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, 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207693-001 | Oct 26, 2022 | AP | RX | No | No | ⤷ 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 | ||||
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 | Y | ⤷ Try a Trial | ||
Accord Hlthcare | CABAZITAXEL | cabazitaxel | SOLUTION;INTRAVENOUS | 207949-001 | Dec 29, 2021 | RX | Yes | Yes | ⤷ 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 | |||
>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 |
---|---|---|---|
Ukraine | 110606 | НОВЕ ПРОТИПУХЛИННЕ ЗАСТОСУВАННЯ КАБАЗИТАКСЕЛУ (NEW ANTICANCER APPLICATION OF CABAZITAXEL) | ⤷ Try a Trial |
South Korea | 101123588 | ⤷ Try a Trial | |
Portugal | 1667986 | ⤷ Try a Trial | |
France | 2859996 | SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL ET SON PROCEDE DE PREPARATION (New well characterized, crystalline acetone solvate of dimethoxy docetaxel, useful as anticancer and antileukemia agent, obtained by crystallization of dimethoxy docetaxel from aqueous acetone) | ⤷ Try a Trial |
Japan | 6182510 | ⤷ Try a Trial | |
Guatemala | 201200123 | NUEVO USO ANTITUMORAL DE CABAZITAXEL | ⤷ Try a Trial |
Norway | 2015013 | ⤷ 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 | 28/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317 |
1667986 | C20130017 00077 | Estonia | ⤷ Try a Trial | PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011 |
1667986 | 2013C/036 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
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 | 636 | Finland | ⤷ Try a Trial | |
1667986 | PA2013010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: CABAZITAXELUM; 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |