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Last Updated: January 29, 2022

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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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has two hundred and nineteen 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 five 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
⤷  Try it Free⤷  Try it Free60MG/1.5ML(40MG/ML)INJECTABLE;INJECTION
⤷  Try it Free⤷  Try it Free60MG/1.5ML (40MG/ML)SOLUTION;IV (INFUSION)
⤷  Try it Free⤷  Try it Free20MG/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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try it Free ⤷  Try it Free
>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 C20130017 00077 Estonia ⤷  Try it Free PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011
1667986 28/2013 Austria ⤷  Try it Free PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 C01667986/01 Switzerland ⤷  Try it Free PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: SWISSMEDIC 61543 06.04.2011
1667986 636 Finland ⤷  Try it Free
1667986 C300595 Netherlands ⤷  Try it Free PRODUCT NAME: CABAZITAXEL ACETONAAT; 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:

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Harvard Business School
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