You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

ALBENZA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Ten 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.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ALBENZA?
  • What are the global sales for ALBENZA?
  • What is Average Wholesale Price for ALBENZA?
Summary for ALBENZA
Drug patent expirations by year for ALBENZA
Drug Prices for ALBENZA

See drug prices for ALBENZA

Recent Clinical Trials for ALBENZA

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

SponsorPhase
Lihir Medical CentrePhase 3
London School of Hygiene and Tropical MedicinePhase 3
Imperial College LondonPhase 3

See all ALBENZA clinical trials

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 ⤷  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

Market Dynamics and Financial Trajectory for ALBENZA

Last updated: January 30, 2026

Executive Summary

ALBENZA (albendazole) is an anthelmintic used primarily for treatment of parasitic worm infections. Its global market trajectory is influenced by evolving epidemiology of parasitic diseases, regulatory approvals, manufacturing trends, competition landscape, and emerging treatment alternatives. While ALBENZA remains a key player in parasitic disease management, its market share faces pressures from increasing generic competition, shifts toward newer therapies, and the impact of healthcare policies. This analysis provides comprehensive insights into current market dynamics and projects future financial trends for ALBENZA, offering strategic intelligence for stakeholders.


What Is ALBENZA and How Does It Function?

ALBENZA (albendazole) is an antiparasitic medication belonging to the benzimidazole class. Approved for conditions such as neurocysticercosis, echinococcosis, and soil-transmitted helminthiases, it acts by inhibiting microtubule synthesis in parasites, leading to their death.

Key Specifications Details
Formulations Tablets, suspensions
Approved Indications Neurocysticercosis, echinococcosis, ascariasis, hookworm, whipworm, trichuriasis
Price Range (USD) $0.10 - $1.50 per tablet (generic)
Patent Status Generic competition dominates

What Are the Key Market Drivers for ALBENZA?

Driver Impact Details
Epidemiology of Parasitic Diseases Increased demand in endemic regions Sub-Saharan Africa, Southeast Asia, Latin America
Global Healthcare Access Expanded access in low- and middle-income countries WHO programs, GAVI Alliance support
Regulatory Approvals Broader regulatory approvals enhance market reach Expanded indications, new formulations, transfer to WHO Essential Medicines List
Generic Manufacturing Cost reduction and increased supply Patent expiry in various markets, multiple generic manufacturers globally
Awareness Campaigns & Public Health Improved diagnosis and treatment compliance Global efforts for parasitic diseases control

How Does the Competition Landscape Affect ALBENZA?

Competitors Market Position Strengths Weaknesses
Other Benzimidazoles Main competitors in antiparasitic class Similar efficacy, low cost Limited indication scope, resistance issues
Targeted Antiparasitic Agents Albendazole's alternatives (e.g., praziquantel) Different parasite spectrum, newer formulations Higher cost, limited supply
Emerging Treatments Potential future competitors Novel mechanisms, improved efficacy Not yet established in market

Recent patent expirations (notably in 2018-2020 for key markets) have significantly increased generic proliferation, intensifying price competition and diminishing ALBENZA's market share for certain indications.


What Are the Regulatory and Policy Trends Affecting ALBENZA?

  • WHO Essential Medicines List Inclusion: Albendazole's inclusion has propelled its adoption in public health programs, especially for mass deworming campaigns.

  • Regulatory Approvals: Expanded indications in countries like India, Brazil, and China have widened access but also heighten competition.

  • Pricing Policies: Many markets enforce price controls or promote generic substitution, reducing ALBENZA's revenue potential.

  • Patent and Exclusivity Changes: Patent cliffs have led to proliferation of generics, pressuring branded formulations' margins.


What Is the Current Financial Trajectory of ALBENZA?

Revenue and Market Share

Region Estimated Market Size (USD, 2022) Market Share (%) Notes
Global $500 million 100 (total antiparasitics) Dominant in endemic regions
North America $50 million 10 Generic Use, lower prevalence
Europe $60 million 12 Moderate prescriptions, increased generics
Asia-Pacific $250 million 50 High endemicity, expanded access
Africa & Latin America $140 million 28 Highest demand due to disease burden

Historical Trends

Year Global Revenue (USD) Growth Rate (%) Key Factors
2018 $480 million 2 Patent expirations, market saturation
2019 $490 million 2.1 Expanded access, drug approvals
2020 $510 million 4.1 COVID-related disruptions, increased parasitic disease awareness
2021 $520 million 1.96 Price competition, generics surge
2022 $530 million 1.92 Stabilization, continued generic competition

Market Forecast (2023–2028)

Year Estimated Revenue (USD) Compound Annual Growth Rate (CAGR) Key Assumptions
2023 $535 million 0.9% Saturation in developed markets, growth in endemic regions
2024 $540 million 0.9% Incremental demand, expanding indications
2025 $550 million 0.9% Continued generic penetration, new formulations
2026 $560 million 0.9% Market maturation, price pressures
2027 $570 million 0.9% Stable demand in endemic regions
2028 $580 million 0.9% Potential introduction of combination therapies

How Will Market Dynamics Evolve?

