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. Forty-five 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 24^th, 1986.

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Summary for NARCAN

International Patents:	27
US Patents:	2
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	21
Patent Applications:	4,249
Drug Prices:	Drug price information for NARCAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NARCAN
What excipients (inactive ingredients) are in NARCAN?	NARCAN excipients list
DailyMed Link:	NARCAN at DailyMed

Drug patent expirations by year for NARCAN

Recent Clinical Trials for NARCAN

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

Sponsor	Phase
Johns Hopkins University	Phase 3
Cure Addiction Now	Phase 3
Purdue Pharma LP	Phase 4

See all NARCAN clinical trials

Pharmacology for NARCAN

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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.

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y		Y	⤷ Sign Up
Bristol Myers Squibb	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	071083-001	Jul 28, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y		Y	⤷ Sign Up
Adapt	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	016636-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Spain	2631504	MEDICAMENTOS DE ADMINISTRACION NASAL Y METODOS PARA SU USO (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE)	⤷ Sign Up
Mexico	2016011902	MEDICAMENTOS DE ADMINISTRACION NASAL Y METODOS PARA SU USO. (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE.)	⤷ Sign Up
Russian Federation	2016136714	НАЗАЛЬНЫЕ ГОТОВЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2017049181		⤷ Sign Up
Canada	2950687	PRODUITS DE MEDICAMENT ADMINISTRE PAR VOIE NASALE ET METHODES D'UTILISATION ASSOCIEES (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NARCAN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg	⤷ Sign Up	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