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Last Updated: November 4, 2024

CLOFAZIMINE - Generic Drug Details


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

Clofazimine is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for clofazimine.

Summary for CLOFAZIMINE
Recent Clinical Trials for CLOFAZIMINE

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

SponsorPhase
National Medical Center for Infectious DiseasesPhase 3
Beijing Chest HospitalPhase 3
University of Cape TownPhase 2

See all CLOFAZIMINE clinical trials

Medical Subject Heading (MeSH) Categories for CLOFAZIMINE

US Patents and Regulatory Information for CLOFAZIMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis LAMPRENE clofazimine CAPSULE;ORAL 019500-002 Dec 15, 1986 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis LAMPRENE clofazimine CAPSULE;ORAL 019500-001 Dec 15, 1986 DISCN No 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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