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Last Updated: November 27, 2022

Naftifine hydrochloride - Generic Drug Details


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What are the generic sources for naftifine hydrochloride and what is the scope of patent protection?

Naftifine hydrochloride is the generic ingredient in two branded drugs marketed by Taro Pharms, Tolmar, Xiromed, Sebela Ireland Ltd, and Taro, 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
Semler Research Center Pvt. Ltd.Phase 3
Genzum Life SciencesPhase 3
GenZum Life Sciences LLCPhase 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
Taro NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 208201-001 Apr 10, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-001 Feb 29, 1988 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xiromed NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 210038-001 Sep 22, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tolmar NAFTIFINE HYDROCHLORIDE naftifine hydrochloride GEL;TOPICAL 206165-001 Mar 20, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naftifine hydrochloride

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

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Merck
Medtronic
Mallinckrodt
Dow

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.