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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 204286


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NDA 204286 describes NAFTIN, which is a drug marketed by Legacy Pharma and is included in three NDAs. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAFTIN profile page.

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 204286
Tradename:NAFTIN
Applicant:Legacy Pharma
Ingredient:naftifine hydrochloride
Patents:6
Pharmacology for NDA: 204286
Suppliers and Packaging for NDA: 204286
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAFTIN naftifine hydrochloride GEL;TOPICAL 204286 NDA Sebela Pharmaceuticals Inc. 54766-772 54766-772-45 1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE
NAFTIN naftifine hydrochloride GEL;TOPICAL 204286 NDA Sebela Pharmaceuticals Inc. 54766-772 54766-772-60 1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2%
Approval Date:Jun 27, 2013TE:ABRLD:Yes
Patent:⤷  Get Started FreePatent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Get Started FreePatent Expiration:Jan 31, 2033Product Flag?YSubstance Flag?Delist Request?

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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