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Last Updated: December 9, 2019

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Terbinafine - Generic Drug Details

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What are the generic drug sources for terbinafine and what is the scope of patent protection?

Terbinafine is the generic ingredient in three branded drugs marketed by Glaxosmithkline Cons, Glaxosmithkline, Novartis, Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Heritage Pharma, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, and Wockhardt, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for terbinafine. There are four tentative approvals for this compound.

Drug Prices for terbinafine

See drug prices for terbinafine

Drug Sales Revenue Trends for terbinafine

See drug sales revenues for terbinafine

Recent Clinical Trials for terbinafine

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

SponsorPhase
United LaboratoriesPhase 2
Postgraduate Institute of Medical Education and ResearchPhase 2
L.V. Prasad Eye InstitutePhase 2/Phase 3

See all terbinafine clinical trials

Recent Litigation for terbinafine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Network Appliance Inc. v. Sun Microsystems Inc2007-11-30

See all terbinafine litigation

Generic filers with tentative approvals for TERBINAFINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 250MG BASETABLET; ORAL
  Start Trial  Start TrialEQ 250MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 250MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for terbinafine
((E)-6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine
(2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine
(2E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine
(2E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine (HCl)
(6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine
(6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine(Terbinafine)
(6,6-dimethylhept-2-en-4-yn-1-yl)methyl(1-naphthylmethyl)amine hydrochloride
(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalene methanamine
(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine
(E)-N-(6,6-dimethyl-2-heptenynyl)-N-methyl-1-naphthalenementhamin hydrochloride
(E)-N,6,6-trimethyl-N-(1-naphthalenylmethyl)-1-hept-2-en-4-ynamine
(E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine
(E)-N,6,6-trimethyl-N-(naphthalen-1
(E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine
[(2E)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)[(naphthalen-1-yl)methyl]amine
[(E)-6,6-dimethyl-hept-2-en-4-ynyl]-methyl-(naphthalen-1-yl-methyl)-amine
1-NAPHTHALENEMETHANAMINE, N-(6,6-DIMETHYL-2-HEPTEN-4-YNYL)-N-METHYL-, (E)-
161T716
1N,6,6-trimethyl-1N-(1-naphthylmethyl)-(E)-2-hepten-4-yn-1-amine
91161-71-6
A843743
AB0007727
AB00698510_12
AB00698510_13
AB00698510_14
AB00698510-07
AB00698510-09
AB00698510-10
AB00698510-11
AB05470
AB2000250
AC-8561
AC1LU7MZ
AK307954
AKOS001451917
ALBB-027269
AN-1287
AT-6016
BBL010959
BCP22896
BDBM50018518
BIDD:GT0825
BRD-K68132782-003-05-4
BRN 4256376
C08079
CAS-91161-71-6
CCG-221253
CHEBI:9448
CHEBI:94705
CHEMBL822
Corbinal
CS-1944
D02375
DB00857
DOMXUEMWDBAQBQ-WEVVVXLNSA-N
DSSTox_CID_3640
DSSTox_GSID_23640
DSSTox_RID_77123
DTXSID2023640
EC 618-706-8
erbinafine hydrochloride
G7RIW8S0XP
GS-3099
HMS2089B20
HMS3715L08
HY-17395A
K662
KB-50552
Lamasil
Lamasil (TN)
Lamisil
Lamisil AT
Lamisil Tablet
Lamisil;Terbinex;Corbinal;Zabel
LS-94722
MFCD00242672
MLS006011885
MolPort-002-507-761
MolPort-004-637-919
N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-methyl-1-naphthalenemethanamine
N,6,6-Trimethyl-N-(1-naphthylmethyl)-2-heptene-4-yne-1-amine
N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine hydrochloride
N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine
NCGC00159346-02
NCGC00159346-03
NCGC00159346-04
NCGC00188975-01
s1725
SBI-0206829.P001
SC-12217
SCHEMBL36794
SCHEMBL37843
SF 86-327
SF-86-327
SF-86327
SMR004703509
STK802069
SW197656-3
terbinafin
Terbinafina
Terbinafine (Lamisil, Terbinex)
Terbinafine (USAN/INN)
Terbinafine [USAN:BAN:INN]
Terbinafine [USAN:INN:BAN]
Terbinafine, SF-86-327, Lamisil, TBNF
Terbinafinum
Terbinex
Tox21_111591
Tox21_111591_1
TX-012572
UNII-G7RIW8S0XP
Zabel
ZINC1530981

US Patents and Regulatory Information for terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Invagen Pharms TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077533-001 Jul 2, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes   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

Expired US Patents for terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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