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Last Updated: November 28, 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 eighteen 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
Coherent Biopharma (Suzhou) Co., Ltd.Phase 1
Sun Yat-sen UniversityPhase 2
Wake Forest University Health SciencesPhase 2

See all CABAZITAXEL clinical trials

Generic filers with tentative approvals for CABAZITAXEL
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial60MG/1.5ML(40MG/ML)INJECTABLE;INJECTION
⤷  Free Forever Trial⤷  Free Forever Trial60MG/1.5ML (40MG/ML)SOLUTION;IV (INFUSION)
⤷  Free Forever Trial⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Free Forever Trial ⤷  Free Forever 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 PA2013010 Lithuania ⤷  Free Forever Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 PA2013010,C1667986 Lithuania ⤷  Free Forever Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 SPC/GB13/042 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: CABAZITAXEL IN THE FORM OF THE ACETONE SOLVATE; REGISTERED: UK EU/1/11/676/001 20110317
1667986 CA 2013 00025 Denmark ⤷  Free Forever Trial
1667986 141 5019-2013 Slovakia ⤷  Free Forever Trial FIRST 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:

Colorcon
McKinsey
AstraZeneca
Mallinckrodt
Merck
Express Scripts

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