Last Updated: April 26, 2026

ALBENDAZOLE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Albendazole

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

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Summary for ALBENDAZOLE
US Patents:0
Applicants:9
NDAs:9

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Msn ALBENDAZOLE albendazole TABLET;ORAL 213435-001 Jan 21, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cipla Ltd ALBENDAZOLE albendazole TABLET;ORAL 210434-001 Sep 21, 2018 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

ALBENDAZOLE Market Analysis and Financial Projection

Last updated: February 5, 2026

What Is Albendazole?

Albendazole is an anthelmintic medication used to treat parasitic worm infections. It is widely prescribed for conditions such as neurocysticercosis, echinococcosis, and soil-transmitted helminthiasis. The drug is marketed globally under various brand names, including Zentel, Albenza, and Valbazen, among others. Its patent status varies by country, with many markets relying on generic versions.

Market Overview and Growth Drivers

The global albendazole market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years. Key drivers include:

  • High prevalence of parasitic infections, especially in developing countries with limited access to sanitation.
  • Increased awareness and screening for parasitic diseases.
  • Expanding indications for neurocysticercosis treatment.
  • Ongoing efforts by health organizations to control neglected tropical diseases (NTDs).

The World Health Organization (WHO) includes albendazole in its list of essential medicines, highlighting its importance in global health initiatives [1].

Patent and Regulatory Landscape

Most patents for albendazole expired in the early 2000s, leading to widespread generic manufacturing. Patent expirations in key markets include:

Country Patent Expiry Year Notes
United States 2000s Generics available since then
European Union Early 2000s Generics dominate
India Expired by 2005 Large generic production, low-cost options

Regulatory approvals are generally stable, with WHO prequalification enabling procurement by international agencies (e.g., UNICEF, PAHO).

Competitive Landscape and Market Share

The generic segment dominates, with major pharmaceutical companies producing albendazole API or finished formulations. Market share distribution is as follows:

  • Generic manufacturers: 70-80%
  • Branded drugs: 20-30% (primarily in developed markets)

Leading companies include:

  • Sun Pharma
  • Cipla
  • Mylan
  • GSK (historically, but shifted focus over time)

Brand vs. generic pricing varies dramatically across regions, influencing margins and investment returns.

R&D and Pipeline Status

Albendazole has limited ongoing R&D, with research primarily focusing on:

  • Formulation improvements to enhance bioavailability.
  • New combination therapies targeting multi-parasitic infections.
  • Alternative delivery methods (e.g., sustained-release formulations).

No major novel patent filings are active, reflecting the drug's status as a long-standing off-patent medication.

Investment Fundamentals

Revenue and Market Size

Global revenue estimates for albendazole exceed $200 million annually, with regional sales:

  • Asia-Pacific: largest market share (~50%) due to high parasitic disease burden.
  • Africa and Latin America: significant markets, often reliant on international aid programs.
  • Europe and North America: niche markets mainly for specific indications and branded formulations.

Cost Structure and Margins

Key factors include:

  • API production costs are low, often <$0.01 per tablet.
  • Manufacturing costs for finished formulations range between $0.02–$0.05 per dose.
  • Pricing varies from $0.05 in low-income countries to $2–$5 in wealthier markets.

Margins for generic manufacturers can be substantial if marketed efficiently, with profit margins exceeding 50% in some cases, considering low R&D expenditure and manufacturing costs.

Regulatory Risks and Opportunities

Regulatory hurdles are minimal post-patent expiry; however, quality compliance and registration in new markets require investments. Opportunities include:

  • Formulation innovations to differentiate products.
  • Expanded indications, especially for drug repurposing.
  • Strategic partnerships with global health organizations.

Supply Chain and Manufacturing Risks

Dependence on raw material suppliers for API and excipients can impact supply stability. Geopolitical factors, such as trade restrictions, could affect availability.

Investment Risks

Key risks involve:

  • Market saturation due to generic competition.
  • Pricing pressures in mature markets.
  • Limited pipeline, reducing growth potential beyond volume expansion.

Strategic Outlook

Investors should consider the following:

  • Focus on companies with global distribution channels targeting high-growth regions.
  • Monitor new formulation development that could command higher margins.
  • Assess potential for market expansion through inclusion in NTD elimination programs.

Key Takeaways

  • Albendazole is a mature, low-cost generic drug with a broad global market rooted in parasitic disease prevalence.
  • The patent cliff has facilitated widespread generic production, reducing prices but stabilizing large volumes.
  • The primary value driver is volume sales in emerging markets, supported by international health programs.
  • Near-term revenue growth is limited; focus shifts toward formulations, indications, and geographic expansion.
  • Supply chain stability and regulatory compliance remain critical for sustained profitability.

FAQs

1. What are the main therapeutic indications for albendazole?

Albendazole is primarily used to treat neurocysticercosis, echinococcosis, soil-transmitted helminthiasis, and other parasitic worm infections.

2. How competitive is the albendazole market?

It is highly competitive, dominated by generics with minimal differentiation other than price and supply reliability.

3. Are there any ongoing R&D efforts for albendazole?

Limited; most research focuses on formulation improvements and new combination therapies rather than novel drug development.

4. What are the licensing opportunities for new entrants?

Low due to the mature, off-patent status, but niche market expansion can occur through formulations or indications.

5. How significant are international health programs in driving albendazole sales?

Very significant; procurement by agencies like WHO and UNICEF supports steady demand, especially in low-income countries.


References

[1] World Health Organization, "Essential Medicines," accessed 2023.

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