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, 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 three tentative approvals for this compound.
Summary for CABAZITAXEL
International Patents: | 96 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 126 |
Patent Applications: | 5,303 |
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 |
⤷ Try a Trial | ⤷ Try a Trial | UNKNOWN | UNKNOWN |
⤷ Try a Trial | ⤷ Try a Trial | 20MG/ML | INJECTABLE;INJECTION |
⤷ Try a Trial | ⤷ Try a Trial | 60MG/6ML (10MG/ML) | SOLUTION;INTRAVENOUS |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207736-001 | Feb 10, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207718-001 | Feb 10, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207693-001 | Oct 26, 2022 | AP | RX | No | No | ⤷ 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 | |||
Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | |||
Breckenridge | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207619-001 | Jun 23, 2022 | 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 |
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 |
International Patents for CABAZITAXEL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2015200149 | Novel antitumoral use of cabazitaxel | ⤷ Try a Trial |
Australia | 2016200598 | NOVEL ANTITUMORAL USE OF CABAZITAXEL | ⤷ Try a Trial |
Taiwan | I654975 | ⤷ Try a Trial | |
European Patent Office | 1667986 | SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL ET SON PROCEDE DE PREPARATION (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF) | ⤷ Try a Trial |
China | 106309452 | 卡巴他赛的新颖抗肿瘤用途 (Novel antitumoral use of cabazitaxel) | ⤷ Try a Trial |
Serbia | 54614 | ACETONSKI SOLVAT DIMETOKSI DOCETAKSELA I POSTUPAK ZA NJEGOVO DOBIJANJE (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF) | ⤷ Try a Trial |
Taiwan | 201611831 | Novel antitumoral use of CABAZITAXEL | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CABAZITAXEL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1667986 | CA 2013 00025 | Denmark | ⤷ Try a Trial | |
1667986 | C300595 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CABAZITAXEL ACETONAAT; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
1667986 | C 2013 017 | Romania | ⤷ Try a 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 |
1667986 | 92172 | Luxembourg | ⤷ Try a 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 | 2013C/036 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
1667986 | PA2013010,C1667986 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
1667986 | 1390025-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |