NAFTIN Drug Patent Profile

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Which patents cover Naftin, and what generic alternatives are available?

Naftin is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naftin

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

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Summary for NAFTIN

International Patents:	3
US Patents:	6
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	8
Patent Applications:	668
Drug Prices:	Drug price information for NAFTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAFTIN
What excipients (inactive ingredients) are in NAFTIN?	NAFTIN excipients list
DailyMed Link:	NAFTIN at DailyMed

Drug patent expirations by year for NAFTIN

Recent Clinical Trials for NAFTIN

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

Sponsor	Phase
Therapeutics, Inc.	Phase 1
GenZum Life Sciences LLC	Phase 3
Semler Research Center Pvt. Ltd.	Phase 3

See all NAFTIN clinical trials

Pharmacology for NAFTIN

Drug Class	Allylamine Antifungal

Paragraph IV (Patent) Challenges for NAFTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	2015-02-04

US Patents and Regulatory Information for NAFTIN

NAFTIN is protected by six US patents.

Patents protecting NAFTIN

Topical compositions and methods for making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Topical compositions and methods for making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF FUNGAL INFECTIONS

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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	CREAM;TOPICAL	019599-001	Feb 29, 1988		DISCN	Yes	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	204286-001	Jun 27, 2013	AB	RX	Yes	Yes	⤷ 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
>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 NAFTIN

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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 NAFTIN

See the table below for patents covering NAFTIN around the world.

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Country	Patent Number	Title	Estimated Expiration
Switzerland	625202	Process for the preparation of novel N-(1-naphthylmethyl)-amines	⤷ Sign Up
Portugal	66475	PROCEDE POUR LA PREPARATION DE NOUVEAUX COMPOSES ORGANIQUES A EFFET PHARMACEUTIQUE	⤷ Sign Up
Switzerland	620896	Process for the preparation of novel N-(3-phenyl-2-propenyl)naphthylmethylamines	⤷ Sign Up
Australia	2014212201	Topical compositions and methods for making and using same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration