Ethambutol hydrochloride - Generic Drug Details

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 Sti Pharma Llc, 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. Eight 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:	8
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	112
Patent Applications:	6,793
Formulation / Manufacturing:	see details
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

Sponsor	Phase
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic	Phase 2
Tuberculosis Trials Consortium	Phase 2/Phase 3
University of Stellenbosch	Phase 2

See all ethambutol hydrochloride clinical trials

Pharmacology for ethambutol hydrochloride

Drug Class

Antimycobacterial

Medical Subject Heading (MeSH) Categories for ethambutol hydrochloride

Antitubercular Agents

Anatomical Therapeutic Chemical (ATC) Classes for ethambutol hydrochloride

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

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
Barr	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	076057-001	Nov 26, 2001		DISCN	No	No
Epic Pharma Llc	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	075095-002	Nov 30, 1999	AB	RX	No	No
Sti Pharma Llc	MYAMBUTOL	ethambutol hydrochloride	TABLET;ORAL	016320-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Lupin	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	078939-001	Jun 17, 2009	AB	RX	No	No
Sti Pharma Llc	MYAMBUTOL	ethambutol hydrochloride	TABLET;ORAL	016320-002	Approved Prior to Jan 1, 1982		DISCN	No	No