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Last Updated: January 18, 2021

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NARCAN Drug Profile

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

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

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

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

Drug patent expirations by year for NARCAN
Drug Prices for NARCAN

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Recent Clinical Trials for NARCAN

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SponsorPhase
Johns Hopkins UniversityPhase 1
University of California, San FranciscoPhase 1
Sameh Hanna, MDEarly Phase 1

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Pharmacology for NARCAN
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Paragraph IV (Patent) Challenges for NARCAN
Tradename Dosage Ingredient NDA Submissiondate
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2017-12-28
NARCAN SPRAY, METERED;NASAL naloxone hydrochloride 208411 2016-07-15

US Patents and Regulatory Information for NARCAN

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   Start Trial   Start Trial   Start Trial
Adapt NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411-002 Jan 24, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb NARCAN naloxone hydrochloride INJECTABLE;INJECTION 071083-001 Jul 28, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Adapt NARCAN naloxone hydrochloride SPRAY, METERED;NASAL 208411-001 Nov 18, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NARCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1685839 92292 Luxembourg   Start 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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Serving leading biopharmaceutical companies globally:

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