NALTREXONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for naltrexone hydrochloride and what is the scope of freedom to operate?

Naltrexone hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for naltrexone hydrochloride. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NALTREXONE HYDROCHLORIDE

US Patents:	2
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	475
Patent Applications:	2,074
What excipients (inactive ingredients) are in NALTREXONE HYDROCHLORIDE?	NALTREXONE HYDROCHLORIDE excipients list
DailyMed Link:	NALTREXONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NALTREXONE HYDROCHLORIDE

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 1
University of Utah	Phase 1
National Institute of Mental Health (NIMH)	Phase 2

See all NALTREXONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NALTREXONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		8MG/90MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NALTREXONE HYDROCHLORIDE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE HYDROCHLORIDE

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for NALTREXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No			Y
Elite Labs	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075274-001	May 26, 1999	AB	RX	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No			Y
Fosun Pharma	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075434-001	Mar 8, 2000		DISCN	No	No

NALTREXONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naltrexone Hydrochloride

Market Overview

Naltrexone hydrochloride, an opioid antagonist, has been a crucial component in the treatment of alcohol and opioid dependence. The market for this drug is experiencing significant growth, driven by several key factors.

Market Size and Projections

The naltrexone hydrochloride market was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.59 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7% from 2024 to 2031[1].

Key Drivers

Increasing Prevalence of Substance Use Disorders

The rising incidence of alcohol and opioid dependence is a major driver of the naltrexone hydrochloride market. The increasing number of cases of substance use disorders, particularly opioid use disorder (OUD), is propelling the demand for effective treatment options[4].

Government Initiatives and Funding

Government support through financing and legislative efforts is significantly boosting the market. Increased public awareness and funding for addiction treatment programs are key factors driving the growth of the naltrexone hydrochloride market[1].

Advances in Pharmaceutical Formulations

Improvements in medication composition, such as extended-release and injectable formulations, are enhancing treatment outcomes and patient adherence. These advancements are contributing to the market's expansion[2].

Growing Healthcare Infrastructure

The increasing healthcare infrastructure in developing countries is also supporting the growth of the naltrexone hydrochloride market. This infrastructure expansion allows for better access to treatment options, including naltrexone hydrochloride[1].

Market Segmentation

By Type

The market is segmented into naltrexone hydrochloride oral, injectable, and implant forms. Each form has its own set of advantages and is tailored to different patient needs. For instance, injectable and implantable forms offer sustained release, which can improve compliance and efficacy compared to oral forms[1][2].

By Application

Naltrexone hydrochloride is used for various applications, including alcohol dependence treatment, opioid dependence treatment, opioid overdose reversal, and other uses. The opioid dependence treatment segment is particularly significant due to the high prevalence of OUD[1].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America holds a substantial share of the market, driven by high awareness among healthcare professionals and favorable reimbursement policies[4].

Financial Trajectory

Revenue Forecast

The revenue forecast for the naltrexone hydrochloride market indicates a steady increase over the forecast period. The market is expected to grow from USD 1.5 billion in 2023 to USD 2.59 billion by 2031, reflecting a CAGR of 7%[1].

Key Players

Major players in the naltrexone hydrochloride market include Alkermes, Mallinckrodt Pharmaceuticals, Accord Healthcare, Sandoz, and Teva Pharmaceutical Industries. These companies are driving innovation and accessibility in addiction care solutions through various strategies, including regulatory approvals and clinical trials[1].

Challenges and Restraints

Side Effects

Potential side effects from naltrexone hydrochloride treatment, such as nausea, dizziness, and abdominal cramps, are expected to restrain market growth. These side effects can impact patient compliance and overall market adoption[3].

Regulatory and Safety Concerns

Long-term safety and efficacy data, particularly for extended-release formulations, are still being evaluated. Regulatory bodies require more comprehensive studies to fully characterize the potential risks, such as hepatic impairments associated with long-term use[5].

Emerging Trends

Nanodrug Delivery Systems

Emerging trends include the development of nanodrug delivery systems, such as NTX-loaded micelles and nanogels. These systems aim to improve the therapeutic index and selectivity of naltrexone, offering promising sustainable drug carriers for treating opiate and alcohol dependence[2].

Extended-Release Formulations

Extended-release injectable naltrexone (XR-naltrexone) is gaining traction due to its ability to increase treatment initiation rates and improve patient compliance. Studies have shown that initiating XR-naltrexone within 5 to 7 days of seeking treatment significantly increases treatment initiation rates[4].

Regional Analysis

North America

North America accounts for a significant share of the naltrexone hydrochloride market, driven by high awareness among healthcare professionals, favorable reimbursement policies, and increasing prevalence of substance use disorders[4].

Europe

The European market is influenced by healthcare reforms, research advancements, and patient-focused initiatives. The aging population and changing lifestyles in Europe are contributing to the growing demand for effective treatment options[4].

Conclusion

The naltrexone hydrochloride market is poised for significant growth driven by increasing substance use disorders, government initiatives, and advancements in pharmaceutical formulations. While side effects and regulatory concerns are restraints, emerging trends such as nanodrug delivery systems and extended-release formulations are expected to further propel the market.

Key Takeaways

• The naltrexone hydrochloride market is projected to grow from USD 1.5 billion in 2023 to USD 2.59 billion by 2031.
• Key drivers include the increasing prevalence of substance use disorders and government support.
• Advances in pharmaceutical formulations, such as extended-release and injectable forms, are enhancing treatment outcomes.
• North America holds a significant share of the market due to high awareness and favorable reimbursement policies.
• Emerging trends include nanodrug delivery systems and extended-release formulations.

FAQs

What is the current market size of the naltrexone hydrochloride market?

The naltrexone hydrochloride market was valued at USD 1.5 billion in 2023[1].

What is the projected CAGR for the naltrexone hydrochloride market from 2024 to 2031?

The market is expected to grow at a CAGR of 7% from 2024 to 2031[1].

What are the main applications of naltrexone hydrochloride?

Naltrexone hydrochloride is used for alcohol dependence treatment, opioid dependence treatment, opioid overdose reversal, and other applications[1].

Which region holds the largest share of the naltrexone hydrochloride market?

North America holds a significant share of the market due to high awareness and favorable reimbursement policies[4].

What are the potential side effects of naltrexone hydrochloride treatment?

Potential side effects include nausea, dizziness, and abdominal cramps[3].

Sources

1. Market Research Intellect: "Global Naltrexone Hydrochloride Market Size and Projections"
2. Kinam Park: "Naltrexone - A review of existing sustained drug delivery systems and emerging nano-based systems"
3. The Insight Partners: "Naltrexone HCl Market Size and Forecasts (2021 - 2031), Global"
4. Grand View Research: "Naltrexone And Buprenorphine Market Size Report, 2030"
5. Tandfonline: "Update on drug safety evaluation of naltrexone/bupropion for the treatment of obesity"