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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Cabazitaxel - Generic Drug Details

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What are the generic sources for cabazitaxel and what is the scope of freedom to operate?

Cabazitaxel is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has two hundred and fifteen patent family members in sixty-one countries.

There are thirteen drug master file entries for cabazitaxel. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for cabazitaxel
Recent Clinical Trials for cabazitaxel

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Astellas Pharma Europe Ltd.Phase 2
CHU de Quebec-Universite LavalPhase 2
University of LiverpoolPhase 2

See all cabazitaxel clinical trials

Generic filers with tentative approvals for CABAZITAXEL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG/1.5ML(40MG/ML)INJECTABLE;INJECTION
  Start Trial  Start Trial60MG/1.5ML (40MG/ML)SOLUTION;IV (INFUSION)
  Start Trial  Start Trial20MG/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for CABAZITAXEL
Tradename Dosage Ingredient NDA Submissiondate
JEVTANA KIT SOLUTION;INTRAVENOUS cabazitaxel 201023 2014-06-17

US Patents and Regulatory Information for cabazitaxel

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 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 cabazitaxel

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   Start Trial   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010   Start Trial   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010   Start Trial   Start Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for cabazitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 122013000050 Germany   Start Trial PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 13C0037 France   Start Trial PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322
1667986 92172 Luxembourg   Start Trial PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
1667986 C 2013 017 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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