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Generated: May 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 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, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Teva Pharms Usa, Sanofi Aventis Us, and Eagle Pharms, 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.

Docetaxel has nineteen patent family members in seventeen countries.

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

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

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
Accord Hlthcare DOCETAXEL docetaxel INJECTABLE;INJECTION 201195-005 Apr 20, 2012 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ingenus Pharms Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 207563-003 Aug 31, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Labs DOCETAXEL docetaxel INJECTABLE;INJECTION 202356-004 Mar 13, 2014 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jiangsu Hengrui Med DOCETAXEL docetaxel INJECTABLE;INJECTION 203170-001 Feb 15, 2017 RX No Yes ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for docetaxel

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 28/2013 Austria ➤ Sign Up PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
0253738 C960002 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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