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Last Updated: December 12, 2025

ALBENZA Drug Patent Profile


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

Albenza is a drug marketed by Impax Labs Inc and is included in one NDA.

The generic ingredient in ALBENZA is albendazole. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the albendazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Albenza

A generic version of ALBENZA was approved as albendazole by ZYDUS PHARMS on December 14th, 2018.

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Summary for ALBENZA
Drug patent expirations by year for ALBENZA
Drug Prices for ALBENZA

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Recent Clinical Trials for ALBENZA

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SponsorPhase
Lihir Medical CentrePhase 3
Imperial College LondonPhase 3
Bill and Melinda Gates FoundationPhase 3

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Pharmacology for ALBENZA
Drug ClassAnthelmintic
Mechanism of ActionCytochrome P450 1A Inducers

US Patents and Regulatory Information for ALBENZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc ALBENZA albendazole TABLET;ORAL 020666-001 Jun 11, 1996 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

Market Dynamics and Financial Trajectory for Albenza (Albendazole)

Last updated: July 29, 2025

Introduction

Albenza, the brand name for albendazole, is a broad-spectrum anthelmintic medication primarily prescribed to treat a variety of parasitic worm infections, including cystic echinococcosis, neurocysticercosis, and其他 soil-transmitted helminthiases. Since its approval, Albenza has established a critical niche within infectious disease management, with its market evolution driven by epidemiological trends, technological advancements, regulatory frameworks, and competitive pressures. This comprehensive analysis examines the current market dynamics and projects the financial trajectory of Albenza within the global pharmaceutical landscape.

Market Overview

Therapeutic Indications and Global Burden

Albenza addresses parasitic infections affecting millions globally. According to the World Health Organization (WHO), over a billion individuals are affected by soil-transmitted helminths alone, with significant disease burden in low- and middle-income countries (LMICs) [1]. Neurocysticercosis remains the leading parasitic neurological disease worldwide, particularly in Latin America, sub-Saharan Africa, and Asia, contributing to Epilepsy cases [2].

The escalating prevalence of parasitic diseases, coupled with increased awareness and improved diagnostic capabilities, sustains demand for effective anthelmintic therapies like albendazole. Moreover, the expanding indications—such as off-label use for protozoal infections and emerging parasitic strains—potentially broaden the market scope.

Regulatory Status and Market Access

Albenza has secured approvals from major regulatory agencies globally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These approvals underpin its widespread availability, though access varies significantly in LMICs due to regulatory, economic, and infrastructural barriers [3].

Patents have historically constrained generic entry; however, patent expirations in some markets have increased availability of cost-effective generics, intensifying competitive pressures.

Market Dynamics

Epidemiological Drivers

The steady yet regionally uneven increase in parasitic infections sustains a resilient demand for albendazole. For instance, in areas endemic with neurocysticercosis, rising urbanization and migration contribute to increased case loads. Conversely, global initiatives targeting parasitic disease eradication and mass drug administration (MDA) campaigns have accelerated demand in endemic regions [4].

Technological and Formulation Advances

Vertical integration of diagnostic and treatment pathways has improved target identification, optimizing albendazole use. Innovations include sustained-release formulations, combination therapies, and improved delivery mechanisms enhancing patient compliance and efficacy. Such advancements potentially expand clinical applications and market penetration.

Competitive Landscape

While Albenza remains a cornerstone therapy, the availability of inexpensive generic albendazole significantly influences market share. Although some competitors develop alternative drugs such as mebendazole and praziquantel, albendazole’s broad efficacy and established safety profile sustain its dominance, especially in complex parasitic diseases requiring long-term management.

Pricing and Reimbursement Patterns

Pricing strategies are localized, heavily influenced by regional healthcare policies. In high-income countries, reimbursement supports higher prices, while in LMICs, generic alternatives and bulk procurement policies exert downward pressure on prices, affecting revenue streams.

Impact of COVID-19 Pandemic

The pandemic disrupted healthcare access worldwide, leading to delays in diagnosis and treatment of parasitic diseases. However, increased global health focus on infectious diseases and the continuation of public health initiatives have mitigated some negative impacts, with a potential long-term increase in demand driven by increased disease awareness.

