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Last Updated: May 26, 2022

SUTENT Drug Patent 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.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Six suppliers are 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

Recent Clinical Trials for SUTENT

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

SponsorPhase
JLLC NatiVitaPhase 1
National Anti Doping Laboratory, BelarusPhase 1
Jiangsu HengRui Medicine Co., Ltd.Phase 3

See all SUTENT clinical trials

Paragraph IV (Patent) Challenges for SUTENT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUTENT Capsules sunitinib malate 12.5 mg, 25 mg, 37.5 mg and 50 mg 021938 1 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 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SUTENT

See the table below for patents covering SUTENT around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1255752 INHIBITEURS DE LA PROTEINE KINASE 2-INDOLINONE A SUBSTITUTION PYRROLE (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS) See Plans and Pricing
Czech Republic 20023081 See Plans and Pricing
Eurasian Patent Organization 200200862 See Plans and Pricing
Australia 3977001 See Plans and Pricing
Germany 122010000004 See Plans and Pricing
Slovakia 13262002 Inhibítory proteínkináz na báze pyrolom substituovaného 2-indolinónu (Pyrrole substituted 2-indolinone protein kinase inhibitors) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUTENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 2008/004 Ireland See Plans and Pricing PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE L-MALATE SALT; AUTHORISATION NO/DATE: IRELAND EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752 C01255752/02 Switzerland See Plans and Pricing PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010
1255752 C 2010 003 Romania See Plans and Pricing PRODUCT NAME: (Z)-5-[(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL}-2,4-DIMETIL-N-(2-PIROLIDIN-1-ILETIL)-1H-PIROL-3-CARBOXAMIDA - TOCERANIB, INCLUSIV SUB FORMA DE FOSFAT; NATIONAL AUTHORISATION NUMBER: RO EU/2/09/100/001, RO EU/2/09/100/002, RO EU/2/09/100/003; DATE OF NATIONAL AUTHORISATION: 20090923; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/2/09/100/001, EMEA EU/2/09/100/002, EMEA EU/2/09/100/003; DATE OF FIRST AUTHORISATION IN EEA: 20090923
1255752 CA 2008 00015 Denmark See Plans and Pricing PRODUCT NAME: SUNITINIB EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER L-MALEATSALTET
1255752 122010000004 Germany See Plans and Pricing PRODUCT NAME: TOCERANIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/2/09/100/001-003 20090923
1255752 10C0003 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Boehringer Ingelheim
Colorcon
Medtronic
Mallinckrodt

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