Isoniazid; rifampin - Generic Drug Details

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

Isoniazid; rifampin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and Hikma Intl Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for isoniazid; rifampin

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	52
Patent Applications:	19
DailyMed Link:	isoniazid; rifampin at DailyMed

Recent Clinical Trials for isoniazid; rifampin

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

Sponsor	Phase
Tuberculosis Trials Consortium	Phase 2/Phase 3
First Affiliated Hospital of Zhejiang University	Phase 3
Miguel Santín	Phase 4

See all isoniazid; rifampin clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for isoniazid; rifampin

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

US Patents and Regulatory Information for isoniazid; rifampin

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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
Sanofi Aventis Us	RIFAMATE	isoniazid; rifampin	CAPSULE;ORAL	061884-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Intl Pharms	RIFAMPIN AND ISONIAZID	isoniazid; rifampin	CAPSULE;ORAL	065221-001	Jul 29, 2005		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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