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Last Updated: December 12, 2019

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FLUVOXAMINE MALEATE Drug Profile

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When do Fluvoxamine Maleate patents expire, and when can generic versions of Fluvoxamine Maleate launch?

Fluvoxamine Maleate is a drug marketed by Actavis Elizabeth, Anchen Pharms, Torrent, Ani Pharms Inc, Apotex, Eci Pharms Llc, Heritage Pharma, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs. and is included in sixteen NDAs.

The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Fluvoxamine Maleate

A generic version of FLUVOXAMINE MALEATE was launched as fluvoxamine maleate by UPSHER SMITH LABS on December 12th, 2019.

Drug patent expirations by year for FLUVOXAMINE MALEATE
Drug Prices for FLUVOXAMINE MALEATE

See drug prices for FLUVOXAMINE MALEATE

Recent Clinical Trials for FLUVOXAMINE MALEATE

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Guangdong General HospitalPhase 4
Meiji Seika Pharma Co., Ltd.Phase 3

See all FLUVOXAMINE MALEATE clinical trials

Recent Litigation for FLUVOXAMINE MALEATE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Elan Pharma International Limited v. Anchen Pharmaceuticals Inc

See all FLUVOXAMINE MALEATE litigation

Pharmacology for FLUVOXAMINE MALEATE
Synonyms for FLUVOXAMINE MALEATE
(2-aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine; but-2-enedioic acid
(E)-5-Methoxy-1-(4-(trifluoromethyl)phenyl)-1-pentanone O-(2-aminoethyl)oxime (Z)-2-butenedioate (1:1)
(E)-5-Methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-one O-(2-aminoethyl) oxime maleate
(E)-5-Methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-one O-(2-aminoethyl)oxime maleate
(E)-5-methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-one O-2-aminoethyl oxime maleate
(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl)-1-pent
(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-(2-Aminoethyl)oxime Maleate
(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-O-(2-aminoethyl)oxime maleate
(E)-5-Methoxy-1-[4-(triflurormethyl)phenyl]-1-pentanone O-(2-Aminoethyl)oxime Maleate
(E)-Fluvoxamine Maleate
(Z)-2-butenedioic acid; 2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
(Z)-but-2-enedioic acid; 2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
(Z)-but-2-enedioic acid; 2-[(Z)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
(Z)-but-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
1-Pentanone, 5-methoxy-1-(4-(trifluoromethyl)phenyl)-, O-(2-aminoethyl)oxime, (E)-, (Z)-2-butenedioate (1:1)
1-Pentanone, 5-methoxy-1-(4-(trifluoromethyl)phenyl)-, O-(2-aminoethyl)oxime,(E)-, (Z)-2-butenedioate (1:1)
1246666-24-9
2-[({(1E)-5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene}amino)oxy]ethanamine (2Z)-but-2-enedioate
5-Methoxy-4'-(trifluoromethyl)valerophenone (E)-O-(2-aminoethyl)oxime, maleate (1:1)
5-Methoxy-4'-trifluoromethylvalerophenone (E)-O-2-aminoethyloxime monomaleate
54739-18-3
54739-18-3 (Parent)
54739-20-7
5LGN83G74V
61718-82-9
739F183
A833394
AB2000054
AC-9541
AC1NTMLT
AKOS015855869
AKOS015906773
AKOS015961142
AKOS030242722
AN-39241
ANW-64083
API0002751
AS-11790
AX8016087
BCP06470
BG0368
C15H21F3N2O2.C4H4O4
C19H25F3N2O6
CCG-213494
CHEBI:5139
CHEMBL1409
CPD000466268
CS-1839
CTK8C0093
D00824
Depromel
DTXSID3042558
DU-23000
DU23000
Dumirox
EN300-122372
EU-0100495
F 2802
F0858
Faverin
Fevarin
Floxyfral
fluvoxamin e
Fluvoxamine (maleate)
Fluvoxamine for system suitability, European Pharmacopoeia (EP) Reference Standard
Fluvoxamine maleate (JP17/USAN)
Fluvoxamine maleate [USAN:USP]
Fluvoxamine maleate [USAN]
Fluvoxamine maleate, 1.0 mg/mL in methanol ((as free base)), certified reference material
Fluvoxamine maleate, British Pharmacopoeia (BP) Reference Standard
Fluvoxamine maleate, European Pharmacopoeia (EP) Reference Standard
Fluvoxamine Maleate, Pharmaceutical Secondary Standard; Certified Reference Material
Fluvoxamine maleate, solid
Fluvoxamine maleate, United States Pharmacopeia (USP) Reference Standard
Fluvoxaminemaleate
FT-0626496
GP8417
HMS1571G11
HMS2098G11
HMS3261D11
HMS3267A08
HMS3370O21
HMS3371G18
HMS3373J05
HMS3393E15
HMS3604H15
HMS3654B17
HMS3715G11
HY-B0103A
J90043
KB-209260
KS-00000XLE
KS-1063
LFMYNZPAVPMEGP-PIDGMYBPSA-N
LP00495
LS-102000
Luvox
Luvox (TN)
Luvox CR
maleic acid; 2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine
Maveral
MCULE-4841680762
MFCD00269809
MK-264
MLS000028469
MLS000758271
MLS001076285
MLS001304717
MLS001401391
MLS006011983
MolPort-002-885-827
MolPort-003-666-870
MolPort-027-714-052
NCGC00093897-01
NCGC00093897-02
NCGC00261180-01
NE47064
NSC 309469
NSC-309469
NSC-759602
NSC309469
NSC759602
Pharmakon1600-01505604
s1336
SAM001246977
SCHEMBL35225
SCHEMBL782847
SME 3110
SME-3110
SMR000058449
SMR000466268
SMR000653482
SMR004703541
SR-01000075613
SR-01000075613-1
SR-01000075613-3
SR-01000075613-4
SR-01000075613-6
ST24035070
SW197282-4
TC-063925
TL8003932
Tox21_500495
UNII-5LGN83G74V
Z1583164922
Paragraph IV (Patent) Challenges for FLUVOXAMINE MALEATE
Tradename Dosage Ingredient NDA Submissiondate
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 2009-04-20
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 2009-04-13

US Patents and Regulatory Information for FLUVOXAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075887-002 Jan 5, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 076125-003 Apr 29, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075889-003 Nov 29, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Synthon Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075899-001 Jan 17, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075950-002 Oct 15, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth FLUVOXAMINE MALEATE fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 091482-001 Apr 23, 2013 AB RX 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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