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Last Updated: December 22, 2024

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. Four 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
Universidad de GuanajuatoEarly Phase 1
Laboratorios Doctor MacĂ­asEarly Phase 1
University of California, San FranciscoPhase 2

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Womens ANTABUSE disulfiram TABLET;ORAL 007883-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Odyssey Pharms ANTABUSE disulfiram TABLET;ORAL 088483-001 Dec 8, 1983 DISCN Yes 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

ANTABUSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Antabuse (Disulfiram)

Introduction to Antabuse

Antabuse, also known by its generic name disulfiram, is a medication used to treat alcohol use disorders (AUD) by producing unpleasant side effects when alcohol is consumed. This drug has been a cornerstone in the treatment of alcoholism for decades, but its market dynamics and financial trajectory have faced significant challenges recently.

Mechanism of Action and Uses

Disulfiram works by blocking the conversion of acetaldehyde to acetic acid, leading to an accumulation of acetaldehyde, which causes severe side effects such as headaches, nausea, vomiting, and other discomforts when alcohol is ingested. This mechanism serves as a strong deterrent to drinking[3].

Market Size and Growth

The global disulfiram market was estimated at USD 375.19 million in 2023 and is expected to reach USD 392.75 million in 2024, with a projected Compound Annual Growth Rate (CAGR) of 4.81% to reach USD 521.63 million by 2030. This growth is driven by increasing awareness of substance abuse treatment options and ongoing research into new therapeutic uses and formulations[4].

Market Drivers

Several factors are driving the growth of the disulfiram market:

  • Growing Awareness and Treatment Initiatives: There is a rising awareness about substance abuse treatment options, which has led to an increased demand for disulfiram.
  • Ongoing Research and Clinical Trials: Research into new therapeutic applications, such as treating cocaine addiction and potential uses in cancer therapy, is expanding the market.
  • Insurance Coverage Expansions: Broadening insurance coverage for alcohol dependence treatments has made disulfiram more accessible to a wider population[4].

Market Restraints

Despite the growth drivers, the market faces several restraints:

  • Potential Side Effects: Disulfiram's severe side effects when alcohol is consumed can limit its prescription and patient adherence.
  • Regulatory and Economic Constraints: Economic and regulatory challenges, including pricing and reimbursement issues, affect the market performance of disulfiram.
  • Supply Chain Vulnerabilities: Recent supply chain issues, such as those faced by Sanofi, have impacted the availability of the drug[1][4].

Recent Developments and Challenges

Sanofi's Decision to Stop Production

Sanofi, a major producer of Antabuse, has decided to stop its worldwide production due to stock shortages, long-term supply issues with the raw compound disulfiram, and the presence of carcinogenic nitrosamines in the drug. This decision has been met with concern from healthcare professionals and patients who rely on the medication[1].

Impact on Patients

The discontinuation of Antabuse by Sanofi is seen as a significant setback for patients who depend on the drug. According to Frieda Matthys, a professor of Psychiatry at the Vrije Universiteit Brussel, "The drug provides peace of mind and for some is the difference between functioning or relapse. For them, this is a disaster."[1]

Alternative Options

Patients are advised to switch to alternative drugs or obtain similar medications from other manufacturers, such as those in the Netherlands. However, these alternatives may not be as effective or readily available, posing a challenge for those in need[1].

Financial Aspects

Cost of Antabuse

The cost of Antabuse varies widely depending on the brand name, generic version, dose, and insurance coverage. A month's supply of brand-name Antabuse can cost between $100 to $200 or more, while the generic version, disulfiram, is significantly cheaper, ranging from $30 to $80 for a 30-day supply[2].

Insurance Coverage

Most private health insurance plans cover Antabuse or its generic equivalent, disulfiram. Medicaid and Medicare also provide coverage, though the copays vary by plan. The cost savings from using generic versions and leveraging insurance coverage can make the treatment more affordable[2].

Market Opportunities

Despite the challenges, there are several opportunities for growth and innovation in the disulfiram market:

  • Emerging Markets: Increasing awareness and access to disulfiram in emerging markets can drive growth.
  • New Formulations: Developing long-acting formulations, such as oral disintegrating tablets or injectables, can improve patient compliance.
  • Combination Therapies: Research into combination therapies featuring disulfiram and other pharmacological agents can expand its therapeutic applications[4].

Key Players and Competitive Landscape

The disulfiram market includes several key players such as Abbott Laboratories, Alkem Laboratories Ltd., Allergan plc, and Sanofi S.A., among others. These companies are involved in various stages of research, development, and distribution of disulfiram. The competitive landscape is influenced by factors such as innovative profiles, market strategies, and regulatory compliance[4].

Conclusion

The market dynamics and financial trajectory of Antabuse are complex and influenced by multiple factors. While the drug faces challenges such as supply chain issues and potential side effects, it also has significant growth potential driven by increasing awareness and ongoing research. The recent decision by Sanofi to stop production highlights the need for alternative solutions and innovative strategies to ensure continued access to this critical medication.

Key Takeaways

  • Growing Demand: The disulfiram market is growing due to increasing awareness of substance abuse treatment options.
  • Challenges: Supply chain issues, potential side effects, and regulatory constraints impact the market.
  • Financial Considerations: The cost of Antabuse varies, but generic versions and insurance coverage can make it more affordable.
  • Innovation Opportunities: Developing new formulations and combination therapies can expand the market.
  • Alternative Options: Patients may need to switch to alternative drugs or obtain medications from other manufacturers.

FAQs

Q: Why is Sanofi stopping the production of Antabuse? A: Sanofi is stopping the production of Antabuse due to stock shortages, long-term supply issues with the raw compound disulfiram, and the presence of carcinogenic nitrosamines in the drug[1].

Q: How does Antabuse work? A: Antabuse works by blocking the conversion of acetaldehyde to acetic acid, leading to an accumulation of acetaldehyde, which causes severe side effects when alcohol is ingested[3].

Q: What are the alternatives to Antabuse? A: Patients can switch to alternative drugs with different active substances or obtain similar medications from other manufacturers, such as those in the Netherlands[1].

Q: How much does Antabuse cost? A: The cost of Antabuse varies, with brand-name versions costing between $100 to $200 or more per month, while generic versions cost between $30 to $80 per month[2].

Q: Is Antabuse covered by insurance? A: Yes, most private health insurance plans, Medicaid, and Medicare cover Antabuse or its generic equivalent, disulfiram, though copays vary by plan[2].

Sources

  1. The Brussels Times: "Antabuse drug to stay off alcohol no longer available, a 'disaster' for alcoholics"
  2. Boca Recovery Center: "How Much Does Antabuse Cost?"
  3. American Addiction Centers: "Disulfiram (Antabuse): Side Effects & Uses for Alcoholism Treatment"
  4. 360iResearch: "Disulfiram Market Size & Share 2025-2030"

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