naloxone hydrochloride (autoinjector) Drug Patent Profile

Which patents cover Naloxone Hydrochloride (autoinjector), and what generic alternatives are available?

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

This drug has one hundred and forty-one patent family members in fifteen countries.

The generic ingredient in NALOXONE HYDROCHLORIDE (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-five 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:	141
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
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
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 eighteen 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	10,322,239
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	10,314,977		Y
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	11,590,286		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	8,608,698
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	10,314,977
Kaleo Inc	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022	8,425,462

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
European Patent Office	1998751	APPAREILS, SYSTÈMES ET MÉTHODES POUR ADMINISTRATION D'UN MÉDICAMENT (DEVICES, SYSTEMS AND METHODS FOR MEDICAMENT DELIVERY)
European Patent Office	2680899
Canada	2791286

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

Naloxone hydrochloride (autoinjector) Market Analysis and Financial Projection Experimental

The Naloxone Market: Dynamics, Financial Trajectory, and Future Outlook

Market Overview

The naloxone market is poised for significant growth, driven by the escalating opioid crisis globally. Here are the key dynamics and financial trajectories shaping this market.

Market Size and Growth Projections

The global naloxone market is estimated to be valued at USD 1,341.5 million in 2024 and is projected to reach USD 2,683.9 million by 2031, growing at a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031[1][4].

Drivers of Market Growth

Increasing Prevalence of Opioid Overdose

The rising cases of opioid overdose due to increased opioid prescriptions for chronic pain management are a primary driver of the naloxone market. As opioid misuse continues to surge, the demand for naloxone as an antidote to reverse opioid overdose is expected to increase significantly[1][3].

Favorable Government Policies

Government initiatives aimed at increasing public awareness and availability of naloxone are crucial for market growth. Several states and municipalities now recommend or require naloxone to be co-prescribed with opioid prescriptions, driving up demand[1].

Reimbursement Scenarios

Favorable reimbursement scenarios play a major role in the adoption of naloxone products, especially in developed regions like North America and Europe. Many healthcare plans, including Medicaid, provide coverage for naloxone, making it more accessible and affordable[4].

Route of Administration

Injectable Naloxone

The injectable segment dominates the naloxone market, projected to hold 67.8% of the market share in 2024. Injectable naloxone is preferred due to its higher bioavailability and quicker onset of action, which is critical in emergency situations. It allows for almost instant drug release into the bloodstream, typically reversing an overdose within 2 to 8 minutes[1].

Intranasal and Auto-Injector Formulations

While injectable naloxone is dominant, intranasal and auto-injector formulations are also gaining traction. These formulations, such as Narcan nasal spray, offer ease of use and are particularly beneficial in community settings where immediate medical assistance may not be available[1][3].

Distribution Channels

Retail Pharmacy Dominance

Retail pharmacies are the primary distribution channels for naloxone, driven by accessibility and familiarity. The ease of purchasing naloxone from retail pharmacies, combined with educational programs promoting off-label use, has boosted market growth[1].

Regional Analysis

North America

North America represents the largest market for naloxone, expected to hold 43.8% of the market share in 2024. The region is grappling with a severe opioid epidemic, leading to increased government focus and policy changes to expand access to naloxone[1].

Europe

Europe is the second major region, with countries like Germany, France, and the U.K. showing significant growth. While the opioid crisis is less severe in Europe compared to North America, many European countries are recognizing the therapeutic potential of naloxone and implementing supportive regulatory environments and nationwide healthcare coverage[1].

Financial Barriers and Out-of-Pocket Costs

Impact on Uninsured Patients

The out-of-pocket (OOP) costs for naloxone have become a substantial barrier for uninsured patients. Between 2014 and 2018, the mean OOP cost of naloxone decreased by 26% for insured patients but increased by 606% for uninsured patients. This disparity is particularly pronounced for certain brands like Evzio, where the mean OOP cost rose dramatically for uninsured individuals[2].

Variation by Payer and Drug Brand

The OOP costs vary significantly by payer and drug brand. For instance, the mean OOP cost for Evzio among uninsured patients was significantly higher compared to generic naloxone and Narcan. This highlights the need for policies addressing financial barriers to naloxone access[2].

Research and Development

Clinical Trials and Product Launches

Market players are actively involved in research and development activities. For example, Pfizer completed a Phase 1 clinical trial for a 5 mg intramuscular auto-injector, and Sandoz launched a generic Narcan nasal spray in the U.S. These initiatives are expected to drive market growth through innovative products and formulations[4].

Competitive Landscape

Key Players

The naloxone market is competitive, with key players including Pfizer, West Ward Pharmaceuticals, Amneal Pharmaceuticals, Sandoz, ADAPT Pharma, Mylan, Kaleo, and Amphastar Pharmaceuticals. These companies are engaged in product launches, online platform initiatives, and educational programs to promote naloxone use[3][4].

Online Platforms and Discounts

Increasing Accessibility

Companies like ADAPT Pharma have launched online platforms, such as NARCANDirect.com, to increase accessibility and offer discounts on naloxone products. These initiatives aim to make naloxone more affordable and widely available[4].

Pharmacokinetic Properties

Intranasal vs. Injectable

The pharmacokinetic properties of naloxone formulations vary. Injectable naloxone offers higher bioavailability and a quicker onset of action compared to intranasal formulations. This makes injectable naloxone particularly effective in emergency situations[5].

Key Takeaways

• The naloxone market is expected to grow significantly due to the increasing prevalence of opioid overdose cases.
• Injectable naloxone dominates the market due to its effectiveness and quick onset of action.
• Favorable government policies and reimbursement scenarios are crucial for market growth.
• Financial barriers, particularly for uninsured patients, need to be addressed to improve access to naloxone.
• Research and development activities by market players are driving innovation and growth.

FAQs

What is the projected market size of the naloxone market by 2031?

The global naloxone market is expected to reach USD 2,683.9 million by 2031[1].

Why is the demand for naloxone increasing?

The demand for naloxone is increasing due to the rising cases of opioid overdose and favorable government policies aimed at increasing public awareness and availability of naloxone[1].

Which region dominates the naloxone market?

North America represents the largest market for naloxone, expected to hold 43.8% of the market share in 2024[1].

What is the impact of out-of-pocket costs on naloxone access?

Out-of-pocket costs have become a significant barrier for uninsured patients, with costs increasing by 606% between 2014 and 2018 for certain brands like Evzio[2].

Which companies are key players in the naloxone market?

Key players include Pfizer, West Ward Pharmaceuticals, Amneal Pharmaceuticals, Sandoz, ADAPT Pharma, Mylan, Kaleo, and Amphastar Pharmaceuticals[3][4].

Sources

1. Coherent Market Insights, "Naloxone Market Size & Share Analysis - Industry Research Report".
2. JAMA Health Forum, "Out-of-Pocket Costs for Naloxone by Drug Brand and Payer in the United States".
3. GlobeNewswire, "Naloxone Market Size & Share to Surpass $ 743.25 Million by 2028".
4. GlobeNewswire, "Global Naloxone Market to surpass US$ 2,460.2 Million by 2030".
5. Taylor & Francis Online, "Pharmacokinetic Properties of Intranasal and Injectable Naloxone for Emergency Treatment of Opioid Overdose".