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LAMISIL

NDA

TERBINAFINE HYDROCHLORIDE | N022071 | NOVARTIS PHARMACEUTICALS CORP

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2021-P-1180 · 6 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Terbinafine Tablets, USP 125 mg, suitable for submission as an Abbrev	Suitability	2021-11-01	Withdrawn	HYMAN, PHELPS & MCNAMARA, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

30 trials from ClinicalTrials.gov, 25 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis NCT00459537	Phase 3	Completed	Novartis	1,029	2007-03 → 2009-01
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions NCT00833664	Phase 1	Completed	Teva Pharmaceuticals USA	22	2002-01 → 2002-01
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions NCT00602342	N/A	Completed	Roxane Laboratories	30	2004-03 → 2004-04
Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail NCT01484145	Phase 2	Completed	Nitric BioTherapeutics, Inc	25	2011-12 → 2012-04
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)NCT00491764	Phase 2	Completed	Merck Sharp & Dohme LLC	218	2007-06 → 2008-12
Topical Gel Anti-Fungal Agent for Tinea Unguium NCT00253305	Phase 2	Completed	MediQuest Therapeutics	75	2005-09
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg NCT00647647	Phase 1	Completed	Mylan Pharmaceuticals Inc	36	2004-02 → 2004-03
Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis NCT00691184	Phase 1	Completed	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)	56	2005-02 → 2005-12
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions NCT01286688	Phase 1	Completed	Dr. Reddy's Laboratories Limited	36	2002-01 → 2002-03
Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis NCT01080079	Phase 2	Completed	Nitric BioTherapeutics, Inc	168	2010-05 → 2012-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain21 active DMFs6 inactive

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

DR REDDYS LABORATORIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 158872002

HOLIDAY LABS MEXICO SA DE CVTERBINAFINE HYDROCHLORIDE

DMF 161872002

AMINO CHEMICALS LTDTERBINAFINE HYDROCHLORIDE

DMF 162832002

GEDEON RICHTER PLCTERBINAFINE HYDROCHLORIDE USP

DMF 165112003

CIPLA LTDTERBINAFINE HYDROCHLORIDE USP

DMF 173302004

TARO PHARMACEUTICAL INDUSTRIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 177902004

QUIMICA SINTETICA SATERBINAFINE HYDROCHLORIDE

DMF 179142004

HETERO LABS LTDTERBINAFINE HYDROCHLORIDE

DMF 179872005

ALIVUS LIFE SCIENCES LTDTERBINAFINE HYDROCHLORIDE, USP

DMF 181752005

APITORIA PHARMA PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 181922005

ORBION PHARMACEUTICALS PRIVATE LTDTERBINAFINE HYDROCHLORIDE (NON-STERILE BULK)

DMF 188442005

MSN LABORATORIES PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP [ROUTE CODE - "TF"]

DMF 204132007

ALIVUS LIFE SCIENCES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 212292008

SHANDONG ANHONG PHARMACEUTICAL CO LTDTERBINAFINE HYDROCHLORIDE (NON STERILE, API)

DMF 257052012

TIANJIN WEIJIE PHARMACEUTICAL CO LTDTERBINAFINE HYDROCHLORIDE

DMF 304352016

TARO PHARMACEUTICAL INDUSTRIES LTDTERBINAFINE HYDROCHLORIDE USP

DMF 309402017

CHROMO LABORATORIES INDIA PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 317192017

OLON SPATERBINAFINE HYDROCHLORIDE

DMF 324482018

SAPTAGIR LABORATORIES PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 376112022

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDTERBINAFINE HYDROCHLORIDE USP

DMF 377012023

OLON SPATERBINAFINE HYDROCHLORIDE TYPE-2

DMF 383532023

PERRIGO API LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 167842003

RECORDATI ESPANA SLInactiveTERBINAFINE HYDROCHLORIDE

DMF 172912004

MYLAN LABORATORIES LTDInactiveTERBINAFINE HYDROCHLORIDE USP

DMF 182242005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 187582005

AARTI DRUGS LTDInactiveTERBINAFINE HYDROCHLORIDE

DMF 197752006

QILU PHARMACEUTICAL CO LTDInactiveTERBINAFINE HYDROCHLORIDE (NON STERILE, API)

DMF 217172008

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 24, 2017	SUPPL -13	View Letter (PDF)
Aug 23, 2016	SUPPL -11	View Letter (PDF)
Oct 25, 2013	SUPPL -10	View Letter (PDF)
Jun 18, 2013	SUPPL -9	View Letter (PDF)
Apr 25, 2012	SUPPL -7	View Letter (PDF)
Nov 8, 2011	SUPPL -6	View Letter (PDF)
Mar 31, 2011	SUPPL -4	View Letter (PDF)
Dec 7, 2010	SUPPL -3	View Letter (PDF)
Oct 4, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 125MG BASE/PACKET

RLD

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Sep 28, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 187.5MG BASE/PACKET

RLD

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 28, 2007