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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Farmers Insurance
Teva
Fuji
Colorcon
US Department of Justice
Fish and Richardson
Cantor Fitzgerald

Generated: May 26, 2018

DrugPatentWatch Database Preview

SUTENT Drug Profile

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When do Sutent patents expire, and what generic alternatives are available?

Sutent is a drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty-nine countries.

The generic ingredient in SUTENT is sunitinib malate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sunitinib malate profile page.
Drug patent expirations by year for SUTENT
Pharmacology for SUTENT
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for SUTENT
(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
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,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-
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
AB01273976_04
AB01273976-01
AB01273976-02
AC1NS62J
AJ-47545
AK-25799
AK-98158
AKOS015908193
AKOS025312424
AM20090630
AN-9681
AOB87111
API0024677
AX8033294
BCPP000057
BDBM4814
C22H27FN4O2
CF-876
CHEBI:38940
CHEBI:91430
CHEMBL535
CS-1670
D08552
D0R0MW
DB01268
EN002687
EX-A553
FT-0083556
GTPL5713
HE352691
HSDB 7932
HY-10255A
I01-1229
J90060
K00588a
KB-80777
KS-5022
LS-187023
LS-187648
MFCD09260778
MFCD09743439
MolPort-006-167-758
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-diethylaminoethyl)-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
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-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-indolin-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
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
NSC-750690
NSC750690
PDGF TK antagonist
Q572
QCR-67
s7781
SC-47294
SCHEMBL8081
SR-00000000005
SR-00000000005-2
ST2413814
SU 11248
SU-010398
Su-011248
SU-11248
SU-11248J
SU11248
Sunitanib
Sunitinib
Sunitinib (free base)
Sunitinib (INN)
Sunitinib (Pan-TK inhibitor)
Sunitinib [INN:BAN]
Sunitinib Base
Sunitinib malate
Sunitinib, Free base
sunitinibum
Sutent (free base)
Sutent (TN)
Sutent, Sunitinib, SU11248
UNII-V99T50803M
V99T50803M
W-2596
WINHZLLDWRZWRT-ATVHPVEESA-N
ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide
yrrole-3-carboxamide
Z2568722545
ZINC3964325

US Patents and Regulatory Information for SUTENT

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 021938-001 Jan 26, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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
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 021938-004 Mar 31, 2009 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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Paragraph IV (Patent) Challenges for SUTENT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 12.5 mg, 25 mg, 37.5 mg and 50 mg ➤ Subscribe 2010-01-26

Non-Orange Book US Patents for SUTENT

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 SUTENT

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
2008 00015 Denmark ➤ Sign Up PRODUCT NAME: SUNITINIB EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER L-MALEATSALTET
2010000004 Germany ➤ Sign Up PRODUCT NAME: TOCERANIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/2/09/100/001-003 20090923
C0003 France ➤ Sign Up PRODUCT NAME: TOCERAMIB ET OPTIONELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET EN PARTICULIER LE PHOSPHATE DE TOCERANIB; REGISTRATION NO/DATE IN FRANCE: EU/2/09/100/001 DU 20090923; REGISTRATION NO/DATE AT EEC: EU/2/09/100/001 DU 20090923
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Healthtrust
Boehringer Ingelheim
Merck
US Department of Justice
Farmers Insurance
Fish and Richardson
Federal Trade Commission
Johnson and Johnson

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