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 Amneal, Taro, Xiromed, and Sebela Ireland Ltd, 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 seven drug master file entries for naftifine hydrochloride. Three suppliers are listed for this compound.

Summary for naftifine hydrochloride

International Patents:	3
US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	9
Patent Applications:	908
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

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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
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xiromed	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	210038-001	Sep 22, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 naftifine hydrochloride

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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	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Sign Up	⤷ Sign Up
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for naftifine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Australia	2014212201		⤷ Sign Up
Canada	2899725	COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME)	⤷ Sign Up
Canada	2899725		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014121048		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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