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Last Updated: November 20, 2019

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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 eighty patent family members in forty-one countries.

The generic ingredient in SUTENT is sunitinib malate. There are eight 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
Drug Prices for SUTENT

See drug prices for SUTENT

Generic Entry Opportunity Date for SUTENT
Generic Entry Date for SUTENT*:
Constraining patent/regulatory exclusivity:
PEDIATRIC EXCLUSIVITY
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SUTENT

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

SponsorPhase
Milton S. Hershey Medical CenterPhase 1
Eli Lilly and CompanyPhase 1
Deciphera Pharmaceuticals LLCPhase 3

See all SUTENT clinical trials

Recent Litigation for SUTENT

Identify potential future generic entrants

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

See all SUTENT litigation

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-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
AB01273976_04
AB01273976-01
AB01273976-02
AC1NS62J
AJ-47545
AKOS015908193
AKOS025312424
AM20090630
AN-9681
AOB87111
API0024677
AX8033294
BCPP000057
BDBM4814
C22H27FN4O2
CF-876
CHEBI:38940
CHEBI:91430
CHEMBL535
CS-1670
D08552
DB01268
EN002687
EX-A553
FT-0083556
GTPL5713
HSDB 7932
HY-10255A
I01-1229
J90060
K00588a
KB-80777
KS-5022
LS-187023
LS-187648
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-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
Q572
QCR-67
s7781
SC-47294
SCHEMBL8081
SR-00000000005
SR-00000000005-2
ST2413814
SU 11248
Su-011248
SU-11248
SU11248
Sunitinib
Sunitinib (free base)
Sunitinib (INN)
Sunitinib [INN:BAN]
Sunitinib Base
Sunitinib malate
sunitinibum
Sutent (free base)
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
Paragraph IV (Patent) Challenges for SUTENT
Tradename Dosage Ingredient NDA Submissiondate
SUTENT CAPSULE;ORAL sunitinib malate 021938 2010-01-26

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   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 Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 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   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No   Start Trial   Start Trial Y   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 SUTENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 5/2008 Austria   Start Trial PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719
1255752 C 2008 002 Romania   Start Trial PRODUCT NAME: N-[2-(DIETILAMINO)ETIL]-5-[(Z)-(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL]-2,4-DIMETIL-1H-PIROL-3-CAROXAMIDA - SUNITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC,INCLUSIV A SARII L-MALAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/06/347/001, RO EU/1/06/347/002, RO EU/1/06/347/003; DATE OF NATIONAL AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003; DATE OF FIRST AUTHORISATION IN EEA: 20060719
1255752 SPC004/2008 Ireland   Start Trial SPC004/2008: 20081105, EXPIRES: 20210718
1255752 2010C/009 Belgium   Start Trial PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923
1255752 312 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
McKesson
Mallinckrodt
Harvard Business School
Baxter

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