NARCAN Drug Patent Profile

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-four 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.

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

See drug prices for NARCAN

Recent Clinical Trials for NARCAN

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

Sponsor	Phase
Cure Addiction Now	Phase 3
Johns Hopkins University	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

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
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No			Y		Y
Bristol Myers Squibb	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	071083-001	Jul 28, 1988		DISCN	No	No
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No			Y		Y
Adapt	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	016636-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Adapt	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	016636-003	Jun 14, 1982		DISCN	Yes	No
Bristol Myers Squibb	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	071311-001	Jul 28, 1988		DISCN	No	No

International Patents for NARCAN

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3116478	PRODUITS DE MÉDICAMENT NASAL ET LEURS MÉTHODES D'UTILISATION (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE)
Germany	112015001251
China	110755372	适于经鼻递送药物产品、用于鼻内给予的药用组合物及其用途 (Nasal drug products and methods of their use)
Israel	279001	תרופות לאף ושיטות שימוש בהן (Nasal drug products and methods of their use)
Canada	2942611	PRODUITS DE MEDICAMENT NASAL ET LEURS METHODES D'UTILISATION (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE)
Mexico	2016011902	MEDICAMENTOS DE ADMINISTRACION NASAL Y METODOS PARA SU USO. (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE.)
World Intellectual Property Organization (WIPO)	2015136373

Supplementary Protection Certificates for NARCAN

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