NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Drug Patent Profile

When do Naloxone Hydrochloride (autoinjector) patents expire, and when can generic versions of Naloxone Hydrochloride (autoinjector) launch?

Naloxone Hydrochloride (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. There are six patents protecting this drug.

This drug has thirty-five patent family members in ten countries.

The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naloxone Hydrochloride (autoinjector)

A generic version of NALOXONE HYDROCHLORIDE (AUTOINJECTOR) was approved as naloxone hydrochloride by HOSPIRA on September 24^th, 1986.

Summary for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

International Patents:	35
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
DailyMed Link:	NALOXONE HYDROCHLORIDE (AUTOINJECTOR) at DailyMed

Recent Clinical Trials for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

Sponsor	Phase
Purdue Pharma LP	PHASE1
Pfizer	Phase 1
National Institute on Drug Abuse (NIDA)	Phase 1

See all NALOXONE HYDROCHLORIDE (AUTOINJECTOR) clinical trials

Pharmacology for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No			Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No			Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No			Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No			Y

Expired US Patents for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022

International Patents for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

See the table below for patents covering NALOXONE HYDROCHLORIDE (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2440039	Devices, systems and methods for medicament delivery
European Patent Office	2285360	DISPOSITIF DE DISTRIBUTION DE MÉDICAMENT COMPRENANT UN SYSTÈME DE CIRCUIT ÉLECTRONIQUE (MEDICAMENT DELIVERY DEVICE HAVING AN ELECTRONIC CIRCUIT SYSTEM)
Japan	2014504930
Hong Kong	1123758	DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY
United Kingdom	2477483	Apparatus and methods for self-administration of vaccines and other medicaments
Canada	3029371	APPAREILS, SYSTEMES ET METHODES POUR ADMINISTRATION D'UN MEDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY)

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

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

Market Dynamics and Financial Trajectory for NALOXONE HYDROCHLORIDE (Autoinjector)

Last updated: July 29, 2025

Introduction

Naloxone Hydrochloride in autoinjector form stands at the forefront of emergency opioid overdose treatment, driven by escalating global opioid crisis concerns. Its strategic positioning within pharmaceutical and public health domains offers substantial growth potential. This analysis delineates the market dynamics, financial trajectory, and future outlooks for the naloxone autoinjector, emphasizing key drivers, competitive landscape, regulatory influences, and economic implications.

Market Overview

Globally, the naloxone autoinjector segment is experiencing rapid development, largely attributable to rising overdose incidences involving opioids such as heroin and synthetic opioids like fentanyl. The United States, grappling with an opioid epidemic that claimed over 100,000 lives in 2021 (CDC), embodies the primary market for naloxone autoinjectors. As public health policies evolve, demand for user-friendly, reliable overdose reversal devices has surged, positioning the autoinjector as a critical tool over traditional vial-and-syringe formulations.

Market Drivers

1. Rising Opioid Overdose Incidents

The surge in opioid-related deaths directly propels the demand for immediate, accessible overdose treatments. The CDC attributes the spike partly to fentanyl proliferation, prompting emergency services, healthcare providers, and community organizations to stock naloxone autoinjectors.

2. Regulatory Endorsement and Policy Initiatives

Governments worldwide increasingly endorse naloxone access. The U.S. FDA’s approvals of various auto-injector formulations and state-level standing orders facilitate widespread availability, reducing legal barriers for distribution and administration. Such policies amplify market penetration and user accessibility.

3. Ease of Use and Community Distribution

Autoinjectors are designed for layperson use, enabling non-medical personnel to respond effectively in overdose scenarios. This user-friendliness expands their reach within community and first responder settings, crucial during the COVID-19 pandemic where healthcare access is strained.

4. Product Innovation and Diversification

Advancements in device technology, including features like pre-measured doses, tamper-resistance, and portability, enhance adoption. Companies are developing intuitive autoinjector devices that cater to various user demographics, further entrenching their market position.

5. Increasing Public and Private Funding

Many governments and non-profit organizations allocate significant funding toward overdose prevention programs, purchasing naloxone autoinjectors in bulk for distribution. This influx of capital ensures steady market demand and incentivizes manufacturing scale-up.

Market Restraints

1. High Cost and Reimbursement Challenges

Despite its life-saving benefits, the high per-unit cost of naloxone autoinjectors limits affordability for some consumers and public programs. Reimbursement policies vary, affecting adoption rates across different regions and healthcare systems.

2. Patent Expirations and Generic Competition

Patent expirations of key devices may introduce generic alternatives, exerting downward pressure on prices and margins within the market.

