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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Last Updated: December 9, 2019

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Terbinafine hydrochloride - Generic Drug Details

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What are the generic sources for terbinafine hydrochloride and what is the scope of freedom to operate?

Terbinafine hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Novartis, Taro, Glaxosmithkline Cons, 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-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for terbinafine hydrochloride. Forty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for terbinafine hydrochloride

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 hydrochloride clinical trials

Recent Litigation for terbinafine hydrochloride

Identify potential future generic entrants

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

See all terbinafine hydrochloride litigation

Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE
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.

Pharmacology for terbinafine hydrochloride
Synonyms for terbinafine hydrochloride
(2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine hydrochloride
(2E)-N,6,6-Trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine hydrochloride (1:1)
(2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-aminium chloride
(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride
(E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine hydrochloride
(E)-N-(6,6-DIMETHYL-2-HEPTEN-4-YNYL)-N-METHYL-1-NAPHTHYLMETHYLAMINE HYDROCHLORIDE
(E)-N,6,6-trimethyl-N-(1-naphthalenylmethyl)-1-hept-2-en-4-ynamine hydrochloride
(E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine hydrochloride
(E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine hydrochloride
(E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine;hydrochloride
012C11ZU6G
1-Naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-, (E)-, monohydrochloride
1-Naphthalenemethanamine, N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-, (E)-,monohydrochloride
628T805
78628-80-5
A1-01779
A839463
AB0013345
AB03963
AB2000653
AC-761
AC1NR04Y
Afogan
AK161974
AKOS015844100
AKOS025149216
AN-6967
API0004353
Athletes foot
B2047
BC220359
BCP22693
BCP9000834
BWMISRWJRUSYEX-SZKNIZGXSA-N
C-19912
C21H25N.HCl
C21H26ClN
CCG-101026
CHEBI:77614
CHEMBL1200832
CPD000469152
CS-1123
CT0259
D02219
D2049
DRG-0286
DTXSID90229223
EC 616-640-4
H901
HTU-520
HY-17395
I06-0127
I06-127
I14-0662
InnoNyx
J10383
KB-60713
KS-1289
Lamisil
Lamisil (TN)
Lamisil AT
Lamisil Krem
LS-94723
MFCD00145430
MLS001066620
MLS001304037
MLS001401424
MolPort-001-758-011
mycoCeaze
MycoVa
N-[(2E)-6,6-Dimethyl-2-hepten-4-yn-1-yl]-N-methyl-1-naphthalenemethanamine hydrochloride
NC00276
NM-100060
NSC-759113
NSC759113
Pharmakon1600-01505392
Q-201790
s2557
SAM001246565
SBB066075
SC-14146
SCHEMBL36793
SCHEMBL36795
Sebifin
SF 86-327 hydrochloride
SF-86327
SMR000469152
ST24049333
SW197656-2
TerbiFoam
Terbinafina
Terbinafina [Spanish]
Terbinafine (hydrochloride)
Terbinafine for system suitability, European Pharmacopoeia (EP) Reference Standard
Terbinafine HCl
Terbinafine HCl (Lamisil)
Terbinafine hydrochioride
Terbinafine hydrochloride (JP17/USP)
Terbinafine hydrochloride (Lamisil)
Terbinafine hydrochloride [USP:JAN]
Terbinafine hydrochloride, >=98%
Terbinafine hydrochloride, 99%
Terbinafine hydrochloride, Antibiotic for Culture Media Use Only
Terbinafine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Terbinafine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Terbinafine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Terbinafine Hydrochloride,(S)
terbinafine monohydrochloride
Terbinafine,hydrochloride
Terbinafinum
Terbinafinum [Latin]
Terbisil
TR-025130
TRANS-N-(6,6-DIMETHYL-2-HEPTEN-4-YLYL)-N-METHYL-1-NAPHTHYLMETHYLAMINE HYDROCHLORIDE
trans-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthylmethylamine Hydrochloride
Trebinafine hydrochloride
UNII-012C11ZU6G
W-5081
Zabel
Zimig
Paragraph IV (Patent) Challenges for TERBINAFINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
LAMISIL TABLET;ORAL terbinafine hydrochloride 020539

US Patents and Regulatory Information for terbinafine hydrochloride

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 hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Apotex TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078199-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077195-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020192-001 Dec 30, 1992 DISCN 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
>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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000   Start Trial   Start Trial
Glaxosmithkline LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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