake Therapeutics Inc.

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,468,747
    Issued: October 18, 2016
    Assignee(s): Opiant Pharmaceuticals, Inc.

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,480,644
    Issued: November 1, 2016
    Assignee(s): Opiant Pharmaceuticals, Inc.

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,561,177
    Issued: February 7, 2017
    Assignee(s): ADAPT PHARMA LIMITED OPIANT PHARMACEUTICALS

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,629,965
    Issued: April 25, 2017
    Assignee(s): Opiant Pharmaceuticals, Inc.

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,707,226
    Issued: July 18, 2017
    Assignee(s): ADAPT PHARMA LIMITED OPIANT PHARMACEUTICALS

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
      ✓ 
      Drug product
  • Nasal drug products and methods of their use
    Patent 9,775,838
    Issued: October 3, 2017
    Assignee(s): ADAPT PHARMA LIMITED OPIANT PHARMACEUTICALS

    Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.

    Patent expiration dates:

    • March 16, 2035
      ✓ 
      Patent use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.