Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204286

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NDA 204286 describes NAFTIN, which is a drug marketed by Sebela Ireland Ltd and is included in three NDAs. It is available from three suppliers. There are four 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. Five suppliers are listed for this compound. Additional details are available on the naftifine hydrochloride profile page.
Summary for 204286
Tradename:NAFTIN
Applicant:Sebela Ireland Ltd
Ingredient:naftifine hydrochloride
Patents:4
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
Paragraph IV (Patent) Challenges for 204286
Tradename Dosage Ingredient NDA Submissiondate
NAFTIN GEL;TOPICAL naftifine hydrochloride 204286 2015-02-04

Profile for product number 001

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

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