3. Legislation Variability

Regulatory heterogeneity across countries complicates global expansion. Restrictions on over-the-counter sale or distribution impede widespread access, especially in low-to-middle-income regions.

4. Stigmatization and Public Awareness

Stigmatization surrounding opioid addiction can hinder acceptance and distribution of naloxone autoinjectors, impacting market growth, particularly in areas with limited education about overdose reversal.

Competition Landscape

The competitive arena is characterized by a handful of key players, including Adapt Pharma (a subsidiary of Alkermes), Mylan (now Viatris), Teva Pharmaceuticals, and Kaleo. Kaleo’s EpiPen-like device, EVZIO, was the first auto-injector approved by the FDA for opioid overdose reversal, setting a precedent for device design and deployment.

Emerging entrants and collaborations aim to diversify product offerings, reduce costs, and streamline distribution channels. The market’s consolidation tendencies suggest potential for mergers and acquisitions, seeking to enhance market share and technological capabilities.

Financial Trajectory

Revenue Growth Trends

The outlook for financial growth in the naloxone autoinjector sector remains optimistic, driven by:

• Forecast CAGR of approximately 9-12% over the next five years (MarketWatch, 2022).
• Increased procurement by public agencies and healthcare providers.
• Expansion into international markets, where opioid crisis awareness is rising.

Pricing Strategies and Profitability

Innovative devices command premium pricing, often ranging from $600 to $900 per autoinjector, justified by technological sophistication and emergency readiness. However, increasing generic competition is expected to moderate prices, pressuring profit margins.

Impact of Public Funding

Government agencies, notably the CDC, purchase significant quantities of naloxone autoinjectors through grants and subsidy programs, stabilizing sales channels. This reliance on public procurement underscores the importance of policy stability for financial forecasts.

Market Penetration and Expansion

Expanding product access in low-income regions and integrating with community health initiatives will influence revenue growth. Strategic collaborations with non-profits, hospitals, and pharmacies are pivotal for scaling.

Cost Dynamics

Manufacturing costs are declining due to technological efficiencies and larger economies of scale, bolstering margins amid price pressures. Nonetheless, expenses linked to regulatory compliance, marketing, and education campaigns remain substantial.

Regulatory and Policy Influences

Regulatory oversight profoundly influences market dynamics. The FDA’s fast-tracking of naloxone auto-injectors facilitates market entry, while legislative actions such as standing orders and over-the-counter (OTC) sales accelerate distribution. Conversely, restrictive policies or lack of regulatory harmonization globally can hamper growth trajectories.

Future Outlook and Opportunities

The trajectory for naloxone autoinjectors hinges on comprehensive efforts addressing opioid addiction and overdose prevention. Opportunities include:

• Broadening global access, especially in regions with burgeoning opioid misuse.
• Innovating device design to lower costs and improve user experience.
• Developing combination products with long-acting formulations or integrated digital health features.
• Expanding training and awareness programs to destigmatize use and embolden community distribution.

Advancements in device technology and policy support will determine the pace of market expansion, with the potential for compounded revenue growth driven by public health imperatives.

Key Takeaways

• The opioid crisis remains the predominant driver of demand for naloxone autoinjectors, with public health policies further incentivizing adoption.
• Technological innovations and community-oriented distribution channels bolster market growth prospects.
• Cost and reimbursement considerations, alongside regulatory variability, pose significant challenges to market expansion.
• The competitive landscape is consolidating, with established players and new entrants vying for market share through innovation and strategic collaborations.
• Financial forecasts indicate sustained growth, contingent upon policy stability, cost reduction, and global expansion efforts.

FAQs

1. What factors most significantly impact the market growth for naloxone autoinjectors?
The primary drivers include rising opioid overdose rates, supportive regulatory policies, ease of use, and expanding community distribution programs. Challenges like high costs and legislation variability also influence growth.

2. How do public policies influence the availability of naloxone autoinjectors?
Policies such as standing orders and OTC approvals facilitate broader access and distribution, directly impacting sales volume and market penetration.

3. What is the role of technological innovation in this market?
Innovations improve device safety, user-friendliness, and affordability, increasing adoption among non-medical users and expanding market reach.

4. How does pricing affect the market dynamics of naloxone autoinjectors?
High prices initially sustain profitability; however, generic competition and price negotiations can lower margins, affecting manufacturers’ growth strategies.

5. What are the future opportunities for growth in this market?
Global expansion, product diversification, integration with digital health, and government-driven overdose prevention initiatives present significant opportunities.

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Sources
[1] Centers for Disease Control and Prevention (CDC). 2022. “Drug Overdose Deaths.”
[2] MarketWatch. 2022. “Opioid Overdose Antidotes Market Report.”