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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 21, 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 terbinafine freedom to operate?

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.

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
Generic filers with tentative approvals for TERBINAFINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET; ORAL
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 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.

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 AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078157-001 Jul 2, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078199-001 Jul 2, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078297-001 Jul 2, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gedeon Richter Usa TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077065-001 Jul 2, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Roxane TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077223-001 Jul 2, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for TERBINAFINE

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

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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. thinkBiotech performs no independent verifification 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.