NAFTIFINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Naftifine Hydrochloride, and what generic alternatives are available?

Naftifine Hydrochloride is a drug marketed by Amneal, Taro, and Xiromed. and is included in six NDAs.

The generic ingredient in NAFTIFINE HYDROCHLORIDE is naftifine hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naftifine Hydrochloride

A generic version of NAFTIFINE HYDROCHLORIDE was approved as naftifine hydrochloride by TARO on January 6^th, 2016.

Summary for NAFTIFINE HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	9
Patent Applications:	738
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
GenZum Life Sciences LLC	Phase 3
Semler Research Center Pvt. Ltd.	Phase 3
Genzum Life Sciences	Phase 3

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	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	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
Amneal	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	206960-001	Apr 10, 2017	AB	RX	No	No
Xiromed	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	210038-001	Sep 22, 2020	AB	RX	No	No
Taro	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	205975-001	Sep 8, 2016		RX	No	Yes
Taro	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	206901-001	Jan 6, 2016	AB	RX	No	No
Taro	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	GEL;TOPICAL	208201-001	Apr 10, 2019	AB	RX	No	No
Amneal	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	GEL;TOPICAL	206165-001	Mar 20, 2019	AB	RX	No	No