Last Updated: September 24, 2026

Butenafine hydrochloride - Generic Drug Details

Name: butenafine hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Butenafine hydrochloride is the generic ingredient in four branded drugs marketed by Sun Pharma Canada, Bayer Healthcare Llc, and Pharmobedient, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for butenafine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	4
Patent Applications:	594
What excipients (inactive ingredients) are in butenafine hydrochloride?	butenafine hydrochloride excipients list
DailyMed Link:	butenafine hydrochloride at DailyMed

Recent Clinical Trials for butenafine hydrochloride

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

Sponsor	Phase
United Laboratories	Phase 2
Taro Pharmaceuticals USA	Phase 1

See all butenafine hydrochloride clinical trials

Pharmacology for butenafine hydrochloride

Drug Class	Benzylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for butenafine hydrochloride

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for butenafine hydrochloride

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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
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307-001	Dec 7, 2001		OTC	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmobedient	MENTAX-TC	butenafine hydrochloride	CREAM;TOPICAL	021408-001	Oct 17, 2002		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmobedient	MENTAX	butenafine hydrochloride	CREAM;TOPICAL	020524-001	Oct 18, 1996		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for butenafine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	MENTAX	butenafine hydrochloride	CREAM;TOPICAL	020524-001	Oct 18, 1996	5,021,458	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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