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Last Updated: July 6, 2020

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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.

This drug has eighty patent family members in forty-two 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.

US ANDA Litigation and Generic Entry Outlook for Sutent

Sutent was eligible for patent challenges on January 26, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2021. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (sunitinib malate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for SUTENT
Drug Prices for SUTENT

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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.

Recent Clinical Trials for SUTENT

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

SponsorPhase
Ulrik LassenPhase 2
GlaxoSmithKlinePhase 2
Roche Pharma AGPhase 2

See all SUTENT clinical trials

Pharmacology for SUTENT
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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 PA2010002,C1255752 Lithuania   Start Trial PRODUCT NAME: TOCERANIBUM; REGISTRATION NO/DATE: EU/2/09/100/001, 2009 09 23 EU/2/09/100/002, 2009 09 23 EU/2/09/100/003 20090923
1255752 CA 2008 00015 Denmark   Start Trial PRODUCT NAME: SUNITINIB EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER L-MALEATSALTET
1255752 SPC/GB08/007 United Kingdom   Start Trial PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L-MALATE SALT.; REGISTERED: UK EU/1/06/347/001 20060724; UK EU/1/06/347/002 20060724; UK EU/1/06/347/003 20060724
1255752 312 Finland   Start Trial
1255752 CA 2010 00004 Denmark   Start Trial PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Boehringer Ingelheim
Colorcon
Medtronic
Mallinckrodt

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