SUTENT Drug Patent Profile
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Which patents cover Sutent, and when can generic versions of Sutent launch?
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. Ten 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: | 112 |
Clinical Trials: | 220 |
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 |
---|---|
University of Miami | Phase 2 |
National Anti Doping Laboratory, Belarus | Phase 1 |
JLLC NatiVita | Phase 1 |
Pharmacology for SUTENT
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 |
---|---|---|---|
Hungary | 228979 | PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS | ⤷ Try a Trial |
Canada | 2395461 | PROCEDES DE MODULATION DE LA FONCTION KINASE DE PROTEINE TYROSINE DE TYPE C-KIT AVEC DES COMPOSES INDOLINONE (METHODS OF MODULATING C-KIT TYROSINE KINASE FUNCTION WITH INDOLINONE COMPOUNDS) | ⤷ Try a Trial |
Iceland | 6501 | ⤷ Try a Trial | |
Spain | 2290117 | ⤷ Try a Trial | |
Norway | 2019005 | ⤷ Try a Trial | |
Serbia | 50444 | INHIBITORI 2-INDOLINON PROTEIN KINAZE SUPSTITUISANI PIROLOM (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS) | ⤷ Try a Trial |
South Korea | 20030003229 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUTENT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1255752 | C 2010 003 | Romania | ⤷ Try a Trial | 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 | PA2008002,C1255752 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719 |
1255752 | SPC003/2010 | Ireland | ⤷ Try a Trial | SPC003/2010: 20100702, EXPIRES: 20240922 |
1255752 | 132010901817031 | Italy | ⤷ Try a Trial | PRODUCT NAME: TOCERANIB FOSFATO(PALLADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/09/100/001-002-003, 20090923 |
1255752 | SPC004/2008 | Ireland | ⤷ Try a Trial | SPC004/2008: 20081105, EXPIRES: 20210718 |
1255752 | SPC/GB10/008 | United Kingdom | ⤷ Try a 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 | 10C0003 | France | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |