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Last Updated: November 7, 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

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SponsorPhase
Therapeutics, Inc.Phase 1
GenZum Life Sciences LLCPhase 3
Semler Research Center Pvt. Ltd.Phase 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
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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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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
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

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
Ireland 45727 ARALKENYLAMINOMETHYL-NAPHTHALENE DERIVATIVES ⤷  Sign Up
South Africa 7702564 ⤷  Sign Up
Belgium 853976 ⤷  Sign Up
Denmark 171577 ⤷  Sign Up
France 2349566 ⤷  Sign Up
Austria A293677 ⤷  Sign Up
Japan H0138766 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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