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Paclitaxel - Generic Drug Details

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

Paclitaxel is the generic ingredient in four branded drugs marketed by Abraxis Bioscience, Gland Pharma Ltd, Accord Hlthcare, Actavis Totowa, Fresenius Kabi Oncol, Hospira, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, West-ward Pharms Int, and Hq Spclt Pharma, and is included in sixteen NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixty-nine drug master file entries for paclitaxel. Twelve suppliers are listed for this compound.

Summary for paclitaxel

US Patents:	12
Tradenames:	4
Applicants:	14
NDAs:	16
Drug Master File Entries:	69
Suppliers / Packagers:	12
Bulk Api Vendors:	70
Clinical Trials:	2,516
Patent Applications:	7,568
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for paclitaxel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paclitaxel
DailyMed Link:	paclitaxel at DailyMed

Pharmacology for paclitaxel

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for paclitaxel

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Synonyms for paclitaxel

(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-bis(acetyloxy)-1,9-dihydroxy-15-{[(2R,3S)-2-hydroxy-3-phenyl-3-(phenylformamido)propanoyl]oxy}-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^{3,10}.0^{4,7}]heptadec-13-en-2-yl be
(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-bis(acetyloxy)-1,9-dihydroxy-15-{[(2R,3S)-2-hydroxy-3-phenyl-3-(phenylformamido)propanoyl]oxy}-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0;{3,10}.0;{4,7}]heptadec-13-en-2-yl be
(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4,12-BIS(ACETYLOXY)-1,9-DIHYDROXY-15-{[(2R,3S)-2-HYDROXY-3-PHENYL-3-(PHENYLFORMAMIDO)PROPANOYL]OXY}-10,14,17,17-TETRAMETHYL-11-OXO-6-OXATETRACYCLO[11.3.1.0(3),(1)?.0?,?]HEPTADEC-13-EN-2-YL BENZ
(2alpha,5beta,7beta,10beta,13alpha)-4,10-bis(acetyloxy)-1,7-dihydroxy-13-({(2R,3S)-2-hydroxy-3-phenyl-3-[(phenylcarbonyl)amino]propanoyl}oxy)-9-oxo-5,20-epoxytax-11-en-2-yl benzoate
(2aR-(2aalpha,4beta,4abeta,6beta,9alpha(alpha R,betaS),11alpha,12alpha,12balpha))-beta-(Benzoylamino)-alpha-hydroxybenzenepropanoic acid 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12
(2aR-(2aalpha,4beta,4abeta,6beta,9alpha(alpha R,betaS),11alpha,12alpha,12balpha))-beta-(Benzoylamino)-alpha-hydroxybenzenepropanoic acid 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro 4,6,9,11,12,12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano 5Hcyclodeca(3,4)benz(1,2-b)oxet-5-one 6,12b-diacetate,
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4,6,9,11,12,12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca(3,4)benz(1,2-b)oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester wi
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-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)-9-(((2R,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyl)oxy)-12-(benzoyloxy)-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-methanocyclodeca[3
(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-9-(((2R,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyl)oxy)-12-(benzoyloxy)-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-3,4,4a,5,6,9,10,11,12,12a-decahydro-1H-7,11-methanocyclodeca[3,4]benzo[
(NAB)-Paclitaxel
[diacetoxy-[(2R,3S)-3-benzamido-2-hydroxy-3-phenyl-propanoyl]oxy-dihydroxy-tetramethyl-oxo-[?]yl] benzoate
069P624
