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Naftifine hydrochloride - Generic Drug Details

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What are the generic sources for naftifine hydrochloride and what is the scope of freedom to operate?

Naftifine hydrochloride is the generic ingredient in two branded drugs marketed by Taro Pharms, Tolmar, Xiromed, Sebela Ireland Ltd, and Taro, and is included in nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naftifine hydrochloride has three patent family members in three countries.

There are eight drug master file entries for naftifine hydrochloride. Four suppliers are listed for this compound.

Summary for naftifine hydrochloride

International Patents:	3
US Patents:	6
Tradenames:	2
Applicants:	5
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	9
Patent Applications:	565
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naftifine hydrochloride
What excipients (inactive ingredients) are in naftifine hydrochloride?	naftifine hydrochloride excipients list
DailyMed Link:	naftifine hydrochloride at DailyMed

Recent Clinical Trials for naftifine hydrochloride

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

Sponsor	Phase
Semler Research Center Pvt. Ltd.	Phase 3
GenZum Life Sciences LLC	Phase 3
Merz Pharmaceuticals, LLC	Phase 4

See all naftifine hydrochloride clinical trials

Pharmacology for naftifine hydrochloride

Drug Class

Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for naftifine hydrochloride

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

Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NAFTIN	GEL;TOPICAL	naftifine hydrochloride	204286	2015-02-04

US Patents and Regulatory Information for naftifine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	GEL;TOPICAL	206165-001	Mar 20, 2019	AB	RX	No	No
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	AB	RX	Yes	Yes
Taro Pharms	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	205975-001	Sep 8, 2016		RX	No	Yes
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes			Y
Xiromed	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	210038-001	Sep 22, 2020	AB	RX	No	No
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes

Expired US Patents for naftifine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990

International Patents for naftifine hydrochloride

Country	Patent Number	Estimated Expiration
Australia	2014212201
World Intellectual Property Organization (WIPO)	2014121048
Canada	2899725