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NARCAN

NDA

NALOXONE HYDROCHLORIDE | N208411 | EMERGENT OPERATIONS IRELAND LTD

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ADAPT PHARMA OPERATIONS LIMITED et al v. PERRIGO UK FINCO LIMITED PARTNERSHIP 2:2018cv16987 1 patentANDA 211951naloxone hydrochloride	D.N.J.	2018-12-07	Terminated 2019-05-03	—
ADAPT PHARMA OPERATIONS LIMITED et al v. TEVA PHARMACEUTICALS USA, INC. et al 2:2018cv09880	D.N.J.	2018-05-30	Terminated 2018-10-11	—
ADAPT PHARMA OPERATIONS LIMITED et al v. TEVA PHARMACEUTICALS USA, INC. et al 2:2018cv05752 2 patentsANDA 211561naloxone hydrochloride	D.N.J.	2018-04-09	Terminated 2022-07-27	—
ADAPT PHARMA OPERATIONS LIMITED et al v. TEVA PHARMACEUTICALS USA, INC. et al 2:2017cv05100	D.N.J.	2017-07-12	Terminated 2017-09-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0514 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Naloxone HCl Nasal Spray, 8 mg/Spray, suitable for submission as an ANDA, with NARCAN Nasal Spray (NDA 208411) as the reference listed dru	Suitability	2021-05-27	Open	Hyman, Phelps & McNamara, P.C.
Aerscher LLC - Citizen Petition FDA-2009-P-0459 · 4 docket documents Aerscher LLC filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to submit an ANDA for buprenorphine hydrochloride 8mg combined with naloxone hydrochloride 2mg in an orally soluble strip format marketed as Buprox, which differs fr	Other	2009-10-22	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

174 trials from ClinicalTrials.gov — 1 recruiting, 131 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder NCT04375033	Phase 4	Recruiting	VA Office of Research and Development	952	2020-11-03 → 2029-05-31
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function NCT01367561	Phase 1	Completed	Bausch Health Americas, Inc.	15	2002-10 → 2003-05
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients NCT00879996	Phase 4	Completed	State University of New York at Buffalo	54	2009-04 → 2011-10
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.NCT01596764	Phase 1	Completed	University Medicine Greifswald	16	2011-05 → 2012-01
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray NCT03223896	Phase 2	Completed	Finnish Institute for Health and Welfare	20	2017-02-14 → 2017-06-30
Effect of High-dose Naloxone Following Third Molar Extraction NCT02976337	Phase 2	Completed	mads u werner	23	2017-10-12 → 2023-12-27
A Pilot Study of the Bioavailability of Nasal Naloxone NCT01939444	Phase 2	Completed	Norwegian University of Science and Technology	5	2013-08 → 2014-11
PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain NCT01719757	Phase 4	Completed	Mundipharma Korea Ltd	359	2012-07 → 2014-04
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder NCT02669901	N/A	Completed	University of New Mexico	395	2016-04-04 → 2020-08-20
A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain NCT00513656	Phase 2	Completed	Mundipharma Research GmbH & Co KG	230	2007-09 → 2010-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$17.31

per ea

Lowest NADAC/Unit

$17.31

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69547062702NARCAN 4 MG NASAL SPRAY	$17.31	EA	Brand	$15.46	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$33.17

Highest Price

$33.17

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
69547-0627-02NARCAN NASAL SPRAY 4MG	$33.17	FSS	Emergent Devices, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain9 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVNALOXONE HYDROCHLORIDE

DMF 140341999

MACFARLAN SMITH LTDNALOXONE HYDROCHLORIDE

DMF 207452007

FRANCOPIA A EUROAPI CONALOXONE HYDROCHLORIDE

DMF 231422009

SUN PHARMACEUTICAL INDUSTRIES LTDNALOXONE HYDROCHLORIDE DIHYDRATE USP

DMF 233892010

NORAMCO LLCNALOXONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 246332011

SIEGFRIED LTDNALOXONE HYDROCHLORIDE DIHYDRATE

DMF 246682011

SUN PHARMACEUTICAL INDUSTRIES LTDNALOXONE HYDROCHLORIDE DIHYDRATE USP (PROCESS II)

DMF 364322021

SICHUAN QINGMU PHARMACEUTICAL CO LTDNALOXONE

DMF 422332025

NORAMCO LLCNALOXONE HYDROCHLORIDE (PROCESS II)

DMF 430512026

DIOSYNTH BVInactiveNALOXONE HYDROCHLORIDE

DMF 45951982

EXTAL PTY LTD DIV JOHNSON AND JOHNSONInactiveNALOXONE HYDROCHLORIDE

DMF 71381987

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 12, 2026	SUPPL -11	View Letter (PDF)
Jan 16, 2026	SUPPL -10	View Letter (PDF)
Nov 24, 2025	SUPPL -9	View Letter (PDF)
Mar 29, 2023	SUPPL -6	View Letter (PDF)
Mar 28, 2023	SUPPL -7	View Letter (PDF)
Sep 16, 2020	SUPPL -4	View Letter (PDF)
Jan 27, 2017	SUPPL -1	View Letter (PDF)
Nov 19, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4MG/SPRAY

RLD

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Nov 18, 2015

No patent or exclusivity listings for this strength.

#002 — 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SPRAY, METERED;NASAL | Approved: Jan 24, 2017