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Last Updated: March 28, 2024

NAFTIFINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug 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. Four suppliers are listed for this compound.

Summary for NAFTIFINE HYDROCHLORIDE
Recent Clinical Trials for NAFTIFINE HYDROCHLORIDE

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

SponsorPhase
Genzum Life SciencesPhase 3
GenZum Life Sciences LLCPhase 3
Semler Research Center Pvt. Ltd.Phase 3

See all NAFTIFINE HYDROCHLORIDE clinical trials

Pharmacology for NAFTIFINE HYDROCHLORIDE
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
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-002 Jan 13, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 206901-001 Jan 6, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 205975-001 Sep 8, 2016 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-001 Feb 29, 1988 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 208201-001 Apr 10, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 206165-001 Mar 20, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 210038-001 Sep 22, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

International Patents for NAFTIFINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2014121048 ⤷  Try a Trial
Canada 2899725 COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME) ⤷  Try a Trial
Australia 2014212201 Topical compositions and methods for making and using same ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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