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AstraZeneca
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Johnson and Johnson
Covington
McKesson
Medtronic
Moodys

Generated: July 19, 2018

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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, 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 nineteen 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 sixteen patent family members in sixteen countries.

There are forty drug master file entries for docetaxel. Seventeen 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
Dfb Oncology Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 206177-002 Jan 20, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira Inc DOCETAXEL docetaxel INJECTABLE;INJECTION 022234-005 Jun 23, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd DOCETAXEL docetaxel INJECTABLE;INJECTION 204193-002 Nov 5, 2014 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Llc DOCETAXEL docetaxel INJECTABLE;INJECTION 203551-002 Apr 12, 2013 AP RX 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 020449-004 Aug 2, 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 020449-001 May 14, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for DOCETAXEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,763,880 Non-aqueous taxane formulations and methods of using the same ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for DOCETAXEL

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

Deloitte
Daiichi Sankyo
Federal Trade Commission
Accenture
Medtronic
Cantor Fitzgerald
Julphar
Citi
McKinsey

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