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Last Updated: October 17, 2019

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Sunitinib malate - Generic Drug Details

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What are the generic sources for sunitinib malate and what is the scope of freedom to operate?

Sunitinib malate is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sunitinib malate has seventy-eight patent family members in forty-one countries.

There are eight drug master file entries for sunitinib malate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for sunitinib malate

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

SponsorPhase
Graybug VisionPhase 2
VU University Medical CenterPhase 2/Phase 3
University of Colorado, DenverPhase 1

See all sunitinib malate clinical trials

Recent Litigation for sunitinib malate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Mylan Inc.2010-06-16

See all sunitinib malate litigation

Generic filers with tentative approvals for SUNITINIB MALATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 50MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 37.5MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 25MG BASECAPSULE;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 sunitinib malate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for sunitinib malate
(-)-malic acid; sunitinib
(Z)-N-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-p
(Z)-N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
(Z)-N-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysuccinate
031S547
1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-
1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-, (2S)-hydroxybutanedioate (1:1)
1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-, (2S)-hydroxybutanedioate (1:1)
1H-Pyrrole-3-carboxamide, N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-
1H-Pyrrole-3-carboxamide,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-
1H-Pyrrole-3-carboxamide,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-, (2S)-hydroxybutanedioate (1:1)
1H-Pyrrole-3-carboxamide,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-, malate salt
326914-13-0
341031-54-7
342641-94-5
5-(5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-ethyl)-amide
5-(5-FLUORO-2-OXO-1,2-DIHYDRO-INDOL-3-YLIDENEMETHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXYLIC ACID (2-DIETHYLAMINO-ETHYL)-AMIDE
5-(5-Fluoro-2-oxo-1,2-dihydroindol-3-ylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic Acid (2-diethylaminoethyl)amide
5-[5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-ethyl)-amide
5-[5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid(2-diethylamino-ethyl)-amide
557795-19-4
95S194
AB0017673
AB0020988
AB01273976_04
AB01273976-01
AB01273976-02
AC1NS62J
AC1O5CMQ
AJ-47545
AK544273
AKOS005145765
AKOS015908193
AKOS025149097
AKOS025312424
AM20090630
AM20090634
AN-777
AN-9681
AOB5508
AOB87111
API0024508
API0024677
AT-15587
AX8033294
BCPP000057
BDBM4814
Butanedioic acid, (2S)-, compd. with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1)
Butanedioic acid, (2S)-, compd. with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1) (CA INDEX NAME)
Butanedioic acid, 2-hydroxy-, (2S)-, compd. with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1)
Butanedioic acid, hydroxy-, (2S)-, compd. with N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1)
C22H27FN4O2
C26H33FN4O7
CCG-221818
CF-876
CHEBI:38940
CHEBI:91430
CHEMBL1567
CHEMBL535
CS-0177
CS-1670
D06402
D08552
DB01268
EN002687
EX-A553
FT-0083555
FT-0083556
GTPL5713
HMS3261H09
HSDB 7932
HY-10255
HY-10255A
I01-1229
J-019449
J90060
K00588a
KB-80777
KS-5022
KS-5023
LBWFXVZLPYTWQI-IPOVEDGCSA-N
LS-186078
LS-187023
LS-187648
LVX8N1UT73
MFCD08282795
MolPort-003-986-763
MolPort-006-167-758
N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-
N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1 pound not2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2 pound not4-dimethyl-1H-pyrrole-3-carboxamide
N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-hydroxybutanedioate
N-(2-diethylaminoethyl)-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-(2-diethylaminoethyl)-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; (2S)-2-hydroxybutanedioic acid
N-[2-(Diethylamino)ethyl]-5-(2-oxo-5-fluoroindoline-3-ylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-2,3-dihydro-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
n-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide
N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-2-hydroxybutanedioic acid (1:1) salt
N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-2-hydroxybutanedioate salt
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide;(2S)-2-hydroxybutanedioic acid
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-indolin-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-indolin-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide; (2S)-2-hydroxybutanedioic acid
N-[2-(diethylamino)ethyl]-5-{[(3Z)-5-fluoro-2-oxo-2,3-dihydro-1H-indol-3-ylidene]methyl}-2,4-dimethyl-1H-pyrrole-3-carboxamide
N-[5-(Trifluoromethyl)-2-pyridinyl]-trans-4-[[(1,1-dimethylethyl)sulfonyl]amino]cyclohexane-1-carboxamide
NCGC00164631-02
NCGC00164631-04
NCGC00261199-01
NSC-736511
NSC-750690
NSC736511
NSC750690
PDGF TK antagonist
PHA-290940AD
PNU-290940AD
Q572
QCR-103
QCR-67
RL03260
s1042
s7781
SC-47294
SCHEMBL1258610
SCHEMBL1772213
SCHEMBL8081
SR-00000000005
SR-00000000005-2
ST2413814
SU 011248
SU 11248
SU-010398
Su-011248
SU-011248 L-malate salt
SU-11248
SU-11248 L-malate salt
SU-11248J
SU010398
SU011248
SU011248 L-malate salt
SU112248
SU11248
Sunitinib
Sunitinib (free base)
Sunitinib (INN)
Sunitinib [INN:BAN]
Sunitinib Base
Sunitinib malate (JAN/USAN)
Sunitinib Malate (Sunitinib L-Malate)
Sunitinib Malate (Sutent)
Sunitinib malate [USAN]
Sunitinib malate, >=98% (HPLC)
Sunitinib Malate|341031-54-7|Sutent|SU-11248|Sunitinib
SUNITINIB MALEATE
sunitinibum
Sutent
Sutent (free base)
Sutent (TN)
Sutent (TN) (Pfizer)
Sutent, Sunitinib, SU11248
SW219407-1
TL8002546
Tox21_500514
UNII-LVX8N1UT73
UNII-V99T50803M
V2095
V99T50803M
W-2596
WINHZLLDWRZWRT-ATVHPVEESA-N
X-1524
ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
yrrole-3-carboxamide
Z2568722545
ZINC3964325

US Patents and Regulatory Information for sunitinib malate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 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

Supplementary Protection Certificates for sunitinib malate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 SPC003/2010 Ireland   Start Trial SPC003/2010: 20100702, EXPIRES: 20240922
1255752 300332 Netherlands   Start Trial PRODUCT NAME: SUNITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET L-MALAATZOUT; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060724
1255752 378 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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