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Generated: November 16, 2018

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Docetaxel - Generic Drug Details

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What are the generic drug sources for docetaxel and what is the scope of docetaxel 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 Ltd, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Eagle Pharms, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Teva Pharms Usa, and Sanofi Aventis Us, and is included in twenty NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for docetaxel
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Synonyms for docetaxel
(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(acetyloxy)-15-{[(2R,3S)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1,9,12-trihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^{3,10}.0^{4,7}]heptadec-13
(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(acetyloxy)-15-{[(2R,3S)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1,9,12-trihydroxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0;{3,10}.0;{4,7}]heptadec-13
(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(ACETYLOXY)-15-{[(2R,3S)-3-{[(TERT-BUTOXY)CARBONYL]AMINO}-2-HYDROXY-3-PHENYLPROPANOYL]OXY}-1,9,12-TRIHYDROXY-10,14,17,17-TETRAMETHYL-11-OXO-6-OXATETRACYCLO[11.3.1.0(3),(1)?.0?,?]HEPTADEC-13-E
(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-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl (aR,bS)-b-[[(
(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
(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,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-
[2aR-[2a?,4?,4a?,6?,9?(?R*,?S*),11?,12?,12a?,12b?]]-?-[[(1,1-Dimethylethoxy)carbonyl]amino]-?-hydroxy-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo
[acetoxy-[(2R,3S)-3-(tert-butoxycarbonylamino)-2-hydroxy-3-phenyl-propanoyl]oxy-trihydroxy-tetramethyl-oxo-[?]yl] benzoate
1,8-Di-p-toluidinoanthraquinone
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
AM012960
Anhydrous Docetaxel, European Pharmacopoeia (EP) Reference Standard
ANX-514
BC204088
BDBM36351
Benzenepropanoic acid, beta-(((1,1-dimethylethoxy)carbonyl)amino)-alpha-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-
Benzenepropanoic acid, beta-(((1,1-dimethylethoxy)carbonyl)amino)-alpha-hydroxy-, 12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyc
Benzenepropanoic acid,1-dimethylethoxy)carbonyl]amino]-.alpha.-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(acetyloxy)-12-(benzyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethy
bind-014
BT001095
C11231
CAS-114977-28-5
CD-195
CD0182
CHEBI:4672
CHEMBL92
CID148124
CS-1144
D07866
D0O5WP
D4102
DB01248
Docecad
Docefrez
Docetaxel - Taxotere
Docetaxel (INN)
Docetaxel (JAN/INN)
Docetaxel (TN)
Docetaxel [INN]
docetaxel 114977-28-5
Docetaxel anhydrous
Docetaxel Winthrop
Docetaxel, purum, >=97.0% (HPLC)
Docetaxel, Trihydrate
Docetaxol
Docetaxolum
Docetaxolum [INN-Latin]
docetere
DSSTox_CID_20464
DSSTox_GSID_40464
DSSTox_RID_79497
DTXSID0040464
EmDOC
EX-A1206
GTPL6809
HMS2089K08
HSDB 6965
HY-B0011
InChI=1/C43H53NO14/c1-22-26(55-37(51)32(48)30(24-15-11-9-12-16-24)44-38(52)58-39(3,4)5)20-43(53)35(56-36(50)25-17-13-10-14-18-25)33-41(8,34(49)31(47)29(22)40(43,6)7)27(46)19-28-42(33,21-54-28)57-23(2)45/h9-18,26-28,30-33,35,4
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
PL019153
Q-100074
RL00579
RP 56976
RP-56976
SC-16998
SCHEMBL4419
SDP-014
SID 530
SYP-0704A
Taxoel
taxotel
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

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
Jiangsu Hengrui Med DOCETAXEL docetaxel INJECTABLE;INJECTION 203170-001 Feb 15, 2017 RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 208859-001 Apr 30, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-001 Mar 13, 2014 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz DOCETAXEL docetaxel INJECTABLE;INJECTION 201525-003 Jun 29, 2011 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms Co DOCETAXEL docetaxel INJECTABLE;INJECTION 209640-003 Jan 19, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-002 Mar 13, 2014 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

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Expired US Patents for docetaxel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for docetaxel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2013 Austria ➤ Sign Up PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
172 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)
60002 Netherlands ➤ Sign Up PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Daiichi Sankyo
Covington
Chinese Patent Office
Cantor Fitzgerald
Fish and Richardson
QuintilesIMS
US Department of Justice

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.