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Thiabendazole - Generic Drug Details
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What are the generic drug sources for thiabendazole and what is the scope of freedom to operate?
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
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rigshospitalet, Denmark | Phase 2/Phase 3 |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Merck Sharp Dohme | MINTEZOL | thiabendazole | TABLET, CHEWABLE;ORAL | 016096-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Thiabendazole Market Dynamics and Financial Trajectory
Thiabendazole, an anthelmintic and antifungal agent, exhibits a stable market presence driven by its established efficacy, particularly in veterinary medicine and specific niche human applications. While not a high-growth blockbuster, its consistent demand and cost-effectiveness contribute to a predictable financial trajectory.
What are the primary applications of thiabendazole?
Thiabendazole's primary applications span multiple sectors.
- Veterinary Medicine: It is widely used to treat parasitic worm infections in livestock, including cattle, sheep, and horses. Common targets are gastrointestinal nematodes and lungworms. Its application in this sector represents the largest portion of its market share.
- Human Medicine: In human healthcare, thiabendazole is prescribed for the treatment of strongyloidiasis, a parasitic infection. It also has applications in treating cutaneous larva migrans and toxocariasis. Off-label uses include management of certain fungal infections, though this is less common than its anthelmintic role.
- Agriculture: Although less prevalent now due to newer fungicides, thiabendazole has historically been used as a post-harvest fruit treatment to prevent fungal decay, particularly in citrus fruits and bananas. This application has seen a decline due to regulatory changes and the availability of alternative treatments.
- Material Preservation: Limited use exists in preserving materials like textiles and paper against fungal degradation.
Who are the key manufacturers and suppliers of thiabendazole?
The manufacturing landscape for thiabendazole is characterized by a mix of established chemical companies and generic drug producers. Key players include:
- Merck & Co. (MSD): Historically a significant developer and producer, though its direct market presence has evolved.
- Generic Pharmaceutical Manufacturers: A substantial portion of global thiabendazole production is handled by companies specializing in generic active pharmaceutical ingredients (APIs). These are often based in India and China. Specific company names are proprietary and vary with market demand, but notable API suppliers in these regions are consistently involved.
- Formulators: Companies that produce the finished dosage forms (tablets, suspensions, topical creams) often source their API from these larger manufacturers. These can range from regional pharmaceutical companies to global distributors.
Data on specific market share by manufacturer is not publicly granular due to the generic nature of much of its production. However, the supply chain is characterized by a concentration of API production in Asia.
What is the historical market size and growth rate of thiabendazole?
The market for thiabendazole has demonstrated a consistent, albeit modest, growth trajectory.
- Historical Market Size: Precise historical market size figures are difficult to isolate as thiabendazole is often grouped within broader anthelmintic or antiparasitic drug categories in market research reports. However, estimates for the global anthelmintics market, which thiabendazole contributes to, indicate a multi-billion dollar valuation. Thiabendazole's specific contribution is estimated in the tens of millions to low hundreds of millions of US dollars annually.
- Growth Rate: The growth rate for thiabendazole has historically been in the low single digits (1-3% CAGR). This steady growth is attributable to its continued use in established veterinary protocols and its critical role in treating neglected tropical diseases in certain regions. Factors that temper higher growth include the emergence of newer, more potent, or broader-spectrum antiparasitic drugs in both human and veterinary medicine, and the decline in agricultural applications.
What are the primary drivers of thiabendazole market demand?
Demand for thiabendazole is influenced by several key factors:
- Prevalence of Parasitic Infections: The ongoing prevalence of parasitic worm infections in livestock globally, particularly in developing economies, is a primary driver. Effective and affordable treatment is essential for animal health and agricultural productivity.
- Veterinary Health Protocols: Routine deworming programs in livestock management necessitate a consistent supply of effective anthelmintics like thiabendazole.
- Neglected Tropical Diseases (NTDs): In specific geographic regions, thiabendazole remains a critical treatment option for NTDs such as strongyloidiasis. Global health initiatives focused on these diseases indirectly support its demand.
- Cost-Effectiveness: Compared to newer therapeutic agents, thiabendazole is generally more affordable, making it a preferred choice in price-sensitive markets and for large-scale veterinary use.
- Established Safety Profile: For its approved indications, thiabendazole has a well-documented safety profile, contributing to its continued use by healthcare professionals and veterinarians.
What are the key challenges and restraints for the thiabendazole market?
Several factors constrain the market growth of thiabendazole.
- Emergence of Newer Drugs: The development of novel anthelmintics with broader spectrums of activity, enhanced efficacy, or improved resistance profiles poses a competitive threat.
- Antiparasitic Resistance: Like many antiparasitic agents, resistance to thiabendazole can develop in target parasite populations. This can limit its long-term efficacy and necessitate treatment rotation or alternative drug use.
- Regulatory Scrutiny and Environmental Concerns: While less of a restraint for its core medicinal uses, its historical agricultural applications have faced increased environmental and residue-related regulatory hurdles in some jurisdictions.
- Limited Pipeline and Innovation: Thiabendazole is a mature drug, and significant investment in new R&D for novel applications or formulations is limited. Its market expansion relies more on existing uses than on breakthrough discoveries.
- Competition from Other Established Drugs: Within its therapeutic classes, thiabendazole competes with other widely available and often equally effective generic anthelmintics.
