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Last Updated: December 6, 2019

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Toremifene citrate - Generic Drug Details

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What are the generic sources for toremifene citrate and what is the scope of patent protection?

Toremifene citrate is the generic ingredient in two branded drugs marketed by Kyowa Kirin and Rising, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for toremifene citrate. Two suppliers are listed for this compound.

Recent Clinical Trials for toremifene citrate

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

SponsorPhase
Fred Hutchinson Cancer Research CenterPhase 4
National Cancer Institute (NCI)Phase 4
Federal University of São PauloPhase 4

See all toremifene citrate clinical trials

Pharmacology for toremifene citrate
Medical Subject Heading (MeSH) Categories for toremifene citrate
Synonyms for toremifene citrate
(Z)-2-(4-(4-chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)-N,N-dimethylethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylate
(Z)-2-(4-(4-chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)-N,N-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate
(Z)-2-(4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy)-N,N-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate
(Z)-2-[4-(4-Chloro-1,2-diphenyl-1-butenyl)phenoxy]-N,N-dimethylethanamine Citrate
(Z)-2-[4-(4-chloro-1,N- dimethylethanamine, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
(Z)-4-Chloro-1-(4-dimethylaminoethoxyphenyl)-1,2-diphenyl-1-butene Citrate
(Z)-4-Chloro-1,2-diphenyl-1-(4-(2-(N,N-dimethylamino)ethoxy)phenyl)-1-butene citrate (1:1)
2-({4-[(1Z)-4-chloro-1,2-diphenylbut-1-en-1-yl]phenyl}oxy)-N,N-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt)
2-(p-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)-N,N-dimethylethylamine citrate (1:1)
2-(para-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)-N,N-dimethylethylamine citrate (1:1)
2-[4-(4-chloro-1,2-diphenylbut-1-en-1-yl)phenoxy]-n,n-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate(1:1)
2-[4-[(Z)-4-chloranyl-1,2-diphenyl-but-1-enyl]phenoxy]-N,N-dimethyl-ethanamine; 2-oxidanylpropane-1,2,3-tricarboxylic acid
2-[4-[(Z)-4-chloro-1,2-diphenyl-but-1-enyl]phenoxy]-N,N-dimethyl-ethanamine; citric acid
2-[4-[(Z)-4-chloro-1,2-diphenylbut-1-enyl]phenoxy]-N,N-dimethylethanamine; 2-hydroxypropane-1,2,3-tricarboxylic acid
2-[p-[(Z)-4-Chloro-1,2-diphenyl-1-butenyl]phenoxy]-N,N-dimethylethylamine citrate (1:1)
2-[p-[(Z)-4-chloro-1,N- dimethylethylamine citrate (1:1)
2-{4-[4-chloro-1,2-diphenylbut-1-en-1-yl]phenoxy}-N,N-dimethylethanamine 2-hydroxypropane-1,2,3-tricarboxylate (salt)
2498Y783QT
778T267
89778-26-7 (Parent)
89778-27-8
A843307
AB2000287
AC-1985
AC1MHJ30
AC1Q5SNQ
AK139145
AKOS015888270
AN-14397
BC215662
BG0531
CAS-89778-27-8
CCG-101072
CCRIS 6719
CHEBI:9636
CHEMBL1200675
citro; toremifene
CPD000469213
CS-1272
D00967
DSSTox_CID_1367
DSSTox_GSID_21367
DSSTox_RID_76113
DTXSID2021367
Ethanamine, 2-(4-(4-chloro-1,2-diphenyl-1-butenyl)phenoxy)-N,N-dimethyl-, (Z)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
Fareston
Fareston;Acapodene
FC 1157a
HMS2052C03
HMS2230P09
HMS3264L11
HY-B0005
I01-1039
IWEQQRMGNVVKQW-OQKDUQJOSA-N
KM2865
KS-5242
LS-64922
MLS001306432
MLS006011608
NC00322
NCGC00255310-01
NK 622
NSC 613680
NSC-613680
NSC-759190
NSC613680
NSC759190
Pharmakon1600-01505682
s1776
S962
SAM001246774
SCHEMBL4564
SMR004703372
SR-01000763502-3
ST24050182
SW197702-3
TL8005784
Toremifene (Citrate)
Toremifene Citrate (Fareston, Acapodene)
Toremifene citrate (JAN/USAN)
Toremifene citrate [USAN]
Toremifene citrate salt, >=98% (HPLC)
Tox21_111877
Tox21_301740
UNII-2498Y783QT

US Patents and Regulatory Information for toremifene citrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising TOREMIFENE CITRATE toremifene citrate TABLET;ORAL 208813-001 Dec 4, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Kyowa Kirin FARESTON toremifene citrate TABLET;ORAL 020497-001 May 29, 1997 AB RX 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

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