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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sutent
A generic version of SUTENT was approved as sunitinib malate by SUN PHARM on August 16th, 2021.
Summary for SUTENT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 217 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SUTENT |
What excipients (inactive ingredients) are in SUTENT? | SUTENT excipients list |
DailyMed Link: | SUTENT at DailyMed |


Recent Clinical Trials for SUTENT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
JLLC NatiVita | Phase 1 |
National Anti Doping Laboratory, Belarus | Phase 1 |
Jiangsu HengRui Medicine Co., Ltd. | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for SUTENT
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 |