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Generated: August 16, 2018

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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 sunitinib malate 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-three patent family members in thirty-nine countries.

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

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-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
AK-25799
AK-98158
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
D0R0MW
DB01268
EN002687
EX-A553
FT-0083555
FT-0083556
GTPL5713
HE071230
HE352691
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
MFCD09260778
MFCD09743439
MolPort-003-986-763
MolPort-006-167-758
N-(2- -5-( - -2,4-dimethyl-1H-pyrrole-3-carboxamide -hydroxybutanedioate
N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-
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
ST51053712
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
Sunitanib
Sunitinib
Sunitinib (free base)
Sunitinib (INN)
Sunitinib (Pan-TK inhibitor)
Sunitinib [INN:BAN]
Sunitinib Base
Sunitinib malate (JAN/USAN)
Sunitinib Malate (Sunitinib L-Malate)
Sunitinib malate [USAN]
Sunitinib malate, >=98% (HPLC)
Sunitinib Malate|341031-54-7|Sutent|SU-11248|Sunitinib
SUNITINIB MALEATE
Sunitinib, Free base
sunitinibum
Sutent
Sutent (free base)
Sutent (TN)
Sutent (TN) (Pfizer)
Sutent, Sunitinib, SU11248
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
Tentative approvals for SUNITINIB MALATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 12.5MG BASECAPSULE;ORAL
➤ Sign Up➤ Sign UpEQ 50MG BASECAPSULE;ORAL
➤ Sign Up➤ Sign UpEQ 37.5MG BASECAPSULE;ORAL

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 021938-003 Jan 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Non-Orange Book US Patents for sunitinib malate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,572,924 Pyrrole substituted 2-indolinone protein kinase inhibitors ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for sunitinib malate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752/02 Switzerland ➤ Sign Up PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010
C003/2010 Ireland ➤ Sign Up SPC003/2010: 20100702, EXPIRES: 20240922
2008000002 Germany ➤ Sign Up PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALATSALZES; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060719
2008002 Lithuania ➤ Sign Up PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
C/GB10/008 United Kingdom ➤ Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/008 GRANTED TO SUGEN INC. AND PHARMACIA AND UPJOHN COMPANY LLC IN RESPECT OF THE PRODUCT TOCERANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE PHOSPHATE SALT.?, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6380 DATED 31 AUGUST 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 24 SEPTEMBER 2024
C004/2008 Ireland ➤ Sign Up SPC004/2008: 20081105, EXPIRES: 20210718
2 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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