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Last Updated: August 12, 2020

DrugPatentWatch Database Preview

Naftifine hydrochloride - Generic Drug Details

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What are the generic 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 Taro Pharms, Tolmar, Sebela Ireland Ltd, and Taro, and is included in eight NDAs. There are four 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 eight drug master file entries for naftifine hydrochloride. Four suppliers are listed for this compound.

Summary for naftifine hydrochloride
International Patents:3
US Patents:4
Tradenames:2
Applicants:4
NDAs:8
Drug Master File Entries: 8
Suppliers / Packagers: 4
Bulk Api Vendors: 70
Clinical Trials: 9
Patent Applications: 524
DailyMed Link:naftifine hydrochloride at DailyMed
Recent Clinical Trials for naftifine hydrochloride

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

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

See all naftifine hydrochloride clinical trials

Pharmacology for naftifine hydrochloride
Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
NAFTIN GEL;TOPICAL naftifine hydrochloride 204286 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   Start Trial   Start Trial   Start Trial
Taro Pharms NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 205975-001 Sep 8, 2016 RX No Yes   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   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 019356-001 Jun 18, 1990 AB RX Yes Yes   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 CREAM;TOPICAL 019599-001 Feb 29, 1988 DISCN Yes No   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 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   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:

Express Scripts
McKesson
Medtronic
Colorcon
Johnson and Johnson
McKinsey

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