Is there a generic for Butenafine hydrochloride?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Butenafine hydrochloride, referencing the brand LOTRIMIN ULTRA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Butenafine hydrochloride?

LOTRIMIN ULTRA (NDA 021307, BAYER HEALTHCARE LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Butenafine hydrochloride are approved?

Butenafine hydrochloride is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Butenafine hydrochloride

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

Reference-listed drug:LOTRIMIN ULTRA · NDA 021307

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
LOTRIMIN ULTRARLD	BAYER HEALTHCARE LLC	NDA 021307	—	Dec 07, 2001
MENTAXRLD	PHARMOBEDIENT	NDA 020524	—	Oct 18, 1996
MENTAX-TC	PHARMOBEDIENT	NDA 021408	—	Oct 17, 2002

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
BUTENAFINE HYDROCHLORIDE	SUN PHARMA CANADA	ANDA 205181	—	Nov 16, 2017

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.

Butenafine hydrochloride — frequently asked questions

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

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