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Last Updated: April 13, 2024

NARCAN Drug Patent Profile


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When do Narcan patents expire, and what generic alternatives are available?

Narcan is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent. and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in NARCAN is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Narcan

A generic version of NARCAN was approved as naloxone hydrochloride by HOSPIRA on September 24th, 1986.

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Drug patent expirations by year for NARCAN
Drug Prices for NARCAN

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Recent Clinical Trials for NARCAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Purdue Pharma LPPhase 4
University of Alabama at BirminghamPhase 4
Rush University Medical CenterEarly Phase 1

See all NARCAN clinical trials

Pharmacology for NARCAN
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Paragraph IV (Patent) Challenges for NARCAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NARCAN Nasal Spray naloxone hydrochloride 2 mg/spray 208411 1 2017-12-28
NARCAN Nasal Spray naloxone hydrochloride 4 mg/spray 208411 1 2016-07-15

US Patents and Regulatory Information for NARCAN

NARCAN is protected by two US patents.

Patents protecting NARCAN

Nasal drug products and methods of their use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented 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 Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Adapt NARCAN naloxone hydrochloride INJECTABLE;INJECTION 016636-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emergent NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411-002 Jan 24, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bristol Myers Squibb NARCAN naloxone hydrochloride INJECTABLE;INJECTION 071083-001 Jul 28, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emergent NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411-002 Jan 24, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for NARCAN

See the table below for patents covering NARCAN around the world.

Country Patent Number Title Estimated Expiration
Israel 279001 תרופות לאף ושיטות שימוש בהן (Nasal drug products and methods of their use) ⤷  Try a Trial
Mexico 2018003349 PRODUCTOS DE FARMACO NASAL Y METODOS DE SU USO. (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE.) ⤷  Try a Trial
Hong Kong 1231370 鼻用藥物產品及其使用方法 (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE) ⤷  Try a Trial
Germany 112015001251 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NARCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.