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Last Updated: August 9, 2020

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Cabazitaxel - Generic Drug Details

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What are the generic sources for cabazitaxel and what is the scope of patent protection?

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

Cabazitaxel has two hundred and fourteen 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.

Recent Clinical Trials for cabazitaxel

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

SponsorPhase
ParexelPhase 2
Wake Forest University Health SciencesPhase 2
Barbara Ann Karmanos Cancer InstitutePhase 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 Y   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
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
>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
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 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 PA2013010 Lithuania   Start Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 2013/021 Ireland   Start Trial PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 122013000050 Germany   Start Trial PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Boehringer Ingelheim
McKinsey
Harvard Business School
Medtronic

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