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Last Updated: December 12, 2019

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Butenafine hydrochloride - Generic Drug Details

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

Butenafine hydrochloride is the generic ingredient in four branded drugs marketed by Taro Pharms, Bayer Healthcare Llc, and Mylan, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for butenafine hydrochloride. Ten suppliers are listed for this compound.

Recent Clinical Trials for butenafine hydrochloride

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

SponsorPhase
United LaboratoriesPhase 2
Taro Pharmaceuticals USAPhase 1

See all butenafine hydrochloride clinical trials

Pharmacology for butenafine hydrochloride
Synonyms for butenafine hydrochloride
(4-tert-butylphenyl)-N-methyl-N-(naphthalen-1-ylmethyl)methanaminium chloride
1-(4-tert-butylphenyl)-N-methyl-N-(1-naphthalenylmethyl)methanamine hydrochloride
1-(4-tert-butylphenyl)-N-methyl-N-(1-naphthylmethyl)methanamine hydrochloride
1-(4-tert-butylphenyl)-N-methyl-N-(naphthalen-1-ylmethyl)methanamine hydrochloride
101827-46-7
4-tert-butylbenzyl(methyl)(1-naphthalenemethyl)amine hydrochloride
827B467
A800463
A800464
AB0106850
AB07686
AC-2116
AC1L9FCX
AKOS015895328
AN-14303
ANW-42439
API0001792
BC205781
BCP22699
BCP9000464
BG0596
Butenafine (Hydrochloride)
Butenafine HCL
Butenafine hydrochloide
Butenafine hydrochloride (JP17/USAN)
Butenafine hydrochloride [USAN:JAN]
Butenafine hydrochloride, >=98% (HPLC)
C12490
CAS-101827-46-7
CC-25280
CCG-220604
CHEBI:31325
CHEMBL1200397
CS-1124
CTK8B3383
D01093
DSSTox_CID_28515
DSSTox_GSID_48589
DSSTox_RID_82787
DTXSID2048589
FT-0631017
FT-0699734
HY-17396
I06-0721
J-000499
K-0256
KP-363
KS-00000FUA
KS-1035
LJBSAUIFGPSHCN-UHFFFAOYSA-N
Mentax
Mentax (TN)
MFCD00917064
MLS003899213
MolPort-005-934-229
N-((4-(1,1-Dimethylethyl)phenyl)methyl)-N-methyl-1-naphthalenemethanamine hydrochloride
N-(4-(tert-butyl)benzyl)-N-methyl-1-(naphthalen-1-yl)methanamine hydrochloride
N-(4-t-Butylbenzyl)-N-methyl-1-naphthalenemethylamine hydrochloride;N-(4-t-Butylbenzyl)-N-methyl-1-naphthalenemethylamine hydrochloride
N-(4-tert-butylbenzyl)-N-methyl-1-(naphthalen-1-yl)methanamine hydrochloride
N-(4-tert-butylbenzyl)-N-methyl-1-naphthylmethylamine hydrochloride
N-(p-tert-Butylbenzyl)-N-methyl-1-naphthalenemethylamine hydrochloride
N-[[4-(1,1-Dimethylethyl)phenyl]methyl]-N-methyl-1-naphthalenemethanamine hydrochloride
N-4-t-butylbenzyl-N-methyl-1-naphthalenemethylamine hydrochloride
N-4-tert-Butylbenzyl-N-methyl-1-naphthalenemethylamine hydrochloride
R8XA2029ZI
RTR-000443
s3154
SC-17334
SCHEMBL262301
Scorba
SMR002204106
SureCN1648813
SW199070-2
Tox21_112918
TR-000443
UNII-R8XA2029ZI
Volley
Volley (TN)

US Patents and Regulatory Information for butenafine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc LOTRIMIN ULTRA butenafine hydrochloride CREAM;TOPICAL 021307-001 Dec 7, 2001 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Mylan MENTAX butenafine hydrochloride CREAM;TOPICAL 020524-001 Oct 18, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Taro Pharms BUTENAFINE HYDROCHLORIDE butenafine hydrochloride CREAM;TOPICAL 205181-001 Nov 16, 2017 OTC No No   Start Trial   Start Trial   Start Trial
Mylan MENTAX-TC butenafine hydrochloride CREAM;TOPICAL 021408-001 Oct 17, 2002 DISCN No 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

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