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Last Updated: November 4, 2024

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

SponsorPhase
Health Clinics LimitedPhase 3
Kenya Medical Research InstitutePhase 2/Phase 3
Bahir Dar UniversityPhase 2/Phase 3

See all MEBENDAZOLE clinical trials

Pharmacology for MEBENDAZOLE
Drug ClassAnthelmintic
Medical Subject Heading (MeSH) Categories for MEBENDAZOLE

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 ⤷  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
Janssen Pharms VERMOX mebendazole TABLET, CHEWABLE;ORAL 017481-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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

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