10337-EP2269989A1
10337-EP2270018A1
10337-EP2272827A1
10337-EP2272832A1
10337-EP2277507A1
10337-EP2277865A1
10337-EP2277876A1
10337-EP2280012A2
10337-EP2280014A2
10337-EP2281815A1
10337-EP2281820A2
10337-EP2286795A1
10337-EP2287168A2
10337-EP2289876A1
10337-EP2289892A1
10337-EP2292233A2
10337-EP2292234A1
10337-EP2292614A1
10337-EP2292615A1
10337-EP2295412A1
10337-EP2295413A1
10337-EP2295416A2
10337-EP2298748A2
10337-EP2298754A1
10337-EP2298772A1
10337-EP2298780A1
10337-EP2301533A1
10337-EP2301536A1
10337-EP2301538A1
10337-EP2301928A1
10337-EP2301933A1
10337-EP2301940A1
10337-EP2302382A2
10337-EP2302383A2
10337-EP2305243A1
10337-EP2305250A1
10337-EP2305640A2
10337-EP2305642A2
10337-EP2305671A1
10337-EP2305679A1
10337-EP2305689A1
10337-EP2305808A1
10337-EP2308833A2
10337-EP2308839A1
10337-EP2308861A1
10337-EP2311455A1
10337-EP2311808A1
10337-EP2311827A1
10337-EP2311829A1
10337-EP2314295A1
10337-EP2314574A1
10337-EP2316452A1
10337-EP2316832A1
10337-EP2316833A1
12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
1203669-79-7
157069-30-2
33069-62-4
4alpha,10beta-bis(acetyloxy)-13alpha-[(2S,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyloxy]-1,7beta-dihydroxy-9-oxo-5beta,20-epoxytax-11-en-2alpha-yl benzoate
5?,20-Epoxy-1,7?-dihydroxy-9-oxotax-11-ene-2?,4,10?,13?-tetrayl 4,10-diacetate 2-benzoate 13-[(2R,3S)-3-(benzoylamino)-2-hydroxy-3-phenylpropanoate]
5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
7-epi-Paclitaxel
7,11-Methano-1H-cyclodeca[3,4]benz[1,2-b]oxete, benzenepropanoic acid deriv.
7,11-METHANO-5H-CYCLODECA[3,4]BENZ[1,2-B]OXETE BENZENEPROPANOIC ACID DERIV.
7,4]benz[1,2-b]oxete,benzenepropanoic acid deriv.
AB00513812
AB00513812-02
AB00513812-03
AB0069184
ABI 007
ABI-007
ABP000252
Abraxane
Abraxane (albumin-bound suspension)
Abraxane (TN)
Abraxane I.V. Suspension
AC1L1VJI
ACN-032459
ACon1_002231
ACT02709
AK108391
AKOS007930675
AKOS015969673
AKOS025312303
AM022415
ANX-513
Anzatax
BDBM50001839
Benzenepropanoic acid, 6,12b-bis(acetyl oxy)-12-(benzoyloxy)- 2a,3,4,4a,5,6,9,10,11,12,12a,12b,- dodecahydro-4,11- dihydroxy-4a,8,13,13-tetramethyl-5-oxo- 7,11-methano- 1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester, [2aR- [2a.a
Benzenepropanoic acid, b-(benzoylamino)-.alpha.-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11
Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13
Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,1
Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H
Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca(3,4)benz(1,2-b
BIDD:PXR0046
Bio-0076
BMS 181339-01
BMS-181339
BMS-181339-01
BPBio1_000320
BRD-K62008436-001-03-1
BSPBio_000290
Capxol
CAS-33069-62-4
CCG-220155
CCRIS 8143
CHEBI:45863
CHEMBL428647
cMAP_000068
Coroflex Please
CS-1145
Cyclopax
Cynviloq
Cypher select
D00491
DB01229
DHP 107
DHP-107
DHP-208
DRG-0190
DSSTox_CID_3413
DSSTox_GSID_23413
DSSTox_RID_77016
DTS-301
DTXSID9023413
Ebetaxel
EmPAC
EndoTAG 1
EndoTAG-1
Genaxol
Genetaxyl
Genexol
Genexol-PM
GS-6554
GTPL2770
HMS2090D07
HMS2095O12
HMS2231A16
HSDB 6839
HY-B0015
IG 001
Infinnium
Intaxel
KBio2_002509
KBio2_005077
KBio2_007645
KBio3_002987
KBioGR_002509
KBioSS_002517
LEP-ETU
LipoPac
Liposome-entrapped paclitaxel easy-to-use
M-8858
MBT 0206
MEGxp0_001940
MFCD00869953
Mitotax
MLS002154218
MLS002695976
MolPort-001-742-627
MPI-5018
N1361
N88686
NA090030
nab-paclitaxel
nabpaclitaxel
Nanoparticle albumin bound paclitaxel
Nanotaxel
Nanoxel
NCGC00164367-01
