Cabozantinib s-malate - Generic Drug Details
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What are the generic sources for cabozantinib s-malate and what is the scope of freedom to operate?
Cabozantinib s-malate
is the generic ingredient in two branded drugs marketed by Exelixis and Exelixis Inc, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cabozantinib s-malate has two hundred and thirty-one patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for cabozantinib s-malate
International Patents: | 231 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 42 |
Patent Applications: | 1,299 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cabozantinib s-malate |
DailyMed Link: | cabozantinib s-malate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cabozantinib s-malate
Generic Entry Dates for cabozantinib s-malate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for cabozantinib s-malate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for cabozantinib s-malate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Phase 2 |
Children's Oncology Group | Phase 2/Phase 3 |
National Cancer Institute (NCI) | Phase 2/Phase 3 |
Pharmacology for cabozantinib s-malate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for cabozantinib s-malate
Paragraph IV (Patent) Challenges for CABOZANTINIB S-MALATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CABOMETYX | Tablets | cabozantinib s-malate | 20 mg, 40 mg and 60 mg | 208692 | 1 | 2019-08-16 |
US Patents and Regulatory Information for cabozantinib s-malate
Expired US Patents for cabozantinib s-malate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | 8,497,284 | ⤷ Subscribe |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | 8,497,284 | ⤷ Subscribe |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | 8,497,284 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cabozantinib s-malate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2013009116 | PROCESOS PARA PREPARAR COMPUESTOS DE QUINOLINA Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN TALES COMPUESTOS. (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS.) | ⤷ Subscribe |
European Patent Office | 2392565 | Modulateurs de c-Met et procédés d'utilisation (c-Met modulators and methods of use) | ⤷ Subscribe |
Australia | 2016247044 | C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS | ⤷ Subscribe |
New Zealand | 618004 | Malate salt of n-(4-{ [6,7-bis(methyloxy)quinolin-4-yl]oxy} phenyl)-n’-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, and crystalline forms thereof for the treatment of cancer | ⤷ Subscribe |
Spain | 2402524 | ⤷ Subscribe | |
Singapore | 173014 | MALATE SALT OF N- (4- { [ 6, 7-BIS (METHYLOXY) QUIN0LIN-4-YL] OXY}PHENYL)-N' - (4 -FLUOROPHENYL) CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEROF FOR THE TREATMENT OF CANCER | ⤷ Subscribe |
South Korea | 102088588 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabozantinib s-malate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2213661 | 14C0067 | France | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326 |
2213661 | 43/2014 | Austria | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326 |
2213661 | 2014/052 | Ireland | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
2213661 | C 2014 036 | Romania | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPT DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF FIRST AUTHORISATION IN EEA: 20140321 ABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; |
2213661 | CA 2014 00039 | Denmark | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321 |
2213661 | PA2014033 | Lithuania | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 |
2213661 | 122014000091 | Germany | ⤷ Subscribe | PRODUCT NAME: CABOZANTINIB UND JEDES THERAPEUTISCHE AEQUIVALENT HIERVON WIE DURCH DAS GRUNDPATENT GESCHUETZT, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Cabozantinib s-malate Market Analysis and Financial Projection Experimental
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