Mebendazole - Generic Drug Details

What are the generic sources for mebendazole and what is the scope of patent protection?

Mebendazole is the generic ingredient in two branded drugs marketed by Impax Labs Inc and Janssen Pharms, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for mebendazole. One supplier is listed for this compound.

Summary for mebendazole

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	36
What excipients (inactive ingredients) are in mebendazole?	mebendazole excipients list
DailyMed Link:	mebendazole at DailyMed

Recent Clinical Trials for mebendazole

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

Sponsor	Phase
University of the Philippines	PHASE3
Swiss Tropical & Public Health Institute	PHASE3
Bayer	PHASE3

See all mebendazole clinical trials

Pharmacology for mebendazole

Drug Class

Anthelmintic

Medical Subject Heading (MeSH) Categories for mebendazole

Antinematodal Agents

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for mebendazole

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

US Patents and Regulatory Information for mebendazole

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	EMVERM	mebendazole	TABLET, CHEWABLE;ORAL	073580-001	Jan 4, 1995		RX	No	Yes
Janssen Pharms	VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	017481-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	208398-001	Oct 19, 2016		DISCN	Yes	No

Expired US Patents for mebendazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	017481-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Mebendazole

Last updated: February 12, 2026

Mebendazole is a broad-spectrum anthelminthic used primarily for treating parasitic worm infections including roundworms, whipworms, hookworms, and pinworms. Its market presence is influenced by clinical efficacy, regulatory status, patent landscape, generic competition, and global disease burden.

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What Is the Current Market Size for Mebendazole?

The global anthelminthic drugs market was valued at approximately USD 620 million in 2021. Mebendazole accounts for a significant share, driven by:

• High prevalence of parasitic infections in developing countries.
• Inclusion in WHO’s essential medicines list.

• Broad licensing for off-patent status.

  While precise sales figures per product are proprietary, estimates suggest annual global sales of mebendazole hover between USD 80 and USD 120 million. The market's geographic distribution favors regions like Southeast Asia, Africa, and Latin America, where parasitic infections remain high.

How Does Mebendazole’s Patent and Regulatory Status Impact Its Market?

Mebendazole's patent protection expired in the early 2000s, leading to widespread generic manufacturing. This patent expiry resulted in:

• Price decline: Generic versions are priced 50-70% lower than the branded formulations.
• Market penetration increase: Higher affordability in low-income regions enhances access.
• Limited R&D incentives: No new clinical formulations or derivatives have been pursued historically, given low profit margins.

Regulatory approvals in most jurisdictions are straightforward owing to its long-standing use and established safety profile. No major regulatory blockage currently hampers market access.

What Is the Impact of Competition on Financial Performance?

The market features multiple generic manufacturers, with key players like:

• Teva Pharmaceuticals
• Ranbaxy (now part of Sun Pharma)
• Mylan

These companies dominate regional markets. As patent barriers disappear, the price erosion accelerates. Revenue growth for mebendazole products tends to be stagnant or declining in mature markets due to:

• Saturation of existing markets.
• Competition from alternative formulations like albendazole and praziquantel.

In contrast, emerging markets continue to offer revenue opportunities due to high disease prevalence, though margins are lower.

What Are the Future Market Drivers and Challenges?

Drivers:

• Ongoing public health campaigns targeting parasitic infections.
• WHO initiatives promoting mass drug administration (MDA) programs.
• Potential development of fixed-dose combination therapies for comprehensive parasitic treatment.

Challenges:

• Lack of patent protection diminishes incentives for innovation.
• Competition from newer molecules with broader antiparasitic spectra.
• Limited market growth in developed countries due to low disease prevalence and switch to alternative medicines.

How Will Global Disease Burden Affect Market Expansion?

The World Health Organization estimates over 1 billion people are affected annually by parasitic worms, mainly in low-resource countries. Mebendazole remains a core treatment in mass drug administration programs, underpinning consistent demand in these regions. Public health initiatives lead to predictable procurement but do not significantly elevate profit margins due to government procurement standards and price controls.

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Summary of Financial Trajectory:

Aspect	Details
Market Size (2021)	USD 620 million (total anthelminthic market); Mebendazole's share USD 80-120 million
Revenue Trends	Stabilization or decline in mature markets; growth potential in emerging markets
Patent Status	Expired, leading to generic competition
Pricing Dynamics	Price erosion driven by generics; low margins in most regions
Regulatory Environment	Favorable; approved globally with minimal barriers
Competitive Landscape	Fragmented; dominated by generic manufacturers

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Key Takeaways

• Mebendazole's market is mature with limited growth potential in developed regions.
• Revenue primarily comes from low-income countries with high parasitic disease burden.
• Patent expiry and generic competition have driven prices down, constraining profit margins.
• Public health programs sustain steady demand but do not foster significant innovation or pricing power.
• Market expansion depends on the persistence of parasitic infections and global health initiatives.

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Frequently Asked Questions

1. What is the primary driver of mebendazole sales globally?
   Parasite infection prevalence in low-income, high-burden countries supports steady demand, especially through mass drug administration programs.

2. Are there any new formulations or derivatives of mebendazole under development?
   No significant clinical development or reformulations are publicly reported; focus remains on generic supply.

3. How does competition affect mebendazole's pricing and profitability?
   Widespread generic production peaks prices below USD 0.10 per dose, limiting revenue and profitability for manufacturers.

4. What is the potential impact of emerging markets on future sales?
   Higher disease prevalence offers growth opportunities, but price sensitivity and limited healthcare infrastructure keep margins low.

5. Could legislative or policy changes influence mebendazole’s market?
   Increased focus on parasitic disease control could sustain or slightly expand the market but unlikely to significantly alter revenue trends due to limited innovations.

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References

1. Statista. "Global Anthelminthic Drugs Market Size." 2022.
2. World Health Organization. "Guidelines for the treatment of parasitic infections." 2019.
3. Grand View Research. "Anthelmintic Drugs Market Size, Share & Trends." 2022.
4. EvaluatePharma. "Generic Drug Market Trends." 2022.
5. U.S. Food and Drug Administration. "Official approval records for Mebendazole." 2000.

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