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Last Updated: December 14, 2019

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Cabazitaxel - Generic Drug Details

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What are the generic drug 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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabazitaxel has two hundred and eleven 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 six tentative approvals for this compound.

Recent Clinical Trials for cabazitaxel

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laekna LimitedPhase 1/Phase 2
Masonic Cancer Center, University of MinnesotaPhase 2
Radboud UniversityPhase 4

See all cabazitaxel clinical trials

Recent Litigation for cabazitaxel

Identify potential future generic entrants

District Court Litigation
Case NameDate
CELGENE CORPORATION v. HETERO LABS LIMITED2017-05-11
CELGENE CORPORATION v. PAR PHARMACEUTICAL, INC.2017-05-04
SANOFI-AVENTIS U.S. LLC v. APOTEX CORP.2015-01-14

See all cabazitaxel litigation

PTAB Litigation
PetitionerDate
Neptune Generics, LLC2018-10-31
Mylan Laboratories Limited2016-03-15
Mylan Laboratories Limited2016-02-17

See all cabazitaxel litigation

Generic filers with tentative approvals for CABAZITAXEL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial60MG/1.5ML(40MG/ML)INJECTABLE;INJECTION
  Start Trial  Start Trial60MG/1.5ML (40MG/ML)SOLUTION;IV (INFUSION)
  Start Trial  Start Trial20MG/MLINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
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 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
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
>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
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

Supplementary Protection Certificates for cabazitaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 CA 2013 00025 Denmark   Start Trial
1667986 PA2013010 Lithuania   Start Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 PA2013010,C1667986 Lithuania   Start Trial PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Harvard Business School
Colorcon
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.