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Last Updated: February 25, 2024

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, Apotex, Breckenridge, Dr Reddys, Mylan Labs Ltd, and Sanofi Aventis Us, and is included in seven NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has ninety-six 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 four 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
⤷  Try a Trial⤷  Try a TrialUNKNOWNUNKNOWN
⤷  Try a Trial⤷  Try a Trial20MG/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial40MG/4MLINJECTABLE;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
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207381-001 Jul 5, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex CABAZITAXEL cabazitaxel SOLUTION;INTRAVENOUS 207736-001 Feb 10, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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 Winthrop Industrie 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

Supplementary Protection Certificates for cabazitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 2013/021 Ireland ⤷  Try a Trial PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 PA2013010,C1667986 Lithuania ⤷  Try a Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 SPC/GB13/042 United Kingdom ⤷  Try a Trial PRODUCT NAME: CABAZITAXEL IN THE FORM OF THE ACETONE SOLVATE; REGISTERED: UK EU/1/11/676/001 20110317
1667986 13C0037 France ⤷  Try a Trial PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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