MEBENDAZOLE - Generic Drug Details

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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
Leiden University Medical Center	Phase 2/Phase 3
European and Developing Countries Clinical Trials Partnership (EDCTP)	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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	208398-001	Oct 19, 2016		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	EMVERM	mebendazole	TABLET, CHEWABLE;ORAL	073580-001	Jan 4, 1995		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for MEBENDAZOLE

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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