JEVTANA KIT Drug Patent Profile
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Which patents cover Jevtana Kit, and what generic alternatives are available?
Jevtana Kit is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has ninety-six patent family members in forty-six countries.
The generic ingredient in JEVTANA KIT is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Jevtana Kit
A generic version of JEVTANA KIT was approved as cabazitaxel by ACCORD HLTHCARE on December 29th, 2021.
Summary for JEVTANA KIT
International Patents: | 96 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 54 |
Patent Applications: | 1,915 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JEVTANA KIT |
DailyMed Link: | JEVTANA KIT at DailyMed |
Recent Clinical Trials for JEVTANA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Andrew J. Armstrong, MD | Phase 2 |
Janssen Pharmaceutica | Phase 2 |
OHSU Knight Cancer Institute | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for JEVTANA KIT
Paragraph IV (Patent) Challenges for JEVTANA KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JEVTANA KIT | Injection | cabazitaxel | 60 mg/1.5 mL | 201023 | 8 | 2014-06-17 |
US Patents and Regulatory Information for JEVTANA KIT
JEVTANA KIT is protected by four US patents.
Patents protecting JEVTANA KIT
Antitumoral use of cabazitaxel
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING AS A 3 WEEK CYCLE CABAZITAXEL AFTER 5 MG DEXCHLORPHENIRAMINE, 8 MG DEXAMETHASONE, AND AN H2-AGONIST
Antitumoral use of cabazitaxel
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INCREASING SURVIVAL IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS PREVIOUSLY TREATED WITH DOCETAXEL BY ADMINISTERING 20 TO 25 MG/M2 CABAZITAXEL AFTER A PREMEDICATION REGIMEN THAT INCLUDES AN H2-ANTAGONIST
Acetone solvate of dimethoxy docetaxel and its process of preparation
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Patent Expiration: ⤷ Sign Up
Antitumoral use of cabazitaxel
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for JEVTANA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for JEVTANA KIT
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Accord Healthcare S.L.U. | Cabazitaxel Accord | cabazitaxel | EMEA/H/C/005178 Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. |
Authorised | yes | no | no | 2020-08-28 | |
Sanofi Winthrop Industrie | Jevtana | cabazitaxel | EMEA/H/C/002018 Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. |
Authorised | no | no | no | 2011-03-17 | |
Teva B.V. | Cabazitaxel Teva | cabazitaxel | EMEA/H/C/004951 Treatment of prostate cancer |
Refused | no | no | no | 2019-07-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for JEVTANA KIT
See the table below for patents covering JEVTANA KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | 222833 | Taxánszármazékot tartalmazó injektálható gyógyszerkészítmények (INJECTABLE MEDICAMENTS CONTAINING TAXANE DERIVATIVES) | ⤷ Sign Up |
El Salvador | 2012004192 | NUEVO USO ANTITUMORAL DE CABAZITAXEL | ⤷ Sign Up |
Canada | 2708489 | UTILISATION ANTITUMORALE NOUVELLE DU CABAZITAXEL (NOVEL ANTITUMORAL USE OF CABAZITAXEL) | ⤷ Sign Up |
Yugoslavia | 49092 | ⤷ Sign Up | |
Mexico | 9306986 | COMPOSICIONES FARMACEUTICAS A BASE DE TAXOIDES. | ⤷ Sign Up |
Finland | 111807 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JEVTANA KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1667986 | 141 5019-2013 | Slovakia | ⤷ Sign Up | FIRST REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
1667986 | 122013000050 | Germany | ⤷ Sign Up | PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
1667986 | 13C0037 | France | ⤷ Sign Up | PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322 |
1667986 | C 2013 017 | Romania | ⤷ Sign Up | PRODUCT NAME: SOLVAT ACETONIC DE CABAZITAXEL; NATIONAL AUTHORISATION NUMBER: EU/1/11/676/001; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/676/001; DATE OF FIRST AUTHORISATION IN EEA: 20110317 |
1667986 | C20130017 00077 | Estonia | ⤷ Sign Up | PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011 |
1667986 | PA2013010,C1667986 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |