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Sunitinib malate - Generic Drug Details
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What are the generic sources for sunitinib malate and what is the scope of patent protection?
Sunitinib malate
is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Sunitinib malate has eighty patent family members in forty-two countries.
There are eight drug master file entries for sunitinib malate. Two suppliers are listed for this compound.
Summary for sunitinib malate
International Patents: | 80 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 8 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 154 |
Clinical Trials: | 159 |
Patent Applications: | 4,673 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in sunitinib malate? | sunitinib malate excipients list |
DailyMed Link: | sunitinib malate at DailyMed |
Recent Clinical Trials for sunitinib malate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Graybug Vision | Phase 2 |
VU University Medical Center | Phase 2/Phase 3 |
University of Colorado, Denver | Phase 1 |
Pharmacology for sunitinib malate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for SUNITINIB MALATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
SUTENT | CAPSULE;ORAL | sunitinib malate | 021938 | 2010-01-26 |
US Patents and Regulatory Information for sunitinib malate
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 | 021938-002 | Jan 26, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-001 | Jan 26, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 sunitinib malate
Country | Patent Number | Estimated Expiration |
---|---|---|
Denmark | 1255752 | Start Trial |
Brazil | PI0117360 | Start Trial |
Netherlands | 300430 | Start Trial |
Japan | 2003523340 | Start Trial |
Luxembourg | 91657 | Start Trial |
Austria | 331514 | Start Trial |
World Intellectual Property Organization (WIPO) | 0145689 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sunitinib malate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1255752 | C200800007 | Spain | Start 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 |
1255752 | CA 2010 00004 | Denmark | Start Trial | PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT |
1255752 | 5/2008 | Austria | Start Trial | 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 | 2008/004 | Ireland | Start Trial | 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 | PA2010002,C1255752 | Lithuania | Start Trial | 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 | SPC003/2010 | Ireland | Start Trial | SPC003/2010: 20100702, EXPIRES: 20240922 |
1255752 | 312 | Finland | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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