sutent Drug Patent Profile
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When do Sutent patents expire, 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 |
---|---|---|---|
Eurasian Patent Organization | 005996 | ПИРРОЛЗАМЕЩЕННЫЙ 2-ИНДОЛИНОН, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ), СПОСОБ МОДУЛИРОВАНИЯ КАТАЛИТИЧЕСКОЙ АКТИВНОСТИ ПРОТЕИНКИНАЗЫ, СПОСОБ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ НАРУШЕНИЯ В ОРГАНИЗМЕ, СВЯЗАННОГО С ПРОТЕИНКИНАЗОЙ (PYRROLE SUBSTITUTED 2-INDOLINONE, PHARMACEUTICAL COMPOSITION, METHOD OF MODULATING CATALYTIC ACTIVITY OF PROTEIN KINASE, METHOD OF PREVENTION AND TREATMENT OF DISORDERS RELATED TO PROTEIN KINASE) | ⤷ 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 |
Montenegro | 00415 | PIROL SUPSTITUISANI 2-INDOL PROTEIN KINAZNI INHIBITORI (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS) | ⤷ Try a Trial |
China | 1329390 | ⤷ Try a Trial | |
Australia | 2001239770 | ⤷ 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 2008 002 | Romania | ⤷ Try a Trial | PRODUCT NAME: N-[2-(DIETILAMINO)ETIL]-5-[(Z)-(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL]-2,4-DIMETIL-1H-PIROL-3-CAROXAMIDA - SUNITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC,INCLUSIV A SARII L-MALAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/06/347/001, RO EU/1/06/347/002, RO EU/1/06/347/003; DATE OF NATIONAL AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003; DATE OF FIRST AUTHORISATION IN EEA: 20060719 |
1255752 | SPC003/2010 | Ireland | ⤷ Try a Trial | SPC003/2010: 20100702, EXPIRES: 20240922 |
1255752 | 300332 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SUNITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET L-MALAATZOUT; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060724 |
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 | C200800007 | Spain | ⤷ Try a Trial | PRODUCT NAME: SUNITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/06/347/001-003; DATE OF AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/06/347/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20060719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |