Rifabutin - Generic Drug Details

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What are the generic drug sources for rifabutin and what is the scope of freedom to operate?

Rifabutin is the generic ingredient in two branded drugs marketed by Pfizer, Lupin Ltd, and Novitium Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for rifabutin. Four suppliers are listed for this compound.

Summary for rifabutin

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	90
Patent Applications:	2
Drug Prices:	Drug price trends for rifabutin
What excipients (inactive ingredients) are in rifabutin?	rifabutin excipients list
DailyMed Link:	rifabutin at DailyMed

See drug prices for rifabutin

Recent Clinical Trials for rifabutin

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

Sponsor	Phase
CW-Research and Management GmbH	Phase 1
Tuberculosis Trials Consortium	Phase 2/Phase 3
Gilead Sciences	Phase 1

See all rifabutin clinical trials

Pharmacology for rifabutin

Drug Class	Rifamycin Antimycobacterial

Medical Subject Heading (MeSH) Categories for rifabutin

Anti-Bacterial Agents
Antibiotics, Antitubercular

Anatomical Therapeutic Chemical (ATC) Classes for rifabutin

J04AB	Antibiotics
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for rifabutin

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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
Lupin Ltd	RIFABUTIN	rifabutin	CAPSULE;ORAL	090033-001	Feb 24, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	RIFABUTIN	rifabutin	CAPSULE;ORAL	215041-001	Dec 17, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	MYCOBUTIN	rifabutin	CAPSULE;ORAL	050689-001	Dec 23, 1992	AB	RX	Yes	Yes	⤷ 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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