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.
Summary for cabazitaxel
| International Patents: | 98 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 124 |
| 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 |
|---|---|
| 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
| Applicant | Application No. | Strength | Dosage Form |
| See Plans and Pricing | See Plans and Pricing | 60MG/1.5ML(40MG/ML) | INJECTABLE;INJECTION |
| See Plans and Pricing | See Plans and Pricing | 60MG/1.5ML (40MG/ML) | SOLUTION;IV (INFUSION) |
| See Plans and Pricing | See Plans and Pricing | 20MG/ML | INJECTABLE;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
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 |
