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 two branded drugs marketed by Accord Hlthcare, Breckenridge, and Sanofi Aventis Us, and is included in four 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 two tentative approvals for this compound.
Summary for cabazitaxel
| International Patents: | 96 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 126 |
| Patent Applications: | 7,411 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cabazitaxel |
| What excipients (inactive ingredients) are in cabazitaxel? | cabazitaxel excipients list |
| DailyMed Link: | cabazitaxel at DailyMed |
Recent Clinical Trials for cabazitaxel
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MacroGenics | Phase 2/Phase 3 |
| Fundacion Oncosur | Phase 2 |
| Peter MacCallum Cancer Centre, Australia | Phase 1/Phase 2 |
Generic filers with tentative approvals for CABAZITAXEL
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for cabazitaxel
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207693-001 | Oct 26, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
International Patents for cabazitaxel
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I654975 | ⤷ Sign Up | |
| Singapore | 10201810928S | NOVEL ANTITUMORAL USE OF CABAZITAXEL | ⤷ Sign Up |
| Panama | 8612401 | SOLVATO ACETONICO DEL DIMETOXI DOCETAXEL Y SU PROCEDIMIENTO DE PREPARACION | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005028462 | ⤷ Sign Up | |
| European Patent Office | 1667986 | SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL ET SON PROCEDE DE PREPARATION (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cabazitaxel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1667986 | PA2013010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
| 1667986 | 2013C/036 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| 1667986 | PA2013010,C1667986 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
| 1667986 | C 2013 017 | Romania | ⤷ Sign Up | PRODUCT NAME: SOLVAT ACETONIC DE CABAZITAXEL; NATIONAL AUTHORISATION NUMBER: EU/1/11/676/001; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/676/001; DATE OF FIRST AUTHORISATION IN EEA: 20110317 |
| 1667986 | 92172 | Luxembourg | ⤷ Sign Up | 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) |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
