Isoniazid - Generic Drug Details

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

Isoniazid is the generic ingredient in eleven branded drugs marketed by Sandoz, Roche, Chartwell Rx, Cmp Pharma Inc, Lannett, Dow Pharm, Medpointe Pharm Hlc, Novartis, Barr, Duramed Pharms Barr, Epic Pharma Llc, Halsey, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lilly, Mk Labs, Nexgen Pharma Inc, Omnivium Pharms, Panray, Perrigo, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Sun Pharm Industries, Thepharmanetwork Llc, Watson Labs, Whiteworth Town Plsn, Chartwell Molecular, Bristol Myers Squibb, Everylife, and Sanofi Aventis Us, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for isoniazid. Sixteen suppliers are listed for this compound.

Summary for isoniazid

US Patents:	0
Tradenames:	11
Applicants:	32
NDAs:	47
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	226
Patent Applications:	6,720
Drug Prices:	Drug price trends for isoniazid
What excipients (inactive ingredients) are in isoniazid?	isoniazid excipients list
DailyMed Link:	isoniazid at DailyMed

See drug prices for isoniazid

Recent Clinical Trials for isoniazid

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

Sponsor	Phase
Freundeskreis Für Internationale Tuberkulosehilfe e.V	Phase 3
Indian Council of Medical Research	Phase 3
Madras Medical College	Phase 3

See all isoniazid clinical trials

Pharmacology for isoniazid

Drug Class	Antimycobacterial

Medical Subject Heading (MeSH) Categories for isoniazid

Antitubercular Agents
Fatty Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for isoniazid

J04AC	Hydrazides
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for isoniazid

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Phoenix Labs Ny	ISONIAZID	isoniazid	TABLET;ORAL	080368-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	RIFATER	isoniazid; pyrazinamide; rifampin	TABLET;ORAL	050705-001	May 31, 1994		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	ISONIAZID	isoniazid	TABLET;ORAL	080521-001	Approved Prior to Jan 1, 1982		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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