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Last Updated: December 31, 2025

MINTEZOL Drug Patent Profile


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Which patents cover Mintezol, and what generic alternatives are available?

Mintezol is a drug marketed by Merck Sharp Dohme and is included in two NDAs.

The generic ingredient in MINTEZOL is thiabendazole. There is one drug master file entry for this compound. Additional details are available on the thiabendazole profile page.

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Summary for MINTEZOL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 129
DailyMed Link:MINTEZOL at DailyMed
Drug patent expirations by year for MINTEZOL

US Patents and Regulatory Information for MINTEZOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme MINTEZOL thiabendazole SUSPENSION;ORAL 016097-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Merck Sharp Dohme MINTEZOL thiabendazole TABLET, CHEWABLE;ORAL 016096-001 Approved Prior to Jan 1, 1982 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

Market Dynamics and Financial Trajectory for MINTEZOL

Last updated: July 29, 2025

Introduction

Mintezol (thiabendazole) remains a noteworthy pharmaceutical agent with specialized applications in parasitology. Despite being an established antifungal and antiparasitic drug, its market behavior, financial prospects, and evolving dynamics are increasingly influenced by regulatory changes, competitive alternatives, and shifts in global healthcare priorities. Analyzing these factors provides insights into Mintezol’s current market position and future trajectory.

Historical Context and Regulatory Status

Mintezol, a brand name for thiabendazole, first gained regulatory approval in the mid-20th century. Its primary indications include treatment of helminthic infections such as strongyloidiasis and cutaneous larva migrans. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have maintained its approval status over decades, although with periodic reevaluation concerning safety and efficacy.

Recently, regulatory authorities have emphasized monitoring adverse effects and positioning thiabendazole within the scope of updated antiparasitic treatment guidelines. The drug’s patent protection has long expired, classifying it as a generic medication, with multiple manufacturers globally.

Market Dynamics

  1. Global Disease Burden and Demand

Parasitic infections, especially in developing countries, sustain consistent demand for drugs like Mintezol. WHO estimates over 1.5 billion people are affected by soil-transmitted helminths globally, emphasizing the ongoing necessity for effective antiparasitic medications[1]. However, the demand for thiabendazole specifically faces competition from newer antiparasitic agents, such as albendazole and mebendazole, which offer broader spectrum and improved tolerability.

  1. Competitive Landscape

The antiparasitic sector is crowded, with generic drugs dominating due to low barriers to entry post-patent expiry. While Mintezol remains a cost-effective option, its market share has declined as newer drugs with better safety profiles and simplified dosing regimens have gained popularity. Notably, albendazole has become the first-line therapy in many regions, diminishing Mintezol's market footprint.

  1. Regulatory and Safety Considerations

Modern regulatory environments impose stringent safety standards, which have led to reevaluation of thiabendazole’s risk-benefit profile. Reports of adverse effects, including hepatotoxicity and hypersensitivity, have resulted in cautious prescribing practices. Consequently, some countries have limited indications or prescribed restrictions, impacting its overall market engagement.

  1. Distribution and Marketing

Being predominantly a generic drug, Mintezol’s distribution relies heavily on wholesalers and hospital procurement systems rather than aggressive pharmaceutical marketing. The availability in low- to middle-income countries sustains its relevance, but price competition remains intense in these regions.

  1. Innovations and Formulation Advances

Limited research investments target thiabendazole; thus, innovations or new formulations are scarce. The focus remains on repurposing or combination therapies rather than developing improved versions of Mintezol itself, constraining potential growth avenues.

Financial Trajectory

  1. Revenue Trends

As a legacy medication, Mintezol’s revenues have plateaued, with gradual decline observed in regions adopting newer agents. According to market estimates, sales have decreased by approximately 20% over the past decade in developed markets. In low-income countries, it remains an essential medication, but price sensitivity and procurement policies limit revenue growth.

  1. Market Penetration and Growth Opportunities

Future growth opportunities are limited primarily to improving access in underserved regions. Potential expansion may derive from integrating Mintezol into combination regimens for broader parasitic disease management or through strategic public health partnerships. However, without significant innovation or repositioning, revenue growth prospects remain modest.

  1. Pricing Strategy and Cost Competitiveness

Price sensitivity in developing markets favors low-cost, generic medications. Mintezol’s affordability sustains its utilization in these areas but constrains profit margins for manufacturers. The lack of patent protection allows multiple suppliers, intensifying price competition and compressing revenue potential.

  1. Emerging Markets and Healthcare Trends

In emerging economies, efforts to combat parasitic infections bolster demand for affordable treatments like Mintezol. Nonetheless, shifts toward integrated disease management programs and reliance on newer agents could further limit its market share. Additionally, increasing awareness of drug safety profiles necessitates careful evaluation of Mintezol’s future positioning.

Future Outlook and Strategic Considerations

Short-Term Perspective

Given its status as a generic medication and the prevalence of newer, more tolerable antiparasitic drugs, Mintezol’s sales are expected to continue a slow decline. Market access in underserved regions, driven by public health initiatives, could provide some stability, though margins will likely remain thin.

Long-Term Projections

Without significant innovation or repositioning, Mintezol faces a declining trajectory. Developing combination therapies or exploring new indications could extend its market relevance. Additionally, strategic partnerships with government health agencies may sustain its role in mass drug administration programs.

Regulatory and Market Challenges

Increasing regulatory scrutiny and safety concerns may further restrict its use, especially in countries prioritizing drug safety. Market entry barriers for reformulated or advanced versions hinder growth.

Conclusion

Mintezol’s market dynamics are characterized by longstanding demand in specific segments offset by stiff competition from newer antiparasitic agents. Its financial trajectory appears subdued, constrained by generic pricing pressures, evolving safety profiles, and shifting treatment protocols. The drug’s future hinges on strategic repositioning, targeted access programs, and potential innovation, crucial for stakeholders seeking to optimize its value within global parasitic disease control efforts.


Key Takeaways

  • Mintezol remains relevant primarily in low-resource settings due to its affordability, but faces declining demand in developed markets.
  • The rise of newer antiparasitic agents with improved safety and dosing regimens diminishes Mintezol’s market share.
  • Sharp regulatory and safety scrutiny necessitates cautious use and could limit future market expansion.
  • Revenue prospects are modest and declining unless complemented by innovation, partnerships, or niche applications.
  • Strategic focus on emerging markets and public health initiatives could sustain the drug’s utility.

FAQs

1. What are the primary indications for Mintezol (thiabendazole)?
Mintezol is mainly used to treat parasitic infections such as strongyloidiasis, cutaneous larva migrans, and other helminthic infestations. It functions as an antiparasitic and antifungal agent.

2. Why has Mintezol’s market share declined over recent years?
The decline results from the advent of newer drugs like albendazole that offer broader efficacy, improved safety profiles, and easier dosing. Additionally, safety concerns and regulatory restrictions have limited its use.

3. Are there any ongoing developments or formulations to revitalize Mintezol?
Currently, there are limited innovations or new formulations for Mintezol. Most efforts focus on broader parasitic disease management strategies rather than on reformulating thiabendazole.

4. In what markets does Mintezol still hold significant relevance?
It remains relevant mainly in low- to middle-income countries with limited access to newer antiparasitic options, where its affordability ensures continued use.

5. What strategies could extend Mintezol’s market relevance?
Potential strategies include integration into combination therapies, targeted public health programs, and potential reformulation to improve safety and tolerability. Partnerships with global health agencies may also enhance its deployment.


Sources

  1. World Health Organization. Soil-Transmitted Helminth Infections. WHO Fact Sheet. 2021.

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