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Last Updated: December 12, 2025

ANTABUSE Drug Patent Profile


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Which patents cover Antabuse, and when can generic versions of Antabuse launch?

Antabuse is a drug marketed by Odyssey Pharms and Teva Womens and is included in three NDAs.

The generic ingredient in ANTABUSE is disulfiram. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the disulfiram profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Antabuse

A generic version of ANTABUSE was approved as disulfiram by SIGMAPHARM LABS LLC on March 28th, 2011.

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Summary for ANTABUSE
Drug patent expirations by year for ANTABUSE
Recent Clinical Trials for ANTABUSE

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

SponsorPhase
National Institute on Alcohol Abuse and Alcoholism (NIAAA)EARLY_PHASE1
Columbia UniversityEARLY_PHASE1
University of RochesterPHASE1

See all ANTABUSE clinical trials

US Patents and Regulatory Information for ANTABUSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Odyssey Pharms ANTABUSE disulfiram TABLET;ORAL 088482-001 Dec 8, 1983 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Womens ANTABUSE disulfiram TABLET;ORAL 007883-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Odyssey Pharms ANTABUSE disulfiram TABLET;ORAL 088483-001 Dec 8, 1983 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Womens ANTABUSE disulfiram TABLET;ORAL 007883-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Antabuse (Disulfiram)

Last updated: August 4, 2025

Introduction

Antabuse, the brand name for disulfiram, remains an integral pharmacological tool in the treatment of alcohol dependence. First approved by the U.S. Food and Drug Administration (FDA) in 1951, disulfiram has maintained a long-standing presence in addiction management through its unique mechanism of action, which creates an adverse reaction to alcohol consumption. Despite its age, Antabuse continues to exhibit sustained market relevance, influenced by evolving healthcare dynamics, regulatory landscapes, and societal needs.

Market Overview and Industry Context

The global pharmaceutical market for alcohol dependence therapies is witnessing incremental changes driven by increased awareness around alcohol-related health issues, advancements in pharmacotherapies, and behavioral intervention programs. As per recent reports, the global alcohol dependence treatment market is projected to reach USD 1.5 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of approximately 7% from 2022[1].

Within this landscape, disulfiram's role remains significant, particularly for structured inpatient settings and patient populations seeking a long-term aversion therapy. It acts by inhibiting aldehyde dehydrogenase, causing acetaldehyde accumulation upon alcohol intake, which leads to discomfort and discourages continued drinking.

Market Dynamics Influencing Antabuse

1. Regulatory and Patent Landscape

Disulfiram’s patent exclusivity expired decades ago, permitting generic manufacturers' entry. This patent expiry has resulted in a commoditized market with low per-unit pricing, constraining revenue potential for brand-specific Antabuse products. Current market shares primarily comprise generic formulations, though some branded variants still hold niche positions due to established prescriber familiarity and patient trust.

Regulatory agencies continue to scrutinize disulfiram’s safety profile, especially concerning hepatic toxicity and adverse drug interactions. The absence of new formulations or delivery mechanisms limits regulatory innovation, thus anchoring Antabuse’s market role in traditional formulations.

2. Demographic and Societal Trends

The global surge in alcohol consumption, especially in emerging markets, fuels the demand for effective treatment options. Moreover, increasing awareness of alcohol use disorders (AUD) and stigma reduction efforts have expanded treatment-seeking behavior. The World Health Organization estimates that over 283 million people globally suffer from alcohol use disorders, underscoring an increasing patient base[2].

However, adherence remains a significant hurdle. Disulfiram requires strict compliance, often necessitating supervised administration, which limits its utility in unsupervised settings and restrains market expansion.

3. Advances in Therapeutics and Alternatives

New pharmacotherapies such as naltrexone (oral and injectable) and acamprosate offer alternative mechanisms for alcohol dependence management, often with broader tolerability profiles and better adherence. These agents have gained clinically predominant roles, especially in outpatient settings where compliance can be actively monitored.

Emerging therapies such as long-acting injectable formulations, digital health interventions, and combination therapies are reshaping the treatment landscape, posing competitive challenges for disulfiram-based approaches.

