MEBENDAZOLE - Generic Drug Details

What are the generic drug sources for mebendazole and what is the scope of freedom to operate?

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. Two suppliers are 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:	2
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	29
Patent Applications:	5,894
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
Health Clinics Limited	Phase 3
Bahir Dar University	Phase 2/Phase 3
Barcelona Institute for Global Health	Phase 2/Phase 3

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
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
Impax Labs Inc	EMVERM	mebendazole	TABLET, CHEWABLE;ORAL	073580-001	Jan 4, 1995		RX	No	Yes

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

MEBENDAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mebendazole

Introduction

Mebendazole, an anthelmintic drug, is crucial in the treatment of parasitic infections, particularly intestinal worms or soil-transmitted helminths (STH). The market for mebendazole is driven by several key factors, including the high prevalence of helminth infections, global health initiatives, and advancements in drug formulation.

Market Size and Growth Projections

The mebendazole market has been valued at different levels by various reports, but all indicate significant growth.

• As of 2023, the global mebendazole market was valued at approximately $117.6 million and is expected to reach $173 million by 2030, growing at a CAGR of 5.6% during the forecast period of 2024-2030[1].
• Another report estimates the market size to be $231.8 million in 2023, projected to grow to $470.2 million by 2031, with a CAGR of 8.2% from 2024 to 2031[3].

Drivers of Market Growth

High Prevalence of Helminth Infections

Helminth infections are widespread in tropical and subtropical regions, particularly in areas with poor sanitation, inadequate hygiene, and limited access to clean water and healthcare services. This high burden drives the demand for effective anthelmintic treatments like mebendazole[4].

Global Deworming Initiatives

The inclusion of mebendazole in global deworming initiatives and mass drug administration programs significantly contributes to market growth. Organizations such as the World Health Organization (WHO) and various non-governmental organizations (NGOs) prioritize the distribution of mebendazole to combat neglected tropical diseases (NTDs)[2][4].

Technological Advancements in Drug Formulation

Advancements in drug formulation, such as the development of easier-to-swallow formulations for children, enhance the effectiveness and convenience of mebendazole. This innovation attracts more customers and drives market expansion[2][4].

Government Initiatives and Public Health Programs

Government initiatives and public health programs that encourage deworming in communities and schools significantly increase market demand. These programs highlight the importance of treating parasitic infections and improve access to healthcare services in emerging nations[3][4].

Increasing Healthcare Spending

Growing healthcare spending and expanding access to healthcare services in emerging economies fuel the growth of the mebendazole market. As healthcare infrastructure improves, the demand for efficient anthelmintic drugs increases[3].

Key Players and Donation Programs

Johnson & Johnson's Donation Program

Johnson & Johnson has a long-standing commitment to eliminating intestinal worms through its donation program. The company has extended its commitment through 2025, ensuring the delivery of one billion doses of VERMOX® CHEWABLE (mebendazole) to high-burden countries via the WHO. This program is a significant contributor to the global effort against NTDs[2].

Regulatory and Quality Control Measures

The production and distribution of mebendazole are governed by stringent regulatory requirements and quality control measures. These regulations ensure the safety and efficacy of the drug but also present challenges for manufacturers in terms of compliance and cost[4].

Socioeconomic Impact

Health Implications

Helminth infections have a damaging impact on the health and development of children, leading to malnutrition, impaired cognitive development, and reduced ability to learn and grow. Effective treatment with mebendazole is crucial in mitigating these effects[2].

Economic and Social Impacts

Neglected tropical diseases, including helminth infections, impose significant socioeconomic costs. These include reduced economic productivity, lower physical endurance, increased dropout rates from school, and potential security issues due to large-scale migration and conflicts[5].

Future Outlook

The mebendazole market is expected to experience sustained growth driven by the ongoing global burden of helminth infections and increasing emphasis on public health initiatives. As awareness of the socioeconomic impact of these infections rises, there will be a greater demand for effective and affordable anthelmintic treatments like mebendazole. The expansion of healthcare services and improved access to pharmaceutical products in underserved regions will further contribute to market growth[4].

Challenges in Drug Development

Despite the growing demand, the development of drugs for neglected infectious diseases faces significant challenges, including high developmental risks, low return on investment, and stringent regulatory requirements. Mechanisms such as public-private partnerships, new funding mechanisms, and innovative R&D approaches are necessary to address these challenges[5].

Key Takeaways

• The mebendazole market is projected to grow significantly, driven by high prevalence of helminth infections and global health initiatives.
• Technological advancements in drug formulation and government initiatives are key drivers of market growth.
• Johnson & Johnson's donation program is a significant contributor to the global effort against NTDs.
• The market faces challenges such as stringent regulatory requirements and high developmental risks.
• The socioeconomic impact of helminth infections underscores the importance of effective treatment options like mebendazole.

FAQs

What is the current market size of mebendazole and its projected growth?

The mebendazole market was valued at $117.6 million in 2023 and is expected to reach $173 million by 2030, growing at a CAGR of 5.6% during the forecast period of 2024-2030[1].

What are the main drivers of the mebendazole market?

The main drivers include the high prevalence of helminth infections, global deworming initiatives, technological advancements in drug formulation, government initiatives, and increasing healthcare spending[3][4].

Which company has a significant donation program for mebendazole?

Johnson & Johnson has a long-standing donation program for mebendazole, extending its commitment through 2025 to deliver one billion doses of VERMOX® CHEWABLE to high-burden countries[2].

What are the socioeconomic impacts of helminth infections?

Helminth infections have significant socioeconomic impacts, including health implications such as malnutrition and impaired cognitive development, economic impacts such as reduced productivity, and social impacts such as increased dropout rates and potential security issues[5].

What challenges does the development of mebendazole face?

The development of mebendazole faces challenges such as high developmental risks, low return on investment, and stringent regulatory requirements. Addressing these challenges requires innovative R&D approaches and public-private partnerships[5].

Sources

1. Global Mebendazole Market Research Report 2024 - Valuates Reports
2. Johnson & Johnson Extends Long-Standing Donation Program to Support Global Effort to Tackle Intestinal Worms - Johnson & Johnson
3. Mebendazole Market Size and Projections - Market Research Intellect
4. Mebendazole Market Size, Share & Forecast 2033 - Data Horizon Research
5. The Development Dimension: Coherence for Health - OECD