NALOXONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for naloxone hydrochloride and what is the scope of patent protection?

Naloxone hydrochloride is the generic ingredient in fourteen branded drugs marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Ph Health, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Sterinova Inc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Zmi Pharma, Amneal, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Scienture, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in ninety-one NDAs. There are forty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride has two hundred and forty-seven patent family members in thirty-nine countries.

There are eight drug master file entries for naloxone hydrochloride. Forty-eight suppliers are listed for this compound.

Summary for NALOXONE HYDROCHLORIDE

International Patents:	247
US Patents:	41
Tradenames:	14
Applicants:	40
NDAs:	91
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	379
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE
What excipients (inactive ingredients) are in NALOXONE HYDROCHLORIDE?	NALOXONE HYDROCHLORIDE excipients list
DailyMed Link:	NALOXONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NALOXONE HYDROCHLORIDE

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

Sponsor	Phase
University of California, San Francisco	PHASE2
University of North Carolina, Chapel Hill	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4

See all NALOXONE HYDROCHLORIDE clinical trials

Pharmacology for NALOXONE HYDROCHLORIDE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Medical Subject Heading (MeSH) Categories for NALOXONE HYDROCHLORIDE

Narcotic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALOXONE HYDROCHLORIDE

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KLOXXADO	Nasal Spray	naloxone hydrochloride	8 mg/spray	212045	1	2023-03-30
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 NALOXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072083-001	Apr 11, 1989		DISCN	No	No
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072088-001	Apr 11, 1989		DISCN	No	No
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Hikma	KLOXXADO	naloxone hydrochloride	SPRAY;NASAL	212045-001	Apr 29, 2021		RX	Yes	Yes			Y
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072089-001	Apr 11, 1989		DISCN	No	No

Expired US Patents for NALOXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016

International Patents for NALOXONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2762072
United Kingdom	2538682	Nasal drug products and methods of their use
Canada	2926365
New Zealand	617442
World Intellectual Property Organization (WIPO)	2006057636

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE

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

Last updated: July 28, 2025

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Introduction

Naloxone hydrochloride, a potent opioid antagonist, has become a critical tool in combating opioid overdose deaths worldwide. Its emergency-use viability, combined with increasing opioid crisis awareness, has significantly influenced market growth, regulatory pathways, and investment patterns. This article explores the evolving market landscape and financial prospects for naloxone hydrochloride, emphasizing key drivers, barriers, and future opportunities.

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Current Market Landscape

Global Market Size and Growth Trends

The global naloxone market was valued at approximately USD 800 million in 2022 and is projected to reach over USD 1.8 billion by 2030, registering a compound annual growth rate (CAGR) of approximately 10.3% (2023–2030) [1]. This surge stems from escalating opioid overdose fatalities, increasing adoption of naloxone in community and clinical settings, and expanding healthcare policies supporting overdose prevention.

Key Players and Supply Chain Dynamics

Major pharmaceutical companies such as Amphastar Pharmaceuticals, Mylan (now part of Viatris), and Teva Pharmaceuticals dominate the current market, primarily through the production of intranasal and injectable formulations. The supply chain involves raw material suppliers, manufacturing units, regulatory agencies, wholesalers, and healthcare providers, with recent shifts focusing on scalable production to meet surging demand.

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Market Drivers

Rising Opioid Overdose Incidents

The opioid epidemic remains the primary catalyst. According to CDC data, over 101,000 overdose deaths occurred in the US in 2021, with opioids involved in approximately 75% of cases [2]. This alarming trend amplifies the demand for accessible naloxone formulations.

Regulatory Support and Policy Initiatives

Governments and health authorities worldwide have introduced favorable policies, including standing orders, over-the-counter (OTC) availability, and funding for distribution programs. In the US, the FDA approved non-prescription (OTC) sales of nasal naloxone in 2023, expanding accessibility [3].

Evolving Formulations and Delivery Systems

Innovation in naloxone delivery methods—such as auto-injectors, nasal sprays, and multi-dose kits—improves ease of use, encouraging layperson administration. Market introductions, like the Narcan nasal spray, have widened consumer acceptance.

Increased Awareness and Public Health Campaigns

Public health initiatives and community-based training foster greater awareness, promoting naloxone stocking among first responders, community organizations, and individuals at risk.

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Market Barriers and Challenges

Regulatory and Patent Barriers

While some formulations enjoy patent protections, expirations and the emergence of generic products pressure pricing and margins. Additionally, regulatory hurdles in developing countries can limit product registration and commercialization.

