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Last Updated: August 10, 2020

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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 Akorn, Barr, Lupin, and Sti Pharma Llc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for ethambutol hydrochloride. Nine suppliers are listed for this compound.

Recent Clinical Trials for ethambutol hydrochloride

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

SponsorPhase
Fifth Affiliated Hospital, Sun Yat-Sen UniversityN/A
Monash UniversityPhase 2/Phase 3
Cystic Fibrosis FoundationPhase 2/Phase 3

See all ethambutol hydrochloride clinical trials

Pharmacology for ethambutol hydrochloride
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
Lupin ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939-002 Jun 17, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Sti Pharma Llc MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 075095-002 Nov 30, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Harvard Business School
Express Scripts
Moodys
Colorcon

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