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Generated: October 17, 2018

DrugPatentWatch Database Preview

SUTENT Drug Profile

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Which patents cover Sutent, 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.

The generic ingredient in SUTENT is sunitinib malate. There are seven 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
Generic Entry Opportunity Date for SUTENT
Generic Entry Date for SUTENT*:
Constraining patent/regulatory 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.

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
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 021938-003 Jan 26, 2006 RX Yes Yes ➤ 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 Date
➤ Subscribe Capsules 12.5 mg, 25 mg, 37.5 mg and 50 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for SUTENT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C003/2010 Ireland ➤ Sign Up SPC003/2010: 20100702, EXPIRES: 20240922
0332 Netherlands ➤ Sign Up
8 Finland ➤ Sign Up
2008002 Lithuania ➤ Sign Up PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
C/GB08/007 United Kingdom ➤ Sign Up PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L- MALATE SALT; REGISTRATION NO/DATE: EU/1/06/347/001 - 003 20060724
C0002 France ➤ Sign Up PRODUCT NAME: SUNITINIB ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUES ACCEPTABLES ET NOTAMMENT LE MALATE DE SUNITINIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/347/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/347/001 DU 20060719
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Healthtrust
Cipla
Covington
Mallinckrodt
Daiichi Sankyo
Baxter
Moodys
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.