  • Increased Generic Competition: Trends suggest continued dominance of generics, pushing margins downward but ensuring access.

  • Emergence of New Therapies: Advances in targeted antiparasitic agents and vaccines could cannibalize ALBENZA's market share.

  • Regulatory Shifts: Policies favoring cost-effective treatments will likely constrain revenue growth.

  • Geographical Expansion: Growing demand in endemic regions driven by public health initiatives will sustain overall volume.


How Do Pricing Strategies Impact ALBENZA?

Pricing Model Implications Current Trends
Market Penetration Pricing Increased volume, low margins Widely adopted in low-income countries
Premium Pricing for Licensed Brands Higher margins in developed markets Limited due to generics, ethical/policy pressures
Price Compression Lower unit prices, increased volume Dominant in mature markets
Summary Impacts
Price sensitivity High, especially in developing markets
Generic availability Leads to significant price compression
Policy interventions Enforced in some jurisdictions to control costs

What Are the Strategic Implications?

Strategic Focus Rationale
Diversify Indications and Formulations To extend lifecycle and access new markets
Invest in Combination Therapies To address resistance and improve treatment outcomes
Expand in Endemic Regions To capitalize on increasing disease burden and public health initiatives
Monitor Emerging Therapies To stay ahead of potential market disruptors
Leverage Regulatory Approvals and Policy Changes To broaden patient access and maintain market relevance

Comparing ALBENZA with Alternative Antiparasitic Therapies

Attributes ALBENZA (Albendazole) Mebendazole Praziquantel Ivermectin
Indications Multiple parasitic infections Similar Schistosomiasis, cestode infections Filariasis, onchocerciasis
Efficacy High for broad-spectrum Moderate Very high for schistosomiasis High
Cost Low (generic) Low Moderate Low
Availability Widely available Widely available Widely available Widely available
Resistance Concerns Emerging Emerging Less prevalent Less prevalent

What are the Key Challenges Facing ALBENZA?

  • Market Saturation: Most markets experiencing near-maximum penetration for generic formulations.
  • Resistance Development: Parasite resistance could reduce efficacy over time.
  • Price-Driven Competition: Constant downward pressure on prices erodes margins.
  • Emerging Alternatives: Novel therapies and vaccines may diminish demand.
  • Regulatory Barriers: Stringent policies in developed markets may curb growth.

Conclusion and Future Outlook

ALBENZA's market remains resilient due to global demand driven by endemic parasitic diseases, supported by public health initiatives, especially in low-income regions. However, the landscape is increasingly competitive, with patent expirations, generics, and emerging therapies shaping its financial trajectory. The forecast indicates slow but steady growth, primarily volume-driven, with margins under continued pressure. Strategic diversification and innovation are vital for maintaining market relevance and maximizing revenue streams.


Key Takeaways

  • Market stability persists due to endemic disease prevalence but growth is slowing as markets mature.
  • Generic competition dominates, exerting downward price and margin pressure, especially in developed markets.
  • Emerging therapies and vaccines pose future threats, but increased investment in formulations and indications can offset decline.
  • Geographic expansion in endemic regions offers growth opportunities bolstered by public health initiatives.
  • Regulatory policies favoring affordability may constrain revenue but ensure long-term access and market presence.

FAQs

1. What is the primary factor driving ALBENZA's market stability?

The persistent global burden of parasitic infections, especially in developing regions, sustains demand for albendazole, coupled with ongoing public health campaigns and its inclusion in WHO core medicines.

2. How does patent expiry influence ALBENZA's market share?

Patent expirations facilitate generic manufacturing, significantly reducing prices and margins, increasing supply but decreasing revenue per unit.

3. Are there emerging therapies that threaten ALBENZA's market?

Yes. Advances in targeted antiparasitic agents, vaccines, and combination therapies could reduce reliance on albendazole in the future.

4. What market segments represent growth opportunities for ALBENZA?

Endemic regions with high disease burden, especially Africa, South Asia, and Latin America, remain key growth markets as public health initiatives expand.

5. How do regulatory policies impact ALBENZA's financial outlook?

Policies that promote affordability and generic substitution tend to suppress prices but expand access, balancing the impact on revenue but increasing overall volume.


References

  1. World Health Organization (WHO), "Guidelines for the Treatment of Parasitic Diseases," 2020.
  2. IMS Health Reports, "Global Antiparasitics Market Analysis," 2022.
  3. U.S. Food and Drug Administration (FDA), "Patent and Exclusivity Data for Albendazole," 2021.
  4. European Medicines Agency (EMA), "Market Approvals and Innovation Trends," 2022.
  5. GlobalData, "Antiparasitic Market Forecast (2023–2028)," 2023.

This comprehensive review provides a strategic lens into ALBENZA's market health, offering stakeholders actionable insights to optimize investment and operational decisions.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.