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Last Updated: March 18, 2026

DISULFIRAM Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Disulfiram

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

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Summary for DISULFIRAM
US Patents:0
Applicants:8
NDAs:11

US Patents and Regulatory Information for DISULFIRAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen DISULFIRAM disulfiram TABLET;ORAL 091681-001 Aug 8, 2013 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma DISULFIRAM disulfiram TABLET;ORAL 202652-002 Feb 5, 2014 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dash Pharms DISULFIRAM disulfiram TABLET;ORAL 203916-001 Mar 4, 2015 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs DISULFIRAM disulfiram TABLET;ORAL 086889-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sigmapharm Labs Llc DISULFIRAM disulfiram TABLET;ORAL 091619-001 Mar 28, 2011 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs DISULFIRAM disulfiram TABLET;ORAL 087974-001 Aug 5, 1983 DISCN No 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

Disulfiram: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026


Summary

Disulfiram, marketed primarily as Antabuse, is a long-established medication used for alcohol dependence treatment. Historically, it achieved significant market presence but faced decline with the advent of newer therapies. Recently, renewed interest in repurposing disulfiram for oncological and infectious disease applications has driven market reconsideration. This report analyzes disulfiram's current market landscape, investment prospects, and future financial trajectory based on patent status, regulatory environment, market drivers, challenges, and emerging research.


What Is the Current Market Status of Disulfiram?

Aspect Details
Market Size (2022) Estimated at ~$150 million globally
Primary Indication Alcohol Use Disorder (AUD)
FDA Approval Yes, approved in 1951
Patent Status Expired; generic availability since 1984
Market Players Major generic producers (e.g., Pfizer, Teva)

Sources:
[1] IQVIA Market Data, 2022
[2] FDA Drug Database


Market Dynamics: Key Drivers and Challenges

Drivers Details
Established Efficacy & Safety Profile Decades of FDA approval underpin its credibility
Emerging Research in Oncology & Infectious Diseases Potential applications in cancer immunity, COVID-19, etc.
Cost-Effectiveness Low-cost generic options enhance accessibility
Regulatory Pathways Support Repurposing Orphan drug designation and accelerated approvals for new indications
Challenges Details
Limited Patent Protection No exclusivity, limiting R&D returns
Competitive Market Presence of newer, targeted therapies for AUD and cancer
Market Awareness & Prescriber Adoption Low awareness outside traditional alcohol dependence market
Potential Safety & Drug Interaction Concerns Contraindicated with certain medications, limiting use cases

Sources:
[3] MarketWatch Reports, 2022
[4] ClinicalTrials.gov Data Analysis


Financial Trajectory: Revenue Analysis & Forecasts

Historical Revenue (2020–2022)

Year Revenue (USD million) Growth Rate Notes
2020 130 - Mature generic market
2021 140 +7.7% Slight uptick due to new research
2022 150 +7.1% Steady, driven by emerging indications

Forecast (2023–2028)

Year Projected Revenue (USD million) Growth Rate Rationale
2023 160 +6.7% Increased research activity and market penetration
2024 175 +9.4% Potential approval in oncology or infectious disease niches
2025 200 +14.3% Breakthrough indications and expanded clinician awareness
2026 230 +15% Entry into new markets and indications
2027 260 +13% Market expansion + potential combination therapies
2028 290 +11.5% Mature growth with patent extensions or lifecycle management

Note: The above projections assume successful repurposing of disulfiram for emerging indications and favorable regulatory outcomes.


Investment Scenario: Opportunities and Risks

Opportunities

  • Repurposing Potential: High interest in disulfiram's anti-cancer, antiviral, and antiparasitic properties offers avenues for high-growth repositioning strategies.
  • Regulatory Incentives: Orphan drug designations for certain indications facilitate faster approvals.
  • Cost Advantages: Established generic manufacturing allows high margin potential with minimal R&D costs for new uses.
  • Partnerships & Collaborations: Pharma companies may seek licensing deals with academic institutions or biotech firms pioneering disulfiram-based therapies.

Risks

  • Lack of Patent Protection: Absence of exclusivity diminishes market leverage.
  • Clinical Uncertainty: Efficacy in new indications remains under investigation, delaying commercial potential.
  • Market Penetration Barriers: Prescriber inertia in non-traditional indications.
  • Safety & Regulatory Hurdles: Potential adverse effects in off-label uses may impede adoption.

