NALOXONE HYDROCHLORIDE Drug Patent Profile

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

Naloxone Hydrochloride is a drug marketed by Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, 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, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd. and is included in sixty-eight NDAs. There are eighteen patents protecting this drug.

The generic ingredient in NALOXONE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naloxone Hydrochloride

A generic version of NALOXONE HYDROCHLORIDE was approved as naloxone hydrochloride; pentazocine hydrochloride by WATSON LABS on January 21^st, 1997.

Summary for NALOXONE HYDROCHLORIDE

US Patents:	0
Applicants:	30
NDAs:	68
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	356
Patent Applications:	1,772
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
Cure Addiction Now	Phase 3
Johns Hopkins University	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	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	215457-001	Feb 28, 2022		DISCN	Yes	No	10,335,549		Y
Igi Labs Inc	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	072090-001	Apr 11, 1989		DISCN	No	No
Hospira	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	070257-001	Jan 7, 1987	AP	RX	No	Yes
Lupin	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075735-001	Jul 11, 2001	AB	RX	No	No
Mankind Pharma	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	218404-001	Feb 29, 2024	AP	RX	No	No

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?"