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, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Adapt, Bristol Myers Squibb, Kaleo Inc, Zmi Pharma, Amneal, Padagis Israel, Teva Pharms Usa, Emergent, Amphastar Pharms Inc, Harm Reduction Therp, Summit Biosci, Purdue Pharma Lp, Lupin, Sun Pharm Inds Ltd, and Sanofi Aventis Us, and is included in eighty-nine NDAs. There are forty-eight 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-five patent family members in thirty-eight countries.

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

Summary for NALOXONE HYDROCHLORIDE

International Patents:	245
US Patents:	48
Tradenames:	14
Applicants:	40
NDAs:	89
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	356
Patent Applications:	2,579
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
Murdoch Childrens Research Institute	Phase 4
Johns Hopkins University	Phase 3
Cure Addiction Now	Phase 3

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
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Amphastar Pharms Inc	REXTOVY	naloxone hydrochloride	SPRAY, METERED;NASAL	208969-001	Mar 7, 2023		RX	Yes	Yes
Baxter Hlthcare Corp	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	214785-001	Jan 29, 2021	AP	RX	No	No
Kaleo Inc	EVZIO (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	209862-001	Oct 19, 2016		DISCN	Yes	No			Y
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014		DISCN	Yes	No			Y

Expired US Patents for NALOXONE HYDROCHLORIDE

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	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014
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	2743303
Spain	2577517
Canada	2942611	PRODUITS DE MEDICAMENT NASAL ET LEURS METHODES D'UTILISATION (NASAL DRUG PRODUCTS AND METHODS OF THEIR USE)
Israel	209219	מתקן להעברת התרופה בעל מערכת מעגל אלקטרוני (Medicament delivery device having an electronic circuit system)
Turkey	201802716

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

NALOXONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naloxone Hydrochloride

Introduction

Naloxone hydrochloride, a potent opioid antagonist, has become a critical component in the fight against the opioid epidemic. The market for naloxone is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics, financial trajectory, and the challenges associated with this life-saving drug.

Market Size and Growth

The U.S. naloxone market is projected to grow substantially, valued at USD 550.4 million in 2024 and expected to reach USD 1,086.1 million by 2031, with a compound annual growth rate (CAGR) of 10.2% from 2024 to 2031[1].

Global Market Outlook

On a global scale, the naloxone market is anticipated to reach $2.1 billion by 2030, with a CAGR of 10.8% from 2024 to 2030. This growth is driven by increasing drug dependency, rising public awareness of opioid addiction, and government initiatives for naloxone distribution[4].

Drivers of Market Growth

Several factors are driving the growth of the naloxone market:

Increasing Prevalence of Opioid Abuse

The rising incidence of opioid abuse disorders and overdose deaths is a significant driver. As the opioid crisis deepens, the demand for naloxone as an emergency treatment increases[1].

Government Initiatives

Government initiatives aimed at curbing the opioid crisis, such as public funding programs to make naloxone more affordable and accessible, are boosting market growth. Laws and policies that expand access to naloxone, including standing orders and prescriptive authority laws, also play a crucial role[1][5].

Public Awareness and Education

Growing awareness about overdose emergencies and the availability of various delivery forms of naloxone, such as auto-injectors and nasal sprays, is enhancing adoption rates. The ease of use and safety of intranasal naloxone, in particular, are expected to drive high growth in this segment[4].

Market Segmentation

The naloxone market can be segmented in several ways:

Route of Administration

• Intranasal: Expected to witness the highest growth due to its ease of use and increasing availability.
• Intramuscular/Subcutaneous: Another significant segment, though less convenient than intranasal.
• Intravenous: Primarily used in medical settings[4].

Distribution Channels

• Hospitals: A major distribution channel, especially for emergency treatments.
• Clinics: Increasingly important as more clinics integrate naloxone into their emergency protocols.
• Retail Pharmacies: Key for over-the-counter (OTC) sales and community access.
• Emergency Medical Services: Critical for immediate response to overdoses.
• Military Facilities: Important for addressing opioid issues within military populations[4].

Geographic Regions

• North America: Expected to witness the highest growth due to high rates of overdoses and opioid misuse, as well as progressive policies in states like California and Washington[1][4].

Financial Trajectory

Out-of-Pocket Costs

The financial trajectory of naloxone is complex, particularly when considering out-of-pocket costs. For insured patients, the mean out-of-pocket (OOP) cost of naloxone decreased by 26% from 2014 to 2018. However, for uninsured patients, the OOP cost increased dramatically, by 506% over the same period. This disparity highlights a significant financial barrier to access, especially for certain brands like Evzio, which saw a mean OOP cost of $2,136.37 in 2016 for uninsured patients[2].

Revenue and Sales

The commercial sales of NARCAN® Naloxone HCl Nasal Spray, for example, were $266 million for the 12 months ended February 2024. Additionally, significant volumes of naloxone are acquired directly by U.S. states and municipalities, indicating a robust market demand[3].

Market Challenges

Regulatory Compliance

Regulatory compliance remains a challenge. While laws addressing liability costs have some effect, they do not significantly impact the volume of naloxone dispensed. Policies must also address price barriers to increase access[5].

Cost and Affordability

The high cost of naloxone products, especially for uninsured patients, is a major hindrance. Efforts to make naloxone more affordable through public funding and generic options are crucial for market growth[1][2].

Regional Variations

The Northeast region of the U.S. currently dominates the market due to higher incidence rates of drug overdoses in states like New York and New Jersey. However, the West region is anticipated to offer lucrative opportunities as states like California and Washington implement progressive naloxone access policies[1].

Recent Developments

FDA Approvals

The recent FDA approval of Amneal's OTC Naloxone Hydrochloride Nasal Spray marks a significant milestone in increasing access to naloxone. This approval is expected to further drive market growth by making the drug more readily available to the general public[3].

Key Takeaways

• The naloxone market is expected to grow significantly, driven by increasing opioid abuse, government initiatives, and public awareness.
• The intranasal route of administration is forecasted to witness the highest growth.
• Financial barriers, particularly for uninsured patients, remain a significant challenge.
• Regulatory compliance and cost affordability are critical factors that need to be addressed.
• Recent FDA approvals and public funding initiatives are expected to enhance market growth.

FAQs

What is the projected market size of the U.S. naloxone market by 2031?

The U.S. naloxone market is expected to reach USD 1,086.1 million by 2031[1].

How does the out-of-pocket cost of naloxone vary between insured and uninsured patients?

For insured patients, the mean OOP cost of naloxone decreased by 26% from 2014 to 2018, while for uninsured patients, it increased by 506% over the same period[2].

Which region is expected to witness the highest growth in the naloxone market?

North America is expected to witness the highest growth due to high rates of overdoses and opioid misuse, as well as progressive policies in certain states[1][4].

What are the main drivers of the global naloxone market?

The main drivers include growing dependency on drugs, rising public awareness of opioid addiction, and government initiatives for naloxone distribution[4].

How does the recent FDA approval of OTC naloxone impact the market?

The recent FDA approval of OTC naloxone is expected to increase access and drive market growth by making the drug more readily available to the general public[3].

Sources

1. Coherent Market Insights: "U.S. Naloxone Market Size and Trends"
2. PubMed: "Trends in Out-of-Pocket Costs for Naloxone by Drug Brand and Payer"
3. Amneal Investors: "Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray"
4. GlobeNewswire: "Global Naloxone Market to Reach $2.1 Billion by 2030 with a CAGR of 10.8%"
5. PMC: "Investigating the complexity of naloxone distribution: Which policies are most effective?"