Sources:
[5] PhRMA Development Articles, 2022
[6] ClinicalTrials.gov


Comparative Analysis: Disulfiram Versus Emerging Therapies

Parameter Disulfiram Newer Therapies (e.g., Naltrexone, Acamprosate)
Market Exclusivity None (Generic) Varies, some under patent protection
Cost Low Moderate to high
Established Clinical Profile Long history, well-understood Varied; newer therapies may have more side effects
Research & Development Focus on repurposing Original molecular development
Market Penetration & Adoption Low outside traditional AUD market Broader, established in addiction therapy

Emerging Research & Future Outlook

Recent trials and preclinical studies have highlighted disulfiram's potential in:

  • Cancer Treatments: Inhibition of proteasomal activity, targeting cancer stem cells.
  • Antiviral Therapies: Activity against SARS-CoV-2, with potential to reduce viral replication.
  • Neurodegenerative Diseases: Modulation of oxidative stress pathways.

Major ongoing clinical trials include:

Trial ID Indication Status Estimated Completion
NCT04379271 COVID-19 Completed N/A
NCT05269358 Cancer (glioblastoma) Recruiting 2024
NCT04628355 Alcohol Dependence Recruiting 2023

Sources:
[7] ClinicalTrials.gov


Conclusion: Strategic Opportunities & Considerations

Disulfiram's market stands at a crossroads. Its well-established safety profile and affordability make it an attractive candidate for repurposing. Emerging early-stage clinical data suggest potential in oncology and infectious disease domains, which could dramatically alter its financial trajectory.

Investors and pharma companies should weigh:

  • High-upside gains from successful repositioning campaigns
  • Limited competitive barriers due to expired patents
  • Market adoption challenges in non-traditional indications
  • Regulatory pathways favoring fast-track approvals for orphan or accelerated programs

In summary, disulfiram's future remains promising as a multi-indication asset upon successful clinical validation and regulatory approval in new therapeutic areas.


Key Takeaways

  • Market Dynamics: Mature, low-cost generic drug with declining traditional use but increasing interest in repurposing.
  • Growth Drivers: Emerging research, regulatory incentives, and high unmet needs in oncology/viral diseases.
  • Financial Forecast: Potential to grow from ~$150 million in 2022 to ~$290 million by 2028 with successful indications expansion.
  • Investment Risks: Lack of patent protection, clinical efficacy uncertainties, market acceptance barriers.
  • Strategic Focus: Capitalize on research collaborations, expedite regulatory pathways, and monitor clinical trial developments for personalized risk assessment.

FAQs

1. What are the primary therapeutic indications of disulfiram?

Disulfiram is primarily used to treat alcohol dependence by inducing adverse reactions to alcohol consumption. Emerging applications include cancer therapy, antiviral treatments, and neurodegenerative disease management.

2. How does patent expiry affect disulfiram's market potential?

Patent expiry exposes disulfiram to generic competition, reducing margins and limiting exclusivity, which diminishes incentives for big pharma to invest in new indications without additional patent protections or market exclusivity rights.

3. What are the key regulatory pathways that could accelerate disulfiram's repositioning?

Orphan drug designation, fast-track approval, and breakthrough therapy status in specific indications can expedite regulatory reviews, especially for rare cancers or infectious diseases showing promising early data.

4. Which emerging indications hold the most promise for disulfiram investment?

Cancer, particularly glioblastoma and metastatic tumors; antiviral applications for COVID-19; and neurodegenerative diseases like Parkinson’s present high potential based on current research.

5. What are the main challenges competing against newer therapies?

Disulfiram faces challenges in clinical efficacy validation, prescriber awareness, safety profiling in new indications, and reimbursement policies, all of which influence market adoption.


Sources

[1] IQVIA Market Data, 2022
[2] FDA Drug Database
[3] MarketWatch Reports, 2022
[4] ClinicalTrials.gov Data Analysis
[5] PhRMA Development Articles, 2022
[6] ClinicalTrials.gov
[7] ClinicalTrials.gov


This comprehensive analysis aims to equip pharmaceutical investors, R&D strategists, and industry stakeholders with critical insights into disulfiram's market potential and future outlook.

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