4. Patient Compliance and Safety Concerns

Disulfiram’s reliance on patient adherence and its potential for hepatotoxicity significantly impact market traction. Modern treatment paradigms favor medications with more favorable side effect profiles, contributing to the plateau or decline in Antabuse utilization in some markets.

5. Impact of Digital and Telemedicine Platforms

The COVID-19 pandemic accelerated non-traditional healthcare delivery models, including telemedicine. While these platforms improve access to alcohol dependence treatment, they favor medications with easier adherence and tolerability—factors that do not always favor disulfiram.

Financial Trajectory and Market Outlook

Historical Revenue Performance

Antabuse’s revenue has historically been stagnant, primarily consisting of generic sales with minimal innovation-driven growth. In the United States, branded Antabuse sales peaked in the late 20th century but have since declined significantly due to the proliferation of alternative agents and generic competition.

Current Market Valuation

The market valuation for disulfiram products remains modest. In the U.S., annual sales of disulfiram-based formulations hover around USD 50-100 million, primarily driven by specialized inpatient facilities and psychiatric clinics[3].

Globally, the market is fragmented, with notable presences in Europe, Asia-Pacific, and Latin America, where healthcare infrastructure and prescribing practices vary.

Future Revenue Potential

Forecasts suggest that, absent significant innovations, Antabuse’s market share is likely to remain stable or decline modestly, constrained by competitive dynamics. Nonetheless, niche opportunities exist in certain outpatient and correctional settings where supervised administration and adherence programs are feasible.

Potential drivers for future growth include:

  • Partnership with digital health tools for adherence monitoring
  • Expansion into emerging markets with rising alcohol consumption
  • Development of combination therapies enhancing efficacy or tolerability

However, without new formulations or delivery innovations, revenues are uncertain to surpass historical levels.

Strategic Factors Shaping the Market

  • Pricing pressures: Generic availability limits profit margins, restricting investments into new formulations.
  • Regulatory focus: Emphasis on safety has led to risk-based prescribing guidelines, influencing market access.
  • Market segmentation: Adoption in inpatient, correctional, and specialized clinics sustains a niche but stable market.

Conclusion

The financial trajectory of Antabuse is characterized by stability in niche markets rather than broad industry growth. Its future depends heavily on targeted implementation in supervised settings, integration with adherence-enhancing technologies, and strategic positioning within emerging markets. Nonetheless, persistent competition from newer agents and concerns over compliance and safety challenge widespread market expansion.

Key Takeaways

  • Stable Niche: Antabuse’s market remains stable within specific clinical settings; however, its share in the broader alcohol dependence treatment market is plateauing.
  • Generic Dominance: Patent expiration has led to commoditized generic formulations, constraining revenue growth prospects.
  • Competitive Alternatives: Naltrexone and acamprosate have become preferred due to better tolerability and compliance profiles, limiting Antabuse’s broader adoption.
  • Innovation Opportunities: Integration with digital adherence tools and targeted administration models can sustain niche relevance.
  • Market Expansion in Emerging Regions: Rising alcohol consumption and increasing healthcare infrastructure in developing countries present growth opportunities, contingent on regulatory and pricing considerations.

FAQs

1. Will Antabuse regain market share in the future?
While unlikely to regain significant market share on a broad scale, Antabuse can maintain or grow its niche presence through targeted supervised administration and integration with adherence support technologies.

2. Are there ongoing efforts to develop new formulations of disulfiram?
Currently, most efforts focus on delivery improvements and combination therapies. No major new formulations have been approved recently, limiting innovation-driven growth.

3. How does the safety profile of Antabuse affect its market?
Concerns over hepatotoxicity and adverse interactions restrict its use to specific patient populations and supervised settings, limiting widespread prescribing.

4. Can digital health platforms enhance Antabuse’s market viability?
Yes. Digital adherence tools can improve compliance, potentially expanding its use in outpatient and community settings.

5. What role do regulatory agencies play in shaping Antabuse’s market?
Regulatory agencies focus on safety monitoring and prescribing guidelines that influence its utilization, especially highlighting the need for supervised administration in certain populations.


References
[1] Global Alcohol Dependence Treatment Market Report, 2022-2027
[2] WHO, Global Status Report on Alcohol and Health, 2018
[3] IQVIA, Pharmaceutical Market Analytics, 2022

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