CABAZITAXEL - Generic Drug Details
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What are the generic drug sources for cabazitaxel and what is the scope of patent protection?
Cabazitaxel
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis, Apotex, Breckenridge, Dr Reddys, Mylan Labs Ltd, and Sanofi Aventis Us, and is included in eight 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 three tentative approvals for this compound.
Summary for CABAZITAXEL
| International Patents: | 96 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 127 |
| Patent Applications: | 4,294 |
| 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 |
|---|---|
| Fundacion Oncosur | Phase 2 |
| MacroGenics | Phase 2/Phase 3 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207949-001 | Dec 29, 2021 | DISCN | Yes | 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 | ||
| Actavis | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207970-001 | Mar 14, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Labs Ltd | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207381-001 | Jul 5, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| Denmark | 1667986 | ⤷ Sign Up | |
| South Africa | 201203123 | ⤷ Sign Up | |
| Mexico | PA06002639 | SOLVATO ACETONICO DEL DIMETOXI DOCETAXEL Y SU PROCEDIMIENTO DE PREPARACION. (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF.) | ⤷ Sign Up |
| Slovenia | 1667986 | ⤷ Sign Up | |
| China | 1849311 | Acetone solvate of dimethoxy docetaxel and its process of preparation | ⤷ 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 | SPC/GB13/042 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CABAZITAXEL IN THE FORM OF THE ACETONE SOLVATE; REGISTERED: UK EU/1/11/676/001 20110317 |
| 1667986 | C01667986/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: SWISSMEDIC 61543 06.04.2011 |
| 1667986 | 13C0037 | France | ⤷ Sign Up | PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322 |
| 1667986 | 1390025-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317 |
| 1667986 | 2013/021 | Ireland | ⤷ Sign Up | PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
