Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

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Docetaxel - Generic Drug Details

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What are the generic sources for docetaxel and what is the scope of freedom to operate?

Docetaxel is the generic ingredient in three branded drugs marketed by Sun Pharma Global, Accord Hlthcare, Actavis Llc, Amneal Pharms Co, Apotex Inc, Cipla, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Shilpa Medicare Ltd, Teikoku Pharma, Teva Pharms Usa, and Sanofi Aventis Us, and is included in twenty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Docetaxel has twenty-one patent family members in eighteen countries.

There are forty-one drug master file entries for docetaxel. Fifteen suppliers are listed for this compound.

Drug Prices for docetaxel

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Recent Clinical Trials for docetaxel

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SponsorPhase
Shanghai Zhongshan HospitalPhase 1
Wake Forest University Health SciencesPhase 1
Tianjin Medical University Second HospitalPhase 2

See all docetaxel clinical trials

Recent Litigation for docetaxel

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District Court Litigation
Case NameDate
Shubh Hotels Pittsburgh, LLC2010-09-07
Aventis Pharma S.A. v. Sandoz Inc.2009-10-29
Aventis Pharma S.A. v. Apotex Inc.2008-08-08

See all docetaxel litigation

Pharmacology for docetaxel
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Synonyms for docetaxel
(2alpha,5beta,7beta,10beta,13alpha)-4-(acetyloxy)-13-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7,10-trihydroxy-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)-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10
(2beta,5beta,7alpha,8alpha,10alpha,13alpha)-4-(acetyloxy)-13-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7,10-trihydroxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate
[acetoxy-[(2R,3S)-3-(tert-butoxycarbonylamino)-2-hydroxy-3-phenyl-propanoyl]oxy-trihydroxy-tetramethyl-oxo-[?]yl] benzoate
114977-28-5
114977-28-5, Docetaxel
129522-72-1
216252-50-5
4-(acetyloxy)-13alpha-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1,7beta,10beta-trihydroxy-9-oxo-5beta,20-epoxytax-11-en-2alpha-yl benzoate
5?,20-Epoxy-1,7?,10?-trihydroxy-9-oxotax-11-ene-2?,4,13?-triyl 4-acetate 2-benzoate 13-[(2R,3S)-3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate]
699121PHCA
AB0072965
AB01273941-01
AB01273941-02
AC-383
AC1L3WHJ
AK-72918
AKOS015960718
AKOS024457953
Anhydrous Docetaxel, European Pharmacopoeia (EP) Reference Standard
ANX-514
BC204088
BDBM36351
bind-014
BRD-K30577245-001-04-3
BRD-K30577245-341-01-9
C11231
CAS-114977-28-5
CD-195
CD0182
CHEBI:4672
CHEMBL92
CID148124
CS-1144
D07866
D4102
DB01248
Docecad
Docefrez
Docetaxel - Taxotere
Docetaxel (JAN/INN)
Docetaxel (TN)
Docetaxel [INN]
docetaxel 114977-28-5
Docetaxel anhydrous
Docetaxel Winthrop
Docetaxel, 98%
Docetaxel, purum, >=97.0% (HPLC)
Docetaxel, Trihydrate
Docetaxol
Docetaxolum
Docetaxolum [INN-Latin]
DSSTox_CID_20464
DSSTox_GSID_40464
DSSTox_RID_79497
DTXSID0040464
EmDOC
EX-A1206
GTPL6809
HMS2089K08
HSDB 6965
HY-B0011
KS-1452
MCULE-1930158681
MFCD00800737
MolPort-003-847-005
N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetylpaclitaxel
N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol
N-debenzoyl-N-Boc-10-deacetyl taxol
N-debenzoyl-N-tert-butoxycarbonyl-10-deacetyl taxol; Taxotere
N-debenzoyl-N-tert-butoxycarbonyl-10-deacetyltaxol
NCGC00181306-01
NCGC00181306-02
NCGC00181306-04
NCGC00242509-01
NSC 628503
NSC-628503
NSC628503
Q-100074
RL00579
RP 56976
RP-56976
SC-16998
SCHEMBL4419
SDP-014
SID 530
SR-01000003023
SR-01000003023-5
SYP-0704A
Taxoel
Taxotere
Taxotere (Aventis)
Taxotere (TN)
Taxotere(R)
Taxotere®
Tox21_112781
Tox21_112781_1
Tox21_113088
TXL
UNII-699121PHCA
W-1428
W-60384
XRP-6976L
XRP6976
Z1551429742
ZDZOTLJHXYCWBA-VCVYQWHSSA-
ZDZOTLJHXYCWBA-VCVYQWHSSA-N
ZINC85537053
Paragraph IV (Patent) Challenges for DOCETAXEL
Tradename Dosage Ingredient NDA Submissiondate
TAXOTERE INJECTABLE;INJECTION docetaxel 020449 2009-06-30

US Patents and Regulatory Information for docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 204193-001 Nov 5, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-001 Mar 8, 2011 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Teikoku Pharma DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-002 Dec 22, 2015 AP RX No No   Start Trial   Start Trial   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 docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010   Start Trial   Start Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for docetaxel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 28/2013 Austria   Start Trial PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986 92172 Luxembourg   Start 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)
0253738 C960002 Netherlands   Start Trial PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.