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Last Updated: December 12, 2025

VERMOX Drug Patent Profile


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When do Vermox patents expire, and what generic alternatives are available?

Vermox is a drug marketed by Janssen Pharms and is included in two NDAs.

The generic ingredient in VERMOX is mebendazole. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mebendazole profile page.

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Questions you can ask:
  • What is the 5 year forecast for VERMOX?
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Summary for VERMOX
US Patents:0
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 142
Clinical Trials: 6
What excipients (inactive ingredients) are in VERMOX?VERMOX excipients list
DailyMed Link:VERMOX at DailyMed
Drug patent expirations by year for VERMOX
Recent Clinical Trials for VERMOX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
RDD Pharma LtdPhase 2
Yale UniversityPhase 4
HopeXchange Medical Center, GhanaPhase 4

See all VERMOX clinical trials

Pharmacology for VERMOX
Drug ClassAnthelmintic

US Patents and Regulatory Information for VERMOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms VERMOX mebendazole TABLET, CHEWABLE;ORAL 017481-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Janssen Pharms VERMOX mebendazole TABLET, CHEWABLE;ORAL 208398-001 Oct 19, 2016 DISCN Yes 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

International Patents for VERMOX

See the table below for patents covering VERMOX around the world.

Country Patent Number Title Estimated Expiration
Germany 2029637 METHYL-N-5 (6)-ACYL-2-BENZIMIDAZOLYLCARBAMATE ⤷  Get Started Free
Netherlands 7009024 ⤷  Get Started Free
Austria 307798 ⤷  Get Started Free
South Africa 7004191 ⤷  Get Started Free
Yugoslavia 34195 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for VERMOX (Mebendazole)

Last updated: August 12, 2025


Introduction

VERMOX, primarily containing the active pharmaceutical ingredient (API) mebendazole, is a broad-spectrum anthelmintic agent utilized for the treatment of various parasitic worm infections. Historically approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), VERMOX has maintained a significant position in global parasitic disease management. This article analyzes the evolving market dynamics and forecasts the financial trajectory of VERMOX, considering current trends, competing therapies, regulatory considerations, and emerging market opportunities.


Market Landscape Overview

Global Parasitic Disease Burden and Treatment Needs

Parasitic infections, including ascariasis, hookworm, trichuriasis, and pinworm, significantly impact public health, especially in low- and middle-income countries (LMICs). The World Health Organization (WHO) estimates over a billion people are infected with soil-transmitted helminths globally, underscoring a persistent demand for effective, low-cost anthelmintic treatments (WHO, 2020). Although numerous antihelmintics exist, mebendazole remains a frontline agent owing to its efficacy, affordability, and safety profile.

Regulatory and Patent Landscape

The patent status of mebendazole varies across jurisdictions. In the U.S., the original patent expired decades ago, leading to widespread availability as a generic product. Several pharmaceutical companies manufacture generic mebendazole, intensifying price competition. However, some formulations and combination therapies still hold proprietary rights, providing differentiation opportunities. Regulatory agencies have approved various formulations, including oral tablets and suspensions, broadening treatment options.


Market Drivers

Increase in Parasitic Disease Prevalence

The endemic prevalence of soil-transmitted helminthiasis drives consistent demand for VERMOX, especially in regions with limited access to sanitation infrastructure. The WHO advocates mass deworming campaigns, which rely heavily on affordable drugs like mebendazole, creating a steady demand pipeline.

Emerging Resistance Concerns

While resistance to mebendazole remains relatively low compared to other anthelmintics, reports of decreased efficacy in certain regions urge ongoing surveillance. The potential emergence of resistance could necessitate combination therapies or new formulations, influencing market dynamics.

Public Health Initiatives and Global Funding

WHO and UNICEF campaigns aim to deworm vulnerable populations, often subsidizing or procuring generic VERMOX in LMICs. International health organizations' commitment to controlling neglected tropical diseases sustains and potentially expands the market for mebendazole-based therapies.

Product Development and Formulation Innovations

Innovations, such as extended-release formulations and combination therapies (e.g., with albendazole or praziquantel), aim to improve efficacy, compliance, and spectrum of activity. These developments can offer premium pricing and market differentiation.


Market Challenges

Competitive Pressure from Generics and Alternative Therapies

The commoditization of mebendazole due to patent expirations introduces significant price erosion. Alternative agents, such as albendazole, ivermectin, and pyrantel pamoate, offer comparable efficacy, intensifying competitive pressure.

