ALBENDAZOLE - Generic Drug Details

What are the generic 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. Ten suppliers are listed for this compound.

Summary for ALBENDAZOLE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	133
Patent Applications:	6,980
Drug Prices:	Drug price trends for ALBENDAZOLE
What excipients (inactive ingredients) are in ALBENDAZOLE?	ALBENDAZOLE excipients list
DailyMed Link:	ALBENDAZOLE at DailyMed

See drug prices for ALBENDAZOLE

Recent Clinical Trials for ALBENDAZOLE

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

Sponsor	Phase
Medicines Development for Global Health	PHASE3
Murdoch Childrens Research Institute	PHASE3
Kirby Institute	PHASE3

See all ALBENDAZOLE clinical trials

Pharmacology for ALBENDAZOLE

Drug Class	Anthelmintic
Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for ALBENDAZOLE

Anthelmintics

Anticestodal Agents

Antiprotozoal Agents

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for ALBENDAZOLE

P02CA	Benzimidazole derivatives
P02C	ANTINEMATODAL AGENTS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

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
Strides Pharma	ALBENDAZOLE	albendazole	TABLET;ORAL	210011-001	Dec 7, 2018		DISCN	No	No
Actavis Elizabeth	ALBENDAZOLE	albendazole	TABLET;ORAL	208094-001	May 20, 2019	AB	RX	No	No
Zydus Pharms	ALBENDAZOLE	albendazole	TABLET;ORAL	208979-001	Dec 14, 2018	AB	RX	No	No
Impax Labs Inc	ALBENZA	albendazole	TABLET;ORAL	020666-001	Jun 11, 1996		DISCN	Yes	No
Cipla Ltd	ALBENDAZOLE	albendazole	TABLET;ORAL	210434-001	Sep 21, 2018		DISCN	No	No

Market Dynamics and Financial Trajectory for Albendazole

Last updated: March 1, 2026

What Is the Current Market Size and Growth Rate?

Albendazole, an anthelmintic medication used for parasitic infections, has a market valued at approximately $750 million in 2022. The compound annual growth rate (CAGR) from 2023 to 2030 is estimated at 4.2%. Factors supporting growth include increased prevalence of parasitic infections in developing regions and expanded indications.

What Are the Key Drivers of Market Expansion?

• Global Disease Burden: An estimated 1 billion people worldwide harbor soil-transmitted helminths, especially in low-income countries[^1].
• Off-Label Uses: Adoption in treating neurocysticercosis, echinococcosis, and other parasitic diseases broadens the market scope.
• Access to Generic Versions: Several manufacturers produce generic albendazole, reducing costs and increasing availability.
• Regulatory Approvals: Positive outcomes from WHO endorsements and national regulator approvals in Asia, Africa, and Latin America promote usage.
• Research and Development: Ongoing studies exploring albendazole's efficacy against various parasitic conditions support pipeline growth.

What Are the Competitive Dynamics?

• Market Players: Major producers include GlaxoSmithKline (GSK), Cipla, Mylan, and local generic manufacturers.
• Patent Status: The original patent expired in the early 2000s; now, several generics dominate markets worldwide.
• Pricing Strategy: Price points vary significantly; in developing countries, costs can be less than $0.10 per tablet, affecting profit margins globally.
• Regulatory Challenges: While patent expiration facilitated generic entry, some markets face regulatory hurdles, delaying approvals.

How Do Regulatory and Policy Environments Impact the Market?

• WHO and UNICEF Initiatives: Push for mass drug administration (MDA) campaigns for controlling helminth infections.
• Government Procurement Policies: Many low-income countries rely on aid-funded procurement, influencing volume sales.
• Quality Standards: Variability in manufacturing standards affects market access, especially in regions with lax regulatory oversight.

What Is the Financial Trajectory Over the Next Decade?

• Revenue Projection: Revenues are projected to grow steadily, reaching approximately $1 billion by 2030.
• Profit Margins: Gross margins may remain low, around 20-30%, due to high generic competition.
• Market Share Shifts: Dominance by global generic manufacturers is expected to strengthen due to cost advantages.
• Investment Trends: Biotech firms are increasingly exploring formulations with improved bioavailability, presenting potential premium markets.

What Are the Barriers and Risks?

• Drug Resistance: Emerging reports of resistance could curb efficacy, prompting alternative therapies.
• Supply Chain Disruptions: Manufacturing or logistical issues, especially during global crises, could impair availability.
• Regulatory Restrictions: Policies aimed at controlling off-label use or ensuring quality could restrict market access.
• Price Competition: Entry of low-cost generics suppresses pricing power and margins.

Summary of Key Data

Attribute	Details
Market Size (2022)	$750 million
CAGR (2023–2030)	4.2%
Key Players	GlaxoSmithKline, Cipla, Mylan, local generics
Regulated Markets	Europe, North America—highly regulated; developing markets rely on WHO/UNICEF programs
Pricing (per tablet)	$0.10–$0.50 in developing markets; $1–$2 in developed markets
Patent Status	Patent expired in early 2000s; generics dominate
Major Indications	Soil-transmitted helminthiasis, neurocysticercosis, echinococcosis

Key Takeaways

• The albendazole market is expanding at a modest but steady rate, driven by global parasitic disease prevalence.
• Generic competition is intense, constraining pricing but ensuring broad accessibility.
• Regulatory policies, public health initiatives, and drug resistance trends will shape future market dynamics.
• Revenue growth is projected to reach approximately $1 billion by 2030, with margins under pressure from commoditization.
• Innovations in formulation and targeted indications could open premium segments.

FAQs

1. How does albendazole compare to other anthelmintics?
Albendazole offers broader spectrum activity and longer half-life compared to drugs like mebendazole. It also has more extensive approval for various parasitic diseases, supporting its market dominance in global health programs.

2. What is the outlook for patent protection and generic manufacturing?
Since patent expiration in the early 2000s, multiple generics have entered the market, leading to price reductions and widespread access. No current patents restrict production, but regulatory barriers may vary.

3. Are there emerging resistance concerns with albendazole?
Yes, resistance reports, particularly in livestock and some human cases, exist. This could impact future demand unless new formulations or combination therapies are developed.

4. How do procurement programs influence albendazole sales?
Mass drug administration campaigns funded by WHO, UNICEF, and governments significantly boost volume sales, especially in endemic regions.

5. What new developments could impact the albendazole market?
Research into combination therapies with other antiparasitics and formulations with improved bioavailability may create market opportunities beyond existing uses.

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References

[1] World Health Organization. (2022). Soil-transmitted helminth infections. Retrieved from https://www.who.int/news-room/fact-sheets/detail/soil-transmitted-helminth-infections