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Last Updated: November 21, 2024

naftin Drug Patent Profile


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When do Naftin patents expire, and when can generic versions of Naftin launch?

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 6th, 2016.

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Drug patent expirations by year for naftin
Drug Prices for naftin

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Recent Clinical Trials for naftin

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

SponsorPhase
Therapeutics, Inc.Phase 1
Semler Research Center Pvt. Ltd.Phase 3
Genzum Life SciencesPhase 3

See all naftin clinical trials

Pharmacology for naftin
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
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Patent Expiration: ⤷  Sign Up

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

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

Topical compositions and methods for making and using same
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Topical compositions and methods for making and using same
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Patented Use: TREATMENT OF FUNGAL INFECTIONS

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
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-002 Jan 13, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 naftin

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.

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
Sweden 440772 FORFARANDE FOR FRAMSTELLNING AV NYA 1-NAFTYLMETYL-CINNAMYL-AMINDERIVAT ⤷  Sign Up
Australia 513249 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.