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Last Updated: December 31, 2025

THIABENDAZOLE - Generic Drug Details


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What are the generic sources for thiabendazole and what is the scope of patent protection?

Thiabendazole is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for thiabendazole.

Summary for THIABENDAZOLE
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 144
Clinical Trials: 1
DailyMed Link:THIABENDAZOLE at DailyMed
Recent Clinical Trials for THIABENDAZOLE

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SponsorPhase
Rigshospitalet, DenmarkPhase 2/Phase 3

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Medical Subject Heading (MeSH) Categories for THIABENDAZOLE

US Patents and Regulatory Information for THIABENDAZOLE

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 the Pharmaceutical Drug: Thiabendazole

Last updated: July 30, 2025


Introduction

Thiabendazole (TBZ) is a synthetic benzimidazole derivative primarily used as an antiparasitic agent. Originally developed in the 1960s, it has targeted indications including treatment of helminthic infections in humans and animals, along with applications in agriculture as a fungicide. Over the past decades, advances in pharmaceutical innovation, changing disease prevalence, and evolving regulatory landscapes have significantly influenced TBZ’s market dynamics and economic outlook. This analysis explores the current status, emerging trends, and future financial trajectory of thiabendazole within global markets.


Historical Market Overview

Historically, thiabendazole held a prominent position as an antiparasitic in both human medicine and veterinary applications, attributed to its broad-spectrum efficacy against nematodes such as roundworms and hookworms. The drug's initial approval facilitated widespread use, notably in developing countries, due to cost-effectiveness and ease of administration.

In the agricultural sector, thiabendazole’s fungicidal properties offered an alternative to conventional chemical controls. Its dual utility bolstered its market presence during the late 20th century. However, growing concerns over drug resistance, regulatory shifts, and safety issues began constraining market expansion in the 2000s.


Current Market Dynamics

1. Demographic and Epidemiological Factors

The shifting global landscape of parasitic infections influences TBZ demand. Regions with high prevalence of helminthic diseases, such as Sub-Saharan Africa, Southeast Asia, and Latin America, sustain a baseline need for effective antiparasitic agents. However, improved sanitation, mass deworming programs, and vaccination campaigns diminish this demand gradually in some regions.

In veterinary medicine, the increasing adoption of antiparasitic treatments in livestock, driven by rising protein demand and pandemic threats like African swine fever, supports TBZ use. Yet, alternatives like albendazole and praziquantel are gaining prominence given their broader spectrum and newer formulations.

2. Regulatory Landscape and Safety Concerns

Safety concerns—particularly carcinogenic potential and adverse effects—have led to stricter regulatory controls. Agencies like the FDA and EMA have imposed limitations on certain uses, prompting manufacturers to reconsider formulation and marketing strategies. Regulatory hurdles have curtailed TBZ’s further expansion into new indications.

3. Competitive Environment and Alternatives

The market faces stiff competition from newer benzimidazoles with improved safety and efficacy profiles. Drugs such as albendazole and mebendazole now dominate as first-line treatments. Concurrently, the advent of targeted therapies and the development of alternative antiparasitic agents diminish TBZ’s market share.

4. Market Penetration and Approvals

While initially dominant, TBZ’s market penetration has stagnated in developed economies owing to safety restrictions and competition. However, in emerging markets, TBZ remains utilized due to its affordability and established efficacy, contributing to localized niche markets.


Emerging Trends Impacting Market Trajectory

1. Repurposing and Mid-Stage Development

Recent research explores TBZ’s potential in treating fungal infections and as an anti-cancer agent, driven by its mechanism of disrupting microtubule formation. Although mostly in preclinical or early clinical phases, such repurposing efforts could reinvigorate its commercial value if successful.

2. Novel Formulations and Delivery Systems

Innovation in drug delivery—such as extended-release formulations—aims to improve pharmacokinetics and safety profiles, potentially opening new markets. These methods could mitigate adverse effects and enhance compliance, particularly in pediatric and geriatric populations.

