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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

NAFTIN Drug 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 four 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.

Summary for NAFTIN
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
GenZum Life Sciences LLCPhase 3
Semler Research Center Pvt. Ltd.Phase 3
Merz Pharmaceuticals, LLCPhase 4

See all NAFTIN clinical trials

Pharmacology for NAFTIN
Paragraph IV (Patent) Challenges for NAFTIN
Tradename Dosage Ingredient NDA Submissiondate
NAFTIN GEL;TOPICAL naftifine hydrochloride 204286 2015-02-04

US Patents and Regulatory Information for NAFTIN

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   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-002 Jan 13, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990   Start Trial   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 019356-001 Jun 18, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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