Viewing data from:

NAFTIN

NDA

NAFTIFINE HYDROCHLORIDE | N019599 | LEGACY PHARMA INC SEZC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis NCT01580891	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	1,053	2012-05 → 2013-07
Topical Gel Anti-Fungal Agent for Tinea Unguium NCT00253305	Phase 2	Completed	MediQuest Therapeutics	75	2005-09
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis NCT02132260	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	890	2013-08 → 2014-03
BE Study of Naftifine HCL NCT02633813	Phase 3	Completed	Genzum Life Sciences	693	2015-03 → 2015-12
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis NCT01712360	Phase 4	Completed	Merz North America, Inc.	56	2012-10 → 2013-11
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis NCT02335255	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	1,519	2014-06-27 → 2018-05-15
Safety and Efficacy of NAFT900 in Children With Tinea Capitis NCT02658292	Phase 2	Withdrawn	Merz North America, Inc.	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPANAFTIFINE HYDROCHLORIDE USP

DMF 147112000

NOVARTIS PHARMA AGNAFTIFINE HYDROCHLORIDE

DMF 167722003

OLON SPANAFTIFINE HYDROCHLORIDE

DMF 181472005

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 234562010

TARO PHARMACEUTICAL INDUSTRIES LTDNAFTIFINE HYDROCHLORIDE USP

DMF 246192012

CHONGQING HUAPONT PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 287352014

MSN LABORATORIES PRIVATE LTDNAFTIFINE HYDROCHLORIDE USP [ROUTE CODE "NT"]

DMF 289312015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 29, 1988

No patent or exclusivity listings for this strength.

#002 — 2%

RLDAB

0 patents0 exclusivities▾

CREAM;TOPICAL | Approved: Jan 13, 2012