Is there a generic for Rifabutin?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Rifabutin, referencing the brand MYCOBUTIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Rifabutin?

MYCOBUTIN (NDA 050689, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Rifabutin are approved?

Rifabutin is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Rifabutin

Rifabutin is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MYCOBUTIN · NDA 050689

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
MYCOBUTINRLD	PFIZER	NDA 050689	AB	Dec 23, 1992

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
RIFABUTIN	I3 PHARMS	ANDA 212430	AB	Mar 19, 2026
RIFABUTIN	NOVITIUM PHARMA	ANDA 215041	AB	Dec 17, 2021
RIFABUTIN	LUPIN	ANDA 090033	—	Feb 24, 2014

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Rifabutin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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