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Cabazitaxel - Generic Drug Details
» See Plans and Pricing
What are the generic sources for cabazitaxel and what is the scope of freedom to operate?
Cabazitaxel
is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cabazitaxel has two hundred and fifteen patent family members in sixty-one countries.
There are thirteen drug master file entries for cabazitaxel. One supplier is listed for this compound. There are six tentative approvals for this compound.
Summary for cabazitaxel
| International Patents: | 215 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 117 |
| Patent Applications: | 2,218 |
| 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 |
|---|---|
| Astellas Pharma Europe Ltd. | Phase 2 |
| CHU de Quebec-Universite Laval | Phase 2 |
| University of Liverpool | Phase 2 |
Generic filers with tentative approvals for CABAZITAXEL
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 60MG/1.5ML(40MG/ML) | INJECTABLE;INJECTION |
| Start Trial | Start Trial | 60MG/1.5ML (40MG/ML) | SOLUTION;IV (INFUSION) |
| Start Trial | Start Trial | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| JEVTANA KIT | SOLUTION;INTRAVENOUS | cabazitaxel | 201023 | 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 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | Start Trial | Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | Start Trial | Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cabazitaxel
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 188987 | Start Trial |
| Croatia | P20130322 | Start Trial |
| Bulgaria | 63121 | Start Trial |
| Eurasian Patent Organization | 000567 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for cabazitaxel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1667986 | 122013000050 | Germany | Start Trial | PRODUCT NAME: ACETON-SOLVAT VON CABAZITAXEL; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
| 1667986 | 13C0037 | France | Start Trial | PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322 |
| 1667986 | 92172 | Luxembourg | Start Trial | 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) |
| 1667986 | C 2013 017 | Romania | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
