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Last Updated: September 19, 2020

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Which patents cover Naftifine Hydrochloride, and what generic alternatives are available?

Naftifine Hydrochloride is a drug marketed by Taro Pharms, Tolmar, and Taro. and is included in five NDAs.

The generic ingredient in NAFTIFINE HYDROCHLORIDE 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.

US ANDA Litigation and Generic Entry Outlook for Naftifine Hydrochloride

A generic version of NAFTIFINE HYDROCHLORIDE was approved as naftifine hydrochloride by TARO PHARMS on January 6th, 2016.

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Drug patent expirations by year for NAFTIFINE HYDROCHLORIDE
Recent Clinical Trials for NAFTIFINE HYDROCHLORIDE

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

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

See all NAFTIFINE HYDROCHLORIDE clinical trials

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 Pharms NAFTIFINE HYDROCHLORIDE naftifine hydrochloride CREAM;TOPICAL 205975-001 Sep 8, 2016 RX No Yes   Start Trial   Start Trial   Start Trial
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 206901-001 Jan 6, 2016 AB RX No 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

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Serving leading biopharmaceutical companies globally:

Express Scripts

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.