Financial Trajectory

Revenue Trends

Historical data indicates that Albenza’s global revenues have been stable, with minor fluctuations attributable to patent cycles, generic competition, and regional access disparities. The drug's core markets—North America, Europe, and select Asia-Pacific countries—constitute approximately 70% of revenues [5].

Market Expansion Opportunities

Emerging markets present substantial growth opportunities. Rising parasitic infection prevalence, coupled with increasing healthcare infrastructure investment, are expected to elevate demand. The expansion of MDA programs, particularly in sub-Saharan Africa and Southeast Asia, could significantly boost Albenza sales.

Regulatory and Patent Outlook

Patent expirations in key markets are anticipated over the next 3–5 years, likely ushering in enhanced generic competition. While this may pressure prices and margins temporarily, increased accessibility and volume sales could sustain overall revenue growth in the medium to long term.

Investment and R&D Outlook

Pharmaceutical companies are investing in optimizing formulations, such as combination therapies with other antiparasitics, to enhance efficacy and patient adherence. Such innovations have the potential to extend market longevity, diversify application scope, and generate higher margins.

Forecasting and Future Projections

Projections suggest a compound annual growth rate (CAGR) of approximately 4–6% over the next five years for the albendazole market, driven by epidemiological trends and treatment expansion. Revenue growth will be tempered by price erosion due to generic competition but buoyed by increased regional disease burden and MDA initiatives.

Strategic Challenges and Considerations

  • Pricing Pressures: As patent protections lapse, generic competition will likely decrease prices, influencing profit margins.
  • Regulatory Hurdles: Variability in approval processes and access barriers in LMICs could limit market diversification.
  • Resistance Development: Emerging resistance among parasites necessitates ongoing surveillance and development of adjunct therapies.
  • Supply Chain Risks: Managing consistent supply, especially for geographically constrained markets, remains critical.

Key Takeaways

  • The global demand for albendazole remains robust due to the high prevalence of parasitic infections, especially in endemic regions.
  • Patent expirations and resulting generic entries will catalyze price competition but may also expand market access.
  • Innovations in formulations and combination therapies represent promising avenues for extending Albenza’s market lifecycle.
  • Regional health initiatives, notably MDA programs, will significantly influence sales volume and revenue trajectory.
  • Companies must adapt to regional regulatory landscapes, manage supply chain logistics, and monitor resistance patterns to sustain long-term growth.

Conclusion

Albenza is positioned for steady growth over the coming years, driven by persistent epidemiological needs and expanding treatment paradigms. While competitive pressures and patent expirations pose challenges, strategic investments in formulation improvements, market expansion, and regulatory navigation can sustain its financial trajectory. Stakeholders should prioritize regional market dynamics, adaptive pricing strategies, and R&D investments to capitalize on the global parasitic disease management opportunity.


FAQs

1. What are the primary indications for Albenza?
Albenza is primarily indicated for treating neurocysticercosis, cystic echinococcosis, and soil-transmitted helminth infections such as ascariasis, hookworm, and whipworm.

2. How does generic competition affect Albenza’s market?
Patent expirations have led to the entry of cost-effective generics, increasing market accessibility but exerting downward pressure on prices and profit margins for branded Albenza.

3. Are there emerging resistance issues with albendazole?
Yes, resistance among certain parasitic populations has been reported, underscoring the need for surveillance and development of combination therapies.

4. What growth opportunities exist in endemic regions?
Mass drug administration programs, improved healthcare infrastructure, and increased awareness present opportunities to expand albendazole’s reach in Africa, Asia, and Latin America.

5. How might formulation innovations influence the future market?
Sustained-release and combination formulations could improve adherence, efficacy, and expand indications, ensuring prolonged market relevance for Albenza.


Sources:

[1] WHO. Weekly epidemiological record, 2020.
[2] Garcia, H. H., et al. (2014). Neurocysticercosis: Updated concepts about an underestimated disease.
[3] U.S. FDA. Albenza approval documents, 2001.
[4] WHO. Neglected Tropical Diseases Data, 2022.
[5] Market research reports, 2023.

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