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Cabazitaxel - Generic Drug Details

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What are the generic sources for cabazitaxel and what is the scope of cabazitaxel patent protection?

Cabazitaxel is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has two hundred and ten patent family members in fifty-nine 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:	210
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	13
Suppliers / Packagers:	1
Bulk Api Vendors:	46
Clinical Trials:	108
Patent Applications:	77
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabazitaxel
DailyMed Link:	cabazitaxel at DailyMed

Synonyms for cabazitaxel

(((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate1-hydroxy-7beta,10beta-dimethoxy-9-oxo-5beta,20-epoxytax-11-ene-2alpha,4,13alpha-triyl 4-acetate 2-benzoate 13-((2R,3S)-3-

(1S)-5beta,20-Epoxy-9-oxo-7beta,10beta-dimethoxytaxa-11-ene-1,2alpha,4alpha,13alpha-tetraol 2-benzoate 4-acetate 13-[(2R,3S)-2-hydroxy-3-(tert-butoxycarbonylamino)-3-phenylpropionate]

(2alpha,5beta,7beta,10beta,13alpha)-4-acetoxy-13-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate

(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-acetoxy-9-(((2R,3S)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a

1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-ene-2,4,13-triyl 4-acetate 2-benzoate 13-((2R,3S)-3-(((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate)

183133-96-2

4CA-0334

51F690397J

890654-44-1

A25044

AB01273971_02

AB01273971-01

ABP001072

AC-23876

ACN-052902

AK322514

AKOS025401630

AKOS026750532

AKOS027326867

AKOS032947285

AKOS032949632

AN-1492

AOB2597

BC252842

BCP27641

BMQGVNUXMIRLCK-OAGWZNDDSA-N

BP-23954

BRD-K06858286-001-01-3

C45H57NO14

Cabazitaxel (Jevtana)

Cabazitaxel (USAN/INN)

Cabazitaxel [USAN:INN]

Cabazitaxel Injection

Cabazitaxel-d6

Cabazitaxel; TXD-258

Cabazitaxelum

CHEBI:63584

CHEMBL1201748

CS-0972

CS-W004539

D09755

DB06772

DTXSID40171389

EX-A838

GTPL6798

HY-15459

J-011721

J-519981

Jevanta

Jevtana

Jevtana (TN)

Jevtana Kit

KS-00000PSA

MolPort-023-299-439

MolPort-042-624-416

NCGC00346704-01

NSC-761432

NSC761432

QC-10461

RPR 116258A

s3022

SC-94928

SCHEMBL15342039

SCHEMBL15492917

SCHEMBL15854556

SCHEMBL16234431

SCHEMBL179674

SR-01000941585

SR-01000941585-1

SW219050-1

Taxoid XRP6258

TXD 258

TXD 258-d6

TXD258

UNII-51F690397J

VA10453

W-5799

X7252

XRP 6258

XRP 6258-d6

XRP-6258

Xrp6258

ZINC85536932

Generic filers with tentative approvals for CABAZITAXEL

Applicant	Application No.	Strength	Dosage Form
		20MG/ML(60MG/3ML)	INJECTABLE;INJECTION
		60MG/6ML	INJECTABLE;INJECTION
		40MG/4ML	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.

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					Y
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010		RX	Yes	Yes
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010		RX	Yes	Yes					Y
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010		RX	Yes	Yes

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
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010

International Patents for cabazitaxel

Country	Patent Number	Estimated Expiration
Hungary	223732
Slovenia	1667986
Czech Republic	9703030
Mexico	9400806

Supplementary Protection Certificates for cabazitaxel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	141 5019-2013	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	PA2013010,C1667986	Lithuania		PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	2013C/036	Belgium		PRODUCT NAME: CABAZITAXEL; AUTHORISATION NUMBER AND DATE: EU/1/11/676/001 20110322
1667986	92172	Luxembourg		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)