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Last Updated: December 22, 2024

Naltrexone - Generic Drug Details


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

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

Naltrexone has eighteen patent family members in eleven countries.

There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound. There is one tentative approval for this compound.

Drug Prices for naltrexone

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Drug Sales Revenue Trends for naltrexone

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Recent Clinical Trials for naltrexone

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

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

See all naltrexone clinical trials

Generic filers with tentative approvals for NALTREXONE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe8MG/90MGTABLET, 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.

Medical Subject Heading (MeSH) Categories for naltrexone
Paragraph IV (Patent) Challenges for NALTREXONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIVITROL Extended-release Injectable Suspension naltrexone 380 mg/vial 021897 1 2020-06-18

US Patents and Regulatory Information for naltrexone

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 207621-001 Aug 19, 2016 DISCN No No 7,815,934 ⤷  Subscribe Y ⤷  Subscribe
Pfizer TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No 8,685,443 ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 091205-001 Aug 17, 2011 AB 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

Expired US Patents for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,403,114 ⤷  Subscribe
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,713,090 ⤷  Subscribe
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 6,537,586 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naltrexone

Country Patent Number Title Estimated Expiration
Japan 2011225600 NALTREXONE LONG ACTING FORMULATION AND METHOD OF USE ⤷  Subscribe
Japan 2007533738 ⤷  Subscribe
Russian Federation 2370257 СОСТАВЫ С ПРОЛОНГИРОВАННЫМ ДЕЙСТВИЕМ НА ОСНОВЕ НАЛТРЕКСОНА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (COMPOSITIONS WITH PROLONGED ACTION BASED ON NALTREXONE AND METHODS OF THEIR APPLICATION) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naltrexone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France ⤷  Subscribe PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456 2017/059 Ireland ⤷  Subscribe PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 LUC00054 Luxembourg ⤷  Subscribe PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Naltrexone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Naltrexone

Introduction

Naltrexone, an opioid receptor antagonist, has been a pivotal drug in the treatment of alcohol and opioid dependence. The market dynamics and financial trajectory of naltrexone are influenced by several key factors, including the rising prevalence of substance abuse, government initiatives, technological advancements, and the evolving healthcare landscape.

Market Drivers

Rising Prevalence of Alcohol and Opioid Addiction

The global naltrexone market is significantly driven by the increasing number of individuals struggling with alcohol and opioid addiction. This rise in substance abuse has created a pressing need for effective treatment options, with naltrexone emerging as a key solution[3][4].

Increasing Awareness and Government Initiatives

Growing awareness among healthcare professionals and patients about the efficacy of naltrexone in addiction treatment is fueling market growth. Government initiatives and funding for substance abuse treatment programs further support the market's expansion. In regions like North America and Europe, government and private bodies are actively promoting opioid and alcohol treatment programs, which has boosted the demand for naltrexone[1][3].

Technological Advancements

Technological advancements in drug delivery systems, such as the development of extended-release formulations, have improved patient compliance and enhanced the therapeutic uses of naltrexone. These innovations are expected to continue driving the market forward[3][4].

Regional Analysis

North America

North America dominates the naltrexone market due to a high prevalence of alcohol and opioid addiction and well-established healthcare infrastructure. The U.S. and Canada have seen continuous advancements in healthcare, including significant R&D activities, which have contributed to the region's leading position[1][4].

Europe

Europe is another significant market for naltrexone, with increasing awareness and government initiatives supporting addiction treatment. The region has seen a broad range of interventions, including outpatient treatment and support programs, which have been increasing since 2010[1].

Asia Pacific

The Asia Pacific region is expected to witness substantial growth due to rising addiction rates and increasing healthcare expenditure. Government initiatives in countries like China to spread awareness about drug addiction and its ill effects are likely to augment the naltrexone market in this region[1][3].

Market Restraints and Challenges

Stringent Regulatory Constraints

Stringent regulatory constraints, particularly in developed countries, pose a significant challenge to the naltrexone market. Legal obligations for addiction treatment products can hamper market growth[1].

Side Effects and Safety Concerns

Naltrexone treatment can emerge with several adverse effects, including sleep disturbances, anxiety, nervousness, abdominal pains, nausea, fatigue, joint and muscle pain, and headache. These side effects, especially at high doses, can limit the market's potential[5].

Limited Access to Treatment

In regions like Latin America and the Middle East & Africa, limited awareness about opioid and alcohol dependence treatment and inadequate healthcare infrastructure are projected to restrain the market[1].

