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NARCAN

NDA

NALOXONE HYDROCHLORIDE | N016636 | ADAPT PHARMA OPERATIONS LTD

3 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - Narcan re Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0514 Hyman, Phelps & McNamara P.C. filed a citizen petition regarding Narcan requesting that the FDA determine the suitability of the drug product for over-the-counter use, which involves evaluating whether the product can be safely and effectively used by consumers without professional supervision.	Suitability	2021-05-27	Open	Hyman, Phelps & McNamara P.C.
Attachment 2 - NARCAN PI re Suitability Petition from Hyman, Phelps & McNamar... FDA-2021-P-0514 The law firm Hyman, Phelps & McNamara P.C. filed a petition regarding NARCAN (naloxone) and its prescribing information suitability. The petition seeks FDA action on matters related to NARCAN's product information and labeling, though the specific requested regulatory action is not detailed in this	Suitability	2021-05-27	Open	Hyman, Phelps & McNamara P.C.
Citizen Petition from BPI Labs, LLC FDA-2021-P-0477 BPI Labs, LLC submitted this citizen petition on May 19, 2021 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA determination that its proposed Naloxone Hydrochloride Injection 2 mg/2 mL (1 mg/mL) formulation is suitable for submission as an Abbreviated New	Other	2021-05-21	Open	BPI Labs, LLC
Aerscher LLC - Citizen Petition FDA-2009-P-0459 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with naloxone hydrochloride 2mg in an orally soluble strip format marketed as Buprox, which differs fr	Other	2009-10-22	Withdrawn	—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

167 trials from ClinicalTrials.gov — 6 recruiting, 3 active, 118 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk NCT07022717	N/A	Active	Boston Medical Center	22	2025-08-25 → 2026-11
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)NCT05886712	N/A	Active	RTI International	31	2023-07-01 → 2027-06-30
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl NCT06089707	Phase 3	Active	University of Maryland, Baltimore	3	2024-01-09 → 2030-01-01
Naloxone for In-Hospital Cardiac Arrest NCT07806565	Phase 2/3	Not Yet Recruiting	Region Skane	850	2027-01-01 → 2031-07-01
Sedation and Guided Education for Depression Study NCT06705270	N/A	Not Yet Recruiting	Stanford University	40	2026-09 → 2028-10
Naloxone for Opioid Associated Out of Hospital Cardiac Arrest NCT06251609	Phase 2	Not Yet Recruiting	University of California, San Francisco	98	2027-03 → 2029-02-28
Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments NCT04893525	Phase 2/3	Recruiting	University of British Columbia	658	2021-07-23 → 2028-06
Low-dose Buprenorphine Initiation for Opioid Use Disorder NCT05450718	Phase 4	Recruiting	Montefiore Medical Center	70	2024-11-11 → 2027-06-30
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
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults NCT05377255	Phase 1	Completed	Emergent BioSolutions	24	2022-03-28 → 2022-05-10

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

Medicare Part D Spending

CMS annual spending data for Narcan (2024)

Total Spending

$1.1M

Total Claims

9,543

Beneficiaries

8,436

Avg Cost/Unit

$55.07

Spending Trend

$51.3M(2019)→$53.4M(2020)→$63.7M(2021)→$12.3M(2022)→$2.2M(2023)→$1.1M(2024)

YoY Change:-13.6%

5yr CAGR:-4.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain8 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

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

2 letters from Drugs@FDA

Date	Submission	Document
Feb 11, 2002	SUPPL -52	View Letter (PDF)
Feb 11, 2002	SUPPL -54	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#003 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 14, 1982