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: | 41 |
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 |
---|---|
Children's Oncology Group | Phase 2/Phase 3 |
National Cancer Institute (NCI) | Phase 2/Phase 3 |
OHSU Knight Cancer Institute | Phase 2 |
Pharmacology for CABOZANTINIB S-MALATE
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
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
International Patents for CABOZANTINIB S-MALATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2018220045 | C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
Japan | 2017160270 | c−Metモジュレーターおよびその使用 (c-Met MODULATOR AND ITS USE) | ⤷ Try a Trial |
Taiwan | 202112751 | Pharmaceutical composition comprising malate salt of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide and use thereof | ⤷ Try a Trial |
South Korea | 20180056807 | C-MET 조절제 약제학적 조성물 (C-MET C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
Australia | 2004275842 | c-MET modulators and methods of use | ⤷ Try a Trial |
Portugal | 2593090 | ⤷ Try a Trial | |
Croatia | P20140012 | ⤷ Try a Trial | |
>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 | 92508 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB ET TOUTES LES FORMES THERAPEUTIQUEMENT EQUIVALENTES QUI EN DERIVENT TELLES QUE PROTEGEES PAR LE BREVET DE BASE, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140326 |
2213661 | C 2014 036 | Romania | ⤷ Try a Trial | 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 | 14C0067 | France | ⤷ Try a Trial | 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 | PA2014033,C2213661 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 |
2213661 | 2014/052 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 |
2213661 | 583 | Finland | ⤷ Try a Trial | |
2213661 | 122014000091 | Germany | ⤷ Try a Trial | 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 |
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