Financial Trajectory

Current Market Size and Growth Projections

The global naltrexone market was valued at US$ 21.0 billion in 2023 and is expected to grow at a CAGR of 3.6% from 2024 to 2034, reaching US$ 30.8 billion by the end of the forecast period[4].

Revenue Distribution by Region

North America currently dominates the market, followed by Europe. The Asia Pacific region is expected to grow rapidly due to increasing healthcare expenditure and government initiatives[1][4].

Revenue Distribution by End-User

The hospitals and clinics segment accounted for the largest share of the naltrexone market in 2023, reflecting the primary setting where addiction treatments are administered[4].

Competitive Landscape

Key Players

The market is characterized by the presence of several key players, including Taj Pharmaceuticals, IVAX Paper Chemicals, Faran Shimi, AdooQ Bioscience LLC, Sun Pharmaceutical Industries Ltd., Sanofi S.A., Freedom Pharmaceuticals, Ascent Scientific, Teva Pharmaceutical Industries Ltd., and Mallinckrodt Pharmaceuticals. These companies are engaged in new product launches, expanding production capabilities, and strategic alliances to enhance their market presence[4].

Collaborations and Partnerships

Collaborations with addiction treatment centers and rehabilitation facilities are crucial for the market's growth. These partnerships help in educating healthcare professionals and patients about the benefits of naltrexone and its role in comprehensive addiction treatment programs[3].

Future Outlook

Sustained Growth

The future of the naltrexone market looks promising, with sustained growth expected in the coming years. The increasing prevalence of alcohol and opioid addiction, coupled with rising awareness and government initiatives, will continue to drive market demand. Technological advancements, personalized medicine approaches, and collaborations are anticipated to shape the market’s future landscape, offering enhanced treatment options and improved patient outcomes[3].

Untapped Markets

Emerging markets present significant growth opportunities for naltrexone. Targeted marketing, awareness campaigns, and partnerships with local healthcare providers can help penetrate these markets and open up new avenues for growth[3].

"The naltrexone market is witnessing significant growth driven by the rising prevalence of alcohol and opioid addiction. Naltrexone, an opioid antagonist, plays a crucial role in addiction treatment by reducing cravings and preventing relapse."[3]

Key Takeaways

  • The global naltrexone market is driven by the rising prevalence of alcohol and opioid addiction.
  • Government initiatives and increasing awareness about naltrexone's efficacy are key market drivers.
  • Technological advancements, such as extended-release formulations, are enhancing the market.
  • North America and Europe are the leading regions, with Asia Pacific expected to grow rapidly.
  • The market faces challenges related to side effects and limited access to treatment in some regions.
  • The competitive landscape is characterized by key players engaging in new product launches and strategic alliances.

FAQs

1. What are the primary drivers of the naltrexone market?

The primary drivers of the naltrexone market include the rising prevalence of alcohol and opioid addiction, increasing awareness about naltrexone's efficacy, government initiatives, and technological advancements in drug delivery systems.

2. Which regions dominate the naltrexone market?

North America and Europe currently dominate the naltrexone market, with North America leading due to its well-established healthcare infrastructure and high prevalence of substance abuse.

3. What are the challenges facing the naltrexone market?

The naltrexone market faces challenges such as stringent regulatory constraints, side effects and safety concerns, and limited access to treatment in certain regions.

4. How is the competitive landscape of the naltrexone market?

The competitive landscape is characterized by key players such as Taj Pharmaceuticals, Sun Pharmaceutical Industries Ltd., and Teva Pharmaceutical Industries Ltd., who are engaged in new product launches, expanding production capabilities, and strategic alliances.

5. What is the projected growth rate of the naltrexone market?

The global naltrexone market is expected to grow at a CAGR of 3.6% from 2024 to 2034, reaching US$ 30.8 billion by the end of the forecast period.

Cited Sources:

  1. Biospace - Naltrexone Market: Rise in alcohol & opioid dependence to drive the market
  2. Frontiers in Psychiatry - The Effects of Naltrexone Among Alcohol Non-Abstainers
  3. Markwide Research - Naltrexone market 2024-2032 | Size, Share, Growth
  4. Transparency Market Research - Naltrexone Market Size, Share and Growth Report, 2034
  5. Taylor & Francis Online - Update on drug safety evaluation of naltrexone/bupropion for the treatment of obesity

More… ↓

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