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Last Updated: December 11, 2025

Albendazole - Generic Drug Details


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What are the generic drug sources for albendazole and what is the scope of freedom to operate?

Albendazole is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Cipla Ltd, Dr Reddys, Edenbridge Pharms, MSN, Strides Pharma, Zydus Pharms, and Impax Labs Inc, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for albendazole. Eleven suppliers are listed for this compound.

Summary for albendazole
Drug Prices for albendazole

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Recent Clinical Trials for albendazole

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

SponsorPhase
Kirby InstitutePHASE3
Medicines Development for Global HealthPHASE3
Murdoch Childrens Research InstitutePHASE3

See all albendazole clinical trials

Pharmacology for albendazole
Drug ClassAnthelmintic
Mechanism of ActionCytochrome P450 1A Inducers
Medical Subject Heading (MeSH) Categories for albendazole

US Patents and Regulatory Information for albendazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth ALBENDAZOLE albendazole TABLET;ORAL 208094-001 May 20, 2019 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Impax Labs Inc ALBENZA albendazole TABLET;ORAL 020666-001 Jun 11, 1996 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Msn ALBENDAZOLE albendazole TABLET;ORAL 213435-001 Jan 21, 2021 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dr Reddys ALBENDAZOLE albendazole TABLET;ORAL 211034-001 Jan 26, 2021 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx ALBENDAZOLE albendazole TABLET;ORAL 211636-001 Jun 10, 2020 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 Albendazole

Last updated: August 13, 2025

Introduction

Albendazole, a broad-spectrum anthelmintic agent, is pivotal in combating a wide array of parasitic worm infections. Its widespread use in both human and veterinary medicine, coupled with expanding indications and emerging markets, makes it a significant subject for pharmaceutical market analysis. This article explores the market dynamics shaping Albendazole’s trajectory, the factors influencing its financial outlook, and strategic implications for stakeholders.

Pharmacological Profile and Clinical Use

Albendazole, chemically classified as a benzimidazole carbamate, interferes with parasite microtubule formation, leading to parasite death. Globally, it is authorized for treating diseases such as neurocysticercosis, hydatid disease, soil-transmitted helminthiasis, and other geohelminthic infections. Its oral bioavailability, safety profile, and affordability contribute to its widespread acceptance (WHO, 2021).

Global Market Overview

The global Albendazole market exhibits steady growth driven by the high prevalence of parasitic infections, particularly in low- to middle-income countries. According to a report by Grand View Research, the anti-infective pharmaceuticals market, including Albendazole, is projected to see a compound annual growth rate (CAGR) of approximately 5% over the next five years (2022–2027). This growth is underscored by increasing public health initiatives and the integration of deworming programs into national health policies.

Market Segmentation

  • Geographical Distribution: The Asia-Pacific region dominates due to a high burden of parasitic diseases, followed by Africa, Latin America, and parts of Southeast Asia. Developed regions like North America and Europe have limited but consistent demand, primarily for imported or imported-use formulations.
  • Application Sectors: Human health applications constitute roughly 70–80% of the market, with veterinary applications growing at a CAGR of approximately 4% annually, driven by increased livestock rearing and zoonotic disease control.

Drivers of Market Growth

Prevalence of Parasitic Infections

The World Health Organization estimates over 1.5 billion people are affected by soil-transmitted helminths globally. Regions with inadequate sanitation infrastructure, such as parts of sub-Saharan Africa and Southeast Asia, continue to experience high infection rates, fueling demand for Albendazole.

Public Health Initiatives

Global health organizations, including WHO and UNICEF, lead mass deworming campaigns targeting school-age children and vulnerable populations. These programs significantly boost Albendazole procurement, distribution, and use, sustaining consistent market demand.

Product Approvals and Generic Availability

The patent expiration of several formulations has resulted in increased manufacturing of generic Albendazole by multiple companies, reducing costs and expanding access, especially in resource-limited settings.

Expanding Indications

Recent research suggests Albendazole’s potential off-label uses, such as adjunct therapy in certain parasitic co-infections and protozoal infections. Such advancements could diversify application scope, expanding market prospects.

Market Challenges and Constraints

Emergence of Drug Resistance

Monitoring parasitic resistance is a growing concern. While resistance to Albendazole remains relatively low globally, reports of decreased efficacy in some regions threaten long-term utility, necessitating surveillance and development of combination therapies.

