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Paclitaxel - Generic Drug Details

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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 fifteen NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paclitaxel has two hundred and eighty-five patent family members in thirty-one countries.

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

Summary for paclitaxel

International Patents:	285
US Patents:	12
Tradenames:	4
Applicants:	14
NDAs:	15
Drug Master File Entries:	69
Suppliers / Packagers:	13
Bulk Api Vendors:	70
Clinical Trials:	2,390
Patent Applications:	7,579
Formulation / Manufacturing:	see details
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West-ward Pharms Int	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075190-001	Jan 28, 2002	AP	RX	No	No
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes			Y
Mylan	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075278-001	Jan 25, 2002		DISCN	No	No
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005		RX	Yes	Yes			Y

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Expired US Patents for paclitaxel

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
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005
Abraxis Bioscience	ABRAXANE	paclitaxel	FOR SUSPENSION;IV (INFUSION)	021660-001	Jan 7, 2005

Non-Orange Book US Patents for paclitaxel

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
8,846,771	Compositions and methods of delivery of pharmacological agents
9,012,518	Compositions and methods of delivery of pharmacological agents
9,012,519	Compositions and methods of delivery of pharmacological agents
7,780,984	Methods and compositions for treating proliferative diseases

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International Patents for paclitaxel

Country	Document Number	Estimated Expiration
European Patent Office	1178786
Russian Federation	2009110382
South Korea	20120068035
South Korea	20150065957

Supplementary Protection Certificates for paclitaxel

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
0673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111