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. 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.
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Questions you can ask:
- What is the 5 year forecast for SUTENT?
- What are the global sales for SUTENT?
- What is Average Wholesale Price for SUTENT?
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|
Portugal | 1255536 | ⤷ Sign Up | |
Brazil | PI0117360 | inibidores de proteína de quinase de 2-indolinona de pirrol substituído, seus sais e composições farmacêuticas compreendendo os mesmos | ⤷ Sign Up |
Canada | 2399358 | INHIBITEURS DE LA PROTEINE KINASE 2-INDOLINONE A SUBSTITUTION PYRROLE (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS) | ⤷ Sign Up |
Costa Rica | 20120009 | 2-INDOLINONAS SUSTITUIDAS CON PIRROLOS INHIBIDORES DE PROTEINQUINASAS (DIVISIONAL EXP. 6728) | ⤷ Sign Up |
Denmark | 1255752 | ⤷ Sign Up | |
Japan | 3663382 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 0160814 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SUTENT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1255752 | CA 2010 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT |
1255752 | PA2010002 | Lithuania | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 5/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719 |
1255752 | C200800007 | Spain | ⤷ Sign Up | 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 |
1255752 | 91657 | Luxembourg | ⤷ Sign Up | 91657, EXPIRES: 20240923 |
1255752 | PA2008002,C1255752 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |