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Last Updated: August 10, 2022

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. Four suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.

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
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical compositions and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 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 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

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