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
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

See all CABAZITAXEL clinical trials

Generic filers with tentative approvals for CABAZITAXEL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	UNKNOWN	UNKNOWN
⤷ Sign Up	⤷ Sign Up	20MG/ML	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	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.

Anatomical Therapeutic Chemical (ATC) Classes for CABAZITAXEL

L01CD	Taxanes
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	207693-001	Oct 26, 2022	AP	RX	No	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			Y	⤷ Sign Up
Mylan Labs Ltd	CABAZITAXEL	cabazitaxel	SOLUTION;INTRAVENOUS	207381-001	Jul 5, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Breckenridge	CABAZITAXEL	cabazitaxel	SOLUTION;INTRAVENOUS	207619-001	Jun 23, 2022		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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for CABAZITAXEL

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1667986	SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL ET SON PROCEDE DE PREPARATION (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF)	⤷ Sign Up
Uruguay	32987	NUEVO USO ANTITUMORAL DE CABAZITAXEL	⤷ Sign Up
Australia	2010310986	Novel antitumoral use of cabazitaxel	⤷ Sign Up
Serbia	20060189	ACETONSKI SOLVATI DIMETOKSI DOCETAKSELA I POSTUPCI ZA NJIHOVO DOBIJANJE (DIMETHOXY DOCETAXEL ACETONE SOLVATE ET METHOD FOR THE PREPARATION THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CABAZITAXEL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	92172	Luxembourg	⤷ Sign Up	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	2013/021	Ireland	⤷ Sign Up	PRODUCT NAME: CABAZITAXEL ACETONE SOLVATE; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	C20130017 00077	Estonia	⤷ Sign Up	PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011
1667986	C300595	Netherlands	⤷ Sign Up	PRODUCT NAME: CABAZITAXEL ACETONAAT; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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