What is the future financial outlook and projected market trajectory for thiabendazole?
The future financial outlook for thiabendazole is one of continued stability with modest growth.
- Projected Market Size: The market is expected to maintain its current valuation range, with projections indicating a CAGR of 1.5% to 3% over the next five to seven years. This growth will be largely driven by sustained demand in veterinary applications and its essential role in specific human health contexts.
- Geographic Trends: Demand is anticipated to remain strong in regions with significant livestock populations and a higher burden of parasitic diseases. Emerging economies in Asia, Africa, and Latin America will likely represent key growth areas for its veterinary applications.
- Therapeutic Shifts: While its core indications will persist, significant expansion into new therapeutic areas is not anticipated. The focus will remain on optimizing its use within current paradigms.
- API Production Landscape: The dominance of API manufacturing in India and China is expected to continue, ensuring competitive pricing and consistent supply.
- Investment Considerations: For investors, thiabendazole represents a stable, albeit low-return, asset. Its value lies in its predictable demand and established market position rather than high-growth potential. Companies involved in its generic production or formulation can expect steady revenue streams.
What are the patent landscapes and intellectual property considerations for thiabendazole?
Thiabendazole is a well-established compound, and its primary composition of matter patents have long expired.
- Composition of Matter: The fundamental patent protection for thiabendazole expired decades ago.
- Method of Use Patents: While expired, older method of use patents may still exist in some jurisdictions for specific applications. However, these are unlikely to be a significant barrier to generic competition for established uses.
- Formulation and Process Patents: Newer patents may cover specific pharmaceutical formulations, manufacturing processes, or novel delivery systems for thiabendazole. These can offer a degree of protection for innovative forms of the drug, but they do not prevent the production of generic standard formulations.
- Genericization: The market is heavily characterized by generic competition, with multiple manufacturers producing and selling thiabendazole APIs and finished products. This has led to price erosion over time, making it a cost-competitive option.
- Exclusivity: Brand-name exclusivity is virtually nonexistent for thiabendazole in most markets, with the exception of potentially very niche, newly approved formulations or combination therapies, which are rare.
Key Takeaways
- Thiabendazole maintains a stable market, primarily driven by its widespread use in veterinary medicine for livestock deworming and its critical role in treating specific human parasitic infections.
- The market is characterized by consistent, low single-digit growth (1-3% CAGR), with future projections indicating continued stability rather than rapid expansion.
- Cost-effectiveness and an established safety profile are key demand drivers, particularly in price-sensitive markets and for large-scale applications.
- Key restraints include competition from newer antiparasitic agents, the development of drug resistance, and limited innovation in new therapeutic applications.
- The intellectual property landscape is dominated by expired composition of matter patents, leading to a highly genericized market. Manufacturing is concentrated in API production hubs in Asia.
Frequently Asked Questions
How does thiabendazole compare to other anthelmintics in terms of efficacy?
Thiabendazole is effective against a range of nematodes and some cestodes. Its efficacy can vary depending on the specific parasite species and the development of resistance. Newer broad-spectrum anthelmintics may offer wider coverage or higher efficacy against certain resistant strains. For example, macrocyclic lactones like ivermectin and moxidectin are often preferred for certain veterinary indications due to their broader spectrum and longer duration of action, but thiabendazole remains a viable and cost-effective option for specific nematode infections.
What is the typical pricing range for thiabendazole API and finished products?
Pricing for thiabendazole API is highly competitive due to generic manufacturing. Bulk API prices typically range from $50 to $200 per kilogram, depending on the supplier, purity, and volume. Finished product pricing varies significantly based on dosage form, country, and regulatory approvals. For example, a pack of 30 human-grade tablets might range from $5 to $20, while veterinary formulations can be priced per dose or per animal treatment.
Are there any significant environmental concerns associated with thiabendazole use?
Historically, concerns related to thiabendazole's use as a post-harvest fruit treatment included residue levels on produce and potential environmental impact. While these concerns led to reduced agricultural use in some regions, its application in veterinary medicine and human health is generally considered safe when used according to prescribed guidelines. Environmental monitoring data specific to widespread veterinary or human therapeutic use is limited, but typical drug metabolism and excretion pathways are understood.
What are the primary routes of administration for thiabendazole?
Thiabendazole is administered orally in both human and veterinary medicine, typically as tablets or suspensions. Topical formulations (creams, lotions) are also available for certain dermatological conditions and parasitic skin infections. Parenteral administration is not a standard route due to formulation challenges and potential for adverse effects.
How does the regulatory status of thiabendazole differ between human and veterinary medicine?
In human medicine, thiabendazole is regulated as a prescription drug by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approved indications such as strongyloidiasis. In veterinary medicine, it is also regulated but often through different pathways, allowing for broader use in food-producing animals. Approval for veterinary use requires demonstration of safety and efficacy in target species, as well as establishment of withdrawal periods for food animals.
Citations
[1] World Health Organization. (2020). Anthelmintics. Retrieved from https://www.who.int/news-room/fact-sheets/detail/anthelmintics [2] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ [3] European Medicines Agency. (n.d.). Human medicines. Retrieved from https://www.ema.europa.eu/en/human-regulatory [4] Generally Accepted Market Research Industry Practices. (Ongoing). Estimates for API and finished drug product markets.
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