Regulatory and Supply Chain Barriers

Stringent regulatory approvals, especially in high-income countries, can delay market entry of new formulations. Additionally, supply chain disruptions, exacerbated by global events such as the COVID-19 pandemic, have impacted manufacturing and distribution.

Price Sensitivity and Affordability

In low-income regions, price remains a critical factor. While generics have minimized costs, funding limitations for large-scale deworming campaigns could constrain market expansion.

Financial Trajectory and Investment Outlook

Revenue Projections

Global revenues from Albendazole are projected to grow incrementally, reaching an estimated $300–500 million annually within the next five years, primarily driven by emerging markets. The segment for veterinary applications is expected to increase at a CAGR of 4%, reflecting livestock industry growth.

Key Market Players

Major pharmaceutical companies, including GlaxoSmithKline, Mylan (now part of Viatris), and Teva Pharmaceuticals, dominate Albendazole production. Contract manufacturing organizations and regional players are increasingly market entrants due to low entry barriers post-patent expiry.

Investment Opportunities and Risks

Investments in generic manufacturing and regional distribution networks offer growth opportunities. Conversely, patent disputes, resistance development, and regulatory hurdles pose potential risks. Companies investing in formulation innovations, such as sustained-release tablets, could realize premium pricing.

Regulatory and Policy Impact

Government health policies, such as mass drug administration (MDA) programs, influence market demand. Recent WHO advocacy for integrated neglected tropical disease (NTD) control strategies further supports market stability.

Future Trends and Innovations

Formulation and Delivery Enhancements

Research into novel delivery systems—such as sustained-release formulations and combination therapies—aims to improve compliance and efficacy. Enhanced bioavailability formulations could expand use cases and dosage flexibility.

Digital and Data-Driven Programs

Integration of digital health tools in surveillance, adherence monitoring, and supply chain management can optimize distribution channels, especially within decentralized healthcare systems.

Global Disease Elimination Goals

As WHO aims for the eradication of certain parasitic diseases by 2030, Albendazole’s role becomes strategically significant. Increased funding and global coordination may enhance procurement volumes.

Conclusion: Strategic Market and Financial Outlook

Albendazole’s market remains robust owing to endemic parasitic infections, public health initiatives, and generic manufacturing. While resistance and regulatory factors present challenges, innovation and strategic collaborations can mitigate these risks. The financial trajectory appears favorable, with gradual growth in both human and veterinary sectors, particularly in emerging economies. Stakeholders should prioritize surveillance of resistance patterns, investment in formulation innovations, and strengthening supply chains to harness market potential fully.

Key Takeaways

  • High Global Demand: Driven by persistent parasitic infections in developing regions and supported by large-scale deworming initiatives.
  • Generic Expansion: Patent expiries have catalyzed widespread manufacturing, reducing costs and increasing access.
  • Emerging Applications: Continued research may broaden Albendazole's therapeutic scope.
  • Resistance Monitoring: Vigilant surveillance necessary to sustain long-term efficacy.
  • Growth Opportunities: Formulation innovations and digital health integration promise future market expansion.

FAQs

  1. What factors most significantly influence Albendazole's market growth?
    The primary drivers include high disease prevalence in developing regions, public health deworming campaigns, and the proliferation of generic manufacturing reducing costs.

  2. How does drug resistance impact Albendazole's market outlook?
    Resistance emergence threatens efficacy, potentially leading to decreased demand and prompting development of combination therapies or new agents.

  3. What opportunities exist for new market entrants in Albendazole?
    Opportunities include manufacturing cost-effective generics, developing innovative formulations, and expanding into veterinary markets with increasing livestock demand.

  4. Are regulatory hurdles a major concern for Albendazole's market penetration?
    Regulatory approvals can delay market entry, especially in high-income regions, but existing generic formulations face fewer barriers, facilitating broader access.

  5. What strategic actions should stakeholders consider for long-term success?
    Stakeholders should invest in resistance monitoring, formulation advancements, and strengthening supply chains, while aligning with global health initiatives for sustained demand.


References:

  1. World Health Organization. (2021). "Prevalence and Control of Parasitic Infections."
  2. Grand View Research. (2022). "Anti-infectives Market Analysis."

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