You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

NALTREXONE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Naltrexone Hydrochloride patents expire, and when can generic versions of Naltrexone Hydrochloride launch?

Naltrexone Hydrochloride is a drug marketed by Accord Hlthcare, Barr, Chartwell, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm. and is included in seven NDAs.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Naltrexone Hydrochloride

A generic version of NALTREXONE HYDROCHLORIDE was approved as naltrexone hydrochloride by BARR on May 8th, 1998.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for NALTREXONE HYDROCHLORIDE?
  • What are the global sales for NALTREXONE HYDROCHLORIDE?
  • What is Average Wholesale Price for NALTREXONE HYDROCHLORIDE?
Drug patent expirations by year for NALTREXONE HYDROCHLORIDE
Recent Clinical Trials for NALTREXONE HYDROCHLORIDE

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

SponsorPhase
University of UtahPhase 1
Brigham and Women's HospitalPhase 1
National Institute of Mental Health (NIMH)Phase 2

See all NALTREXONE HYDROCHLORIDE clinical trials

Pharmacology for NALTREXONE HYDROCHLORIDE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE HYDROCHLORIDE

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
Accord Hlthcare NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 091205-001 Aug 17, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-002 Mar 22, 2002 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Elite Labs NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274-001 May 26, 1999 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-003 Mar 22, 2002 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 074918-001 May 8, 1998 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 207905-001 Jul 21, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 076264-001 Mar 22, 2002 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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"

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.