NCGC00164367-02
NCGC00164367-03
NCGC00164367-04
NCGC00164367-05
NCI60_000601
NK 105
Nova-12005
NP-010981
NSC 125973
NSC-125973
NSC-745099
NSC125973
NSC745099
OAS-PAC-100
OncoGel
Onxal
Onxol
P-SSMM-VIP
P88XT4IS4D
Paclical
Pacliex
Pacligel
Paclitaxel (JAN/USP/INN)
Paclitaxel (Taxol)
Paclitaxel [USAN:USP:INN:BAN]
Paclitaxel natural for peak identification, European Pharmacopoeia (EP) Reference Standard
Paclitaxel semi-synthetic for peak identification, European Pharmacopoeia (EP) Reference Standard
Paclitaxel semi-synthetic for system suitability, European Pharmacopoeia (EP) Reference Standard
Paclitaxel-SSMM-VIP
Paclitaxel, Antibiotic for Culture Media Use Only
Paclitaxel, European Pharmacopoeia (EP) Reference Standard
Paclitaxel, from semisynthetic (from Taxus sp.), >=97%
Paclitaxel, from Taxus brevifolia, >=95% (HPLC), powder
Paclitaxel, From Taxus brevifolia, 95%
Paclitaxel, from Taxus yannanensis, powder
Paclitaxel, pharmaceutical secondary standard; traceable to USP, PhEur
Paclitaxel, United States Pharmacopeia (USP) Reference Standard
Paclitaxel/
Padexol
Paxceed
Paxene
Paxoral
PL002062
Plaxicel
Prestwick3_000155
Q-201533
QW 8184
RCINICONZNJXQF-MZXODVADSA-N
RL03195
SCHEMBL3976
SDP-013
Sindaxel
SMR000857385
SR-01000075350
SR-01000075350-9
ST2419771
SY016928
Tax-11-en-9-one, 5beta,20-epoxy-1,2alpha,4,7beta,10beta,13alpha- hexahydroxy-, 4,10-diacetate 2-benzoate, 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine (8CI)
Tax-11-en-9-one, 5beta,20-epoxy-1,2alpha,4,7beta,10beta,13alpha-hexahydroxy-, 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine (8CI)
Tax-11-en-9-one,20-epoxy-1,2.alpha.,4,7.beta., 10.beta.,13.alpha.- hexahydroxy-, 4,10-diacetate 2- benzoate,13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
TaxAlbin
TAXOL
TAXOL (TN)
Taxol (TN) (Bristol Meyers)
Taxol A
Taxus Express
Taxus Liberte
Taxus stent
Tocosol Paclitaxel
Tox21_112107
UNII-P88XT4IS4D
Vascular Wrap
Xorane
Yewtaxan
ZINC96006020
Zisu
ZX-AFC000078

US Patents and Regulatory Information for paclitaxel

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Accord Hlthcare	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	205720-001	Aug 17, 2018	AP	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	AP	RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Hospira	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	076233-001	Aug 1, 2002		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	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

Expired US Patents for paclitaxel

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for paclitaxel

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Country	Document Number	Estimated Expiration
New Zealand	525580	➤ Sign Up
Australia	718753	➤ Sign Up
Turkey	200502189	➤ Sign Up
Hungary	230338	➤ Sign Up
Russian Federation	2009121568	➤ Sign Up
Russian Federation	2013149282	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for paclitaxel

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0050	France	➤ Sign Up	PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
613	Luxembourg	➤ Sign Up	91613, EXPIRES: 20220924
00673	Netherlands	➤ Sign Up	PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
2014 00034	Denmark	➤ Sign Up	PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220
2009 00036	Denmark	➤ Sign Up	PRODUCT NAME: PACLITAXELALBUMIN
0673	Netherlands	➤ Sign Up	PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description