Regulatory Restrictions and Quality Assurance

Variation in quality standards across markets can affect brand reputation, especially with the proliferation of generic products. Stringent quality assurance and regulatory compliance are critical to sustain market share.

Limited Feasibility of Market Expansion in Developed Countries

In developed nations, the incidence of parasitic infections has declined significantly due to improved sanitation and healthcare infrastructure. Consequently, the core market is concentrated in LMICs, limiting growth in high-income regions.


Financial Trajectory and Forecasts

Revenue Projections

Given the broad use of generic mebendazole in humanitarian campaigns and endemic regions, revenue generation is expected to be stable but modest. The global market for anthelmintics, valued at approximately $1 billion in 2022, is anticipated to grow at a compound annual growth rate (CAGR) of 3-4% driven by increasing disease prevalence and public health initiatives (MarketWatch, 2022) [1].

Specialty formulations, such as combination therapies or sustained-release formats, could command premium pricing, leading to accelerated revenue growth in niche segments. Emerging markets are projected to constitute a significant percentage of revenue, with revenues potentially reaching $1.2-$1.5 billion worldwide by 2028, assuming stable access to global funding and high compliance rates.

Profitability Outlook

Profit margins for generic mebendazole manufacturing are generally thin due to pricing pressures. However, formulations with enhanced efficacy, better bioavailability, or added convenience could command higher margins. Larger pharmaceutical firms with established global distribution networks and supply chain efficiencies are better positioned to maintain profitability.

Future Growth Opportunities

  • Combination therapies: Developing fixed-dose combinations (FDCs) with other antiparasitic agents could extend market reach and provide strategic differentiation.
  • Innovation in formulations: Extended-release tablets or pediatric-friendly suspensions could expand use in vulnerable populations.
  • Expanding Access in Emerging Markets: Collaborations with governments and NGOs can facilitate volume growth, particularly through subsidized programs.
  • Potential for New Indications: Research on mebendazole's antiparasitic activity against other parasites or even anticancer properties presents future pathways for expansion, albeit with regulatory hurdles.

Regulatory and Commercial Considerations

Regulatory approval pathways remain straightforward for generic mebendazole in regions with established quality standards. However, novel formulations or combination products require comprehensive clinical trials and regulatory filings, which entail jeopardized timelines and higher costs.

Commercial strategies should focus on leveraging existing global health funding sources, forging partnerships with organizations such as WHO, and emphasizing the cost-effectiveness and safety profile of VERMOX to maintain market relevance.


Conclusion

The market for VERMOX, driven by global health needs and endemic parasitic disease burdens, is characterized by stability amid intense generic competition. Margins are under pressure, with growth potential primarily rooted in emerging markets, formulation innovation, and strategic collaborations. Public health initiatives will remain pivotal in sustaining demand. Companies operating in this space must prioritize quality assurance, cost management, and innovation to capitalize on the evolving landscape.


Key Takeaways

  • The global demand for VERMOX remains steady, fueled by endemic parasitic diseases primarily affecting LMICs.
  • Patent expirations have led to commoditization, with competition mainly from generic manufacturers.
  • Opportunities for growth include developing combination therapies, innovative formulations, and expanding access in emerging markets.
  • Public health campaigns and international funding substantially influence sales volumes, ensuring a baseline revenue stream.
  • Maintaining quality standards and engaging with global health initiatives are crucial for long-term market positioning.

FAQs

1. What factors influence the pricing of VERMOX in different markets?
Pricing is heavily influenced by generic competition, regulatory standards, procurement mechanisms by governments and NGOs, and the level of local healthcare infrastructure. Subsidies and bulk procurement in LMICs often lead to lower prices compared to high-income countries.

2. How does emerging resistance affect the future of VERMOX?
While resistance to mebendazole remains relatively low globally, localized reports emphasize the need for ongoing surveillance. Resistance could necessitate development of combination therapies or new formulations, impacting market dynamics.

3. Are there innovative formulations of VERMOX in development?
Yes, research includes extended-release formulations and pediatric-friendly suspensions that aim to improve compliance and efficacy, potentially creating new market segments.

4. What role do international health organizations play in the VERMOX market?
Organizations like WHO facilitate mass deworming programs, procure large quantities of generic VERMOX, and support disease control initiatives, significantly influencing demand and market stability.

5. Can VERMOX utility extend beyond parasitic infections?
Preliminary studies suggest potential antiparasitic activity against other parasites and possible anticancer properties. However, these applications are experimental and require rigorous clinical validation and regulatory approval.


Sources

[1] MarketWatch. (2022). Global Anthelmintic Drugs Market Size, Share & Trends Analysis Report.

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