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Last Updated: April 10, 2021

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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 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 eighty patent family members in forty-two countries.

There are eight drug master file entries for sunitinib malate. Two suppliers are listed for this compound.

Summary for sunitinib malate
International Patents:80
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 8
Suppliers / Packagers: 2
Bulk Api Vendors: 158
Clinical Trials: 159
Patent Applications: 7,482
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in sunitinib malate?sunitinib malate excipients list
DailyMed Link:sunitinib malate at DailyMed
Recent Clinical Trials for sunitinib malate

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

SponsorPhase
Graybug VisionPhase 2
VU University Medical CenterPhase 2/Phase 3
University of Colorado, DenverPhase 1

See all sunitinib malate clinical trials

Pharmacology for sunitinib malate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for SUNITINIB MALATE
Tradename Dosage Ingredient NDA Submissiondate
SUTENT CAPSULE;ORAL sunitinib malate 021938 2010-01-26

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   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
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 021938-003 Jan 26, 2006 RX Yes Yes   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
>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 sunitinib malate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 378 Finland   Start Trial
1255752 PA2010002 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 10C0003 France   Start Trial 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
1255752 SPC/GB10/008 United Kingdom   Start Trial 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
1255752 SPC004/2008 Ireland   Start Trial SPC004/2008: 20081105, EXPIRES: 20210718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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