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Last Updated: November 29, 2022

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 two branded drugs marketed by Accord Hlthcare, Breckenridge, and Sanofi Aventis Us, and is included in three NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has ninety-eight patent family members in forty-six 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
Fundacion OncosurPhase 2
MacroGenicsPhase 2/Phase 3
Peter MacCallum Cancer Centre, AustraliaPhase 1/Phase 2

See all cabazitaxel clinical trials

Generic filers with tentative approvals for CABAZITAXEL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing60MG/1.5ML(40MG/ML)INJECTABLE;INJECTION
See Plans and PricingSee Plans and Pricing60MG/1.5ML (40MG/ML)SOLUTION;IV (INFUSION)
See Plans and PricingSee Plans and Pricing20MG/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 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 cabazitaxel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207949-001 Dec 29, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Breckenridge CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207619-001 Jun 23, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for cabazitaxel

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-aventis groupe  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 cabazitaxel

Country Patent Number Title Estimated Expiration
China 100429207 See Plans and Pricing
Luxembourg 92172 See Plans and Pricing
Portugal 1667986 See Plans and Pricing
Brazil PI0414492 solvato acetÈnico do dimetóxi docetaxel e seu processo de preparação See Plans and Pricing
Singapore 10201810928S NOVEL ANTITUMORAL USE OF CABAZITAXEL See Plans and Pricing
Colombia 6531492 NUEVO USO ANTITUMORAL DE CABAZITAXEL See Plans and Pricing
South Korea 20060072147 DIMETHOXY DOCETAXEL ACETONE SOLVATE AND METHOD FOR THE PREPARATION THEREOF See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cabazitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 SPC/GB13/042 United Kingdom See Plans and Pricing PRODUCT NAME: CABAZITAXEL IN THE FORM OF THE ACETONE SOLVATE; REGISTERED: UK EU/1/11/676/001 20110317
1667986 C01667986/01 Switzerland See Plans and Pricing PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: SWISSMEDIC 61543 06.04.2011
1667986 13C0037 France See Plans and Pricing PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322
1667986 1390025-3 Sweden See Plans and Pricing PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317
1667986 2013/021 Ireland See Plans and Pricing PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 CA 2013 00025 Denmark See Plans and Pricing
1667986 C20130017 00077 Estonia See Plans and Pricing PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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