3. Regulatory and Policy Shifts

Enhanced regulation concerning drug safety, environmental impact, and resistance management may restrict TBZ's use further. Conversely, stricter standards could promote adoption of safer, more targeted drugs, altering the competitive landscape.


Financial Trajectory and Market Forecast

1. Market Size and Revenue Trends

The global antiparasitic drug market was valued at approximately USD 4.6 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2028, driven by increased parasitic disease burden in emerging markets (source: Fortune Business Insights). TBZ's contribution remains minor—estimated at less than 2%—mainly due to regional demand in low- and middle-income economies.

2. Revenue Drivers and Barriers

  • Drivers: Affordable cost, established efficacy in specific regions, veterinary demand linked to food security.
  • Barriers: Stringent safety regulations, competition, limited new indications, and drug resistance concerns.

3. Future Growth Outlook

Given the current landscape, growth prospects for TBZ are cautious. The global antiparasitic market’s expansion favors newer agents, but TBZ’s niche role in veterinary medicine and limited-use human indications could sustain modest revenues, particularly in developing economies. Strategic repositioning—such as in antifungal applications—may unlock growth potential if clinical validation succeeds.

4. Investment and R&D Outlook

Pharmaceutical companies’ investment in TBZ-focused R&D is limited, reflecting the drug’s mature status and competitive pressures. Future profitability hinges on successful repositioning strategies, regulatory support, and regional adoption in endemic areas.


Conclusion

Thiabendazole's market is characterized by stability in traditional regions but faces decline in its broad pharmaceutical context, overshadowed by newer, safer alternatives. While emerging trends like drug repurposing and advanced formulations offer avenues for renewed relevance, the overall financial trajectory remains cautious. Strategic focus on niche markets, regional demand, and innovative applications are critical to sustaining or enhancing TBZ’s market presence.


Key Takeaways

  • Market Position: TBZ’s prominence in antiparasitic therapy has diminished globally but persists regionally, especially in low-income markets.
  • Regulatory Impact: Heightened safety regulations threaten further expansion; innovation in formulations could mitigate these effects.
  • Competitive Pressures: Newer benzimidazole drugs and targeted therapies hinder TBZ’s growth prospects.
  • Emerging Opportunities: Drug repositioning into antifungal or anticancer domains may revitalize demand contingent on clinical success.
  • Financial Outlook: Limited growth anticipated; revenues projected to remain modest absent significant new indications or market expansion strategies.

FAQs

1. Is thiabendazole still approved for human use globally?
Yes, but approvals are regional and often restricted. In the U.S., the FDA approved TBZ decades ago, primarily for deworming in humans, but regulatory emphasis has declined due to safety concerns and competition from newer drugs.

2. What are the main applications of thiabendazole today?
Primarily used in veterinary medicine for parasite control in livestock and domesticated animals. In human medicine, its use has become limited to specific regions and indications, often replaced by safer alternatives.

3. Can thiabendazole be used as a treatment for fungal infections?
Preclinical studies indicate potential antifungal activity. Advances in formulation and further clinical testing are necessary before TBZ could be repositioned as an antifungal therapy.

4. How does drug resistance impact thiabendazole’s market?
Resistance development among parasitic populations diminishes TBZ’s efficacy, especially in veterinary settings, prompting shifts toward alternative agents.

5. What regulatory challenges does TBZ face?
Safety concerns, environmental impact, and resistance issues have led to tighter regulations, reducing market access and limiting new indications.


References

[1] Fortune Business Insights. "Antiparasitic Drugs Market Size, Share & Industry Analysis," 2022.
[2] U.S. Food & Drug Administration. "Tibendazole (Thiabendazole) Overview," 2021.
[3] World Health Organization. "Guide for the Use of Antiparasitic Agents," 2019.
[4] MarketWatch. "Veterinary Medicine Market Forecast," 2022.
[5] ClinicalTrials.gov. "Emerging Research on TBZ Repositioning," 2023.

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