Pricing and Reimbursement Issues

Pricing disparities across regions and inadequate reimbursement frameworks constrain broad access, particularly in low- and middle-income countries.

Stigma and Education

Stigma surrounding opioid use hampers distribution and utilization, necessitating ongoing educational campaigns to enhance acceptance.

Manufacturing and Supply Chain Constraints

Global supply chain disruptions, such as those experienced during COVID-19, impact raw material availability, affecting production volumes and costs.

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Financial Trajectory and Investment Insights

Revenue Streams and Market Segments

Revenues stem from proprietary formulations and generics, with the nasal route accounting for nearly 65% of sales globally as of 2022, driven by ease of administration and safety profile [1]. Hospital, emergency services, and community programs constitute the primary markets.

Emerging Markets and Expansion Opportunities

Growing acceptance in Europe, Asia-Pacific, and Latin America presents vast opportunities. India and China are witnessing increasing government investments in overdose prevention, aligning with global health goals.

Innovative Product Development

Biotech firms are exploring longer-acting formulations and depot injections for sustained release, which could command premium pricing and foster new revenue streams.

Investment and Commercial Outlook

Vaccine-like models for OTC naloxone are gaining traction, encouraging investment in marketing and education. Companies with strong R&D pipelines and regulatory expertise are positioned for accelerated growth, driven by high unmet needs and societal imperatives.

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Regulatory and Policy Outlook

Regulatory Pathways

The FDA’s recent OTC approval paves a smoother regulatory pathway in the US, with similar efforts underway internationally. Countries are increasingly adopting standing orders and allowing pharmacy-level distribution, facilitating rapid market expansion [3].

Reimbursements and Public Funding

Public health funding, grant programs, and insurance coverage influence pricing and accessibility, directly impacting sales trajectories and profitability.

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Future Opportunities and Strategic Recommendations

• Product Diversification: Developing auto-injectors with user-friendly designs enhances adoption among laypeople, expanding market reach.
• Global Expansion: Partnering with local distributors and governments can facilitate access in underserved regions.
• Educational Campaigns: Investing in awareness can reduce stigma and improve overdose response rates.
• Regulatory Engagement: Proactive engagement with authorities accelerates approvals and policy adaptations.
• Research & Development: Innovations in delivery methods and formulations can command premium pricing and create barriers for generic entrants.

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Key Market Outlooks

Aspect	Outlook
Market CAGR (2023–2030)	~10.3%
Dominant Delivery System	Nasal sprays (e.g., Narcan)
Major Revenue Contributors	Emergency departments, community programs
Regulatory Environment	Favorable, with increasing OTC approvals
Market Penetration	Expanding in Asia-Pacific, Europe, Latin America

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Key Takeaways

• The opioid crisis remains the primary driver, with escalating overdose deaths prompting heightened demand.
• Regulatory approvals, especially OTC status in key markets like the US, are pivotal for market expansion.
• Innovations in delivery systems and formulations offer growth opportunities and competitive advantages.
• Price and reimbursement policies significantly influence market accessibility, especially in emerging economies.
• Strategic partnerships, educational initiatives, and R&D investments are critical for sustainable growth.

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FAQs

1. What is the current global market size for naloxone hydrochloride?
The global market was valued at around USD 800 million in 2022 and is projected to reach over USD 1.8 billion by 2030, driven by rising overdose incidents and expanded availability [1].

2. How have recent regulatory changes impacted the naloxone market?
The FDA approved OTC nasal naloxone in 2023, significantly increasing accessibility and sales. Similar policies are emerging internationally, supporting broader distribution efforts [3].

3. What are the main formulations available for naloxone administration?
The most common formulations include nasal sprays (e.g., Narcan), injectable solutions, and auto-injectors, with nasal sprays dominating due to ease of administration.

4. What challenges could hinder market growth?
Pricing and reimbursement disparities, regulatory hurdles, stigma, and supply chain disruptions pose challenges to widespread adoption and market expansion.

5. What future innovations are expected in the naloxone market?
Longer-acting formulations, depot injections, and user-friendly auto-injectors are under development, promising to enhance convenience, compliance, and market penetration.

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References

[1] Market Research Future. "Naloxone Hydrochloride Market Analysis." 2023.

[2] CDC. "2021 Overdose Death Rates." Centers for Disease Control and Prevention.

[3] FDA. "Approval of Non-Prescription Naloxone." 2023.

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This comprehensive analysis provides a strategic overview of the market dynamics and financial prospects surrounding naloxone hydrochloride, serving as a guide for stakeholders seeking informed investment and operational decisions.