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Last Updated: November 4, 2024

ETHAMBUTOL HYDROCHLORIDE - Generic Drug Details


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

Ethambutol hydrochloride is the generic ingredient in two branded drugs marketed by Barr, Epic Pharma Llc, Lupin, and Kanchan Hlthcare, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ethambutol hydrochloride. Seven suppliers are listed for this compound.

Summary for ETHAMBUTOL HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 7
Raw Ingredient (Bulk) Api Vendors: 121
Clinical Trials: 118
Patent Applications: 6,760
What excipients (inactive ingredients) are in ETHAMBUTOL HYDROCHLORIDE?ETHAMBUTOL HYDROCHLORIDE excipients list
DailyMed Link:ETHAMBUTOL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for ETHAMBUTOL HYDROCHLORIDE

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

SponsorPhase
University College, LondonPhase 2
FindPhase 2
LMU University Hospital MunichPhase 2

See all ETHAMBUTOL HYDROCHLORIDE clinical trials

Pharmacology for ETHAMBUTOL HYDROCHLORIDE
Drug ClassAntimycobacterial
Medical Subject Heading (MeSH) Categories for ETHAMBUTOL HYDROCHLORIDE

US Patents and Regulatory Information for ETHAMBUTOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kanchan Hlthcare MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 076057-001 Nov 26, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939-002 Jun 17, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939-001 Jun 17, 2009 AB RX 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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