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ONIVYDE Drug Profile

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When do Onivyde patents expire, and what generic alternatives are available?

Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has sixty-two patent family members in twenty-three countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for ONIVYDE

International Patents:	62
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	65
Clinical Trials:	6
Patent Applications:	5,072
Formulation / Manufacturing:	see details
DailyMed Link:	ONIVYDE at DailyMed

Pharmacology for ONIVYDE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Synonyms for ONIVYDE

(+)-(4S)-4,11-Diethyl-4-hydroxy-9-<(piperidinopiperidino)-carbonyloxy>-1H-pyrano<3',4':6,7>indolizino<1,2-b>quinoline-3,14-(4H,12H)-dione hydrochloride trihydrate

(+)-7-Ethyl-10-hydroxycamptothecine 10-(1,4'-bipiperidine)-1'-carboxylate, monohydrochloride, trihydrate

(+)-Irinotecan

(1,4 inverted exclamation mark -bipiperidine)-1 inverted exclamation mark -carboxylicacid,4,11-diethyl-3,4,12,14-tetrahydro-4-hyd

(1,4'-Bipiperidine)-1'-carboxylic acid, (4S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl ester

(1,4'-Bipiperidine)-1'-carboxylic acid, 4,11-diethyl-3,4,12-14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl ester, (S)-

(1,4'-Bipiperidine)-1'-carboxylic acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl ester, monohydrochloride, trihydrate, (S)-

(1,4'-Bipiperidine)-1'-carboxylic acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl ester, monohydrochloride,trihydrate, (S)-

(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.0^{2,11}.0^{4,9}.0^{15,20}]henicosa-1(21),2,4,6,8,10,15(20)-heptaen-7-yl [1,4'-bipiperidine]-1'-carboxylate trihydrate hydrochloride

(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.0;{2,11}.0;{4,9}.0;{15,20}]henicosa-1(21),2(11),3,5,7,9,15(20)-heptaen-7-yl 4-(piperidin-1-yl)piperidine-1-carboxylate

(19S)-10,19-DIETHYL-19-HYDROXY-14,18-DIOXO-17-OXA-3,13-DIAZAPENTACYCLO[11.8.0.0(2),(1)(1).0?,?.0(1)?,(2)?]HENICOSA-1(21),2(11),3,5,7,9,15(20)-HEPTAEN-7-YL [1,4'-BIPIPERIDINE]-1'-CARBOXYLATE

(4S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate

(4S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate hydrochloride--water (1/3)

(4S)-4,11-DIETHYL-4-HYDROXY-3,14-DIOXO-3,4,12,14-TETRAHYDRO-1H-PYRANO[3',4':6,7]INDOLIZINO[1,2-B]QUINOLIN-9-YL 1,4'-BIPIPERIDINE-1'-CARBOXYLATE

(4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl 1,4'-bipiperidine-1'-carboxylate hydrochloride trihydrate

(4S)-4,11-DIETHYL-4-HYDROXY-3,14-DIOXO-3,4,12,14-TETRAHYDRO-1H-PYRANO[3'',4'':6,7]INDOLIZINO[1,2-B]QUINOLIN-9-YL 1,4''-BIPIPERIDINE-1''-CARBOXYLATE

(4S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-4,12-dihydro-1H-pyrano[3,4-f]quinolino[2,3-a]indolizin-9-yl 4-piperidylpiperidinecarboxylate

(diethyl-hydroxy-dioxo-[?]yl) 4-(1-piperidyl)piperidine-1-carboxylate

(s)-[1,4'-bipiperidine]-1'-carboxylic acid 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester hydrochloride trihydrate

(S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-Bipiperidine]-1'-carboxylate Hydrochloride Trihydrate

(S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate

[1,4'-Bipiperidine]-1'-carboxylic acid (4S)-4,11-Diethyl-3,4,12,14- tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester hydrochloride trihydrate

[1,4'-Bipiperidine]-1'-carboxylic acid (4S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester hydrochloride trihydrate

[1,4'-Bipiperidine]-1'-carboxylic acid, (4S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester

[1,4'']bipiperidinyl-1''-carboxylic acid (S)-4,11-diethyl-4-hydroxy-3,13-dioxo-3,4,12,13-tetrahydro-1H-2-oxa-6,12a-diaza-dibenzo[b,h]fluoren-9-yl ester

[1,4'']Bipiperidinyl-1''-carboxylic acid 4,11-diethyl-4-hydroxy-3,13-dioxo-3,4,12,13-tetrahydro-1H-2-oxa-6,12a-diaza-dibenzo[b,h]fluoren-9-yl ester

[1,4']Bipiperidinyl-1'-carboxylic acid (S)-4,11-diethyl-4-hydroxy-3,13-dioxo-3,4,12,13-tetrahydro-1H-2-oxa-6,12a-diaza-dibenzo[b,h]fluoren-9-yl ester

042LAQ1IIS

1-[1-({[(4S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl]oxy}carbonyl)piperidin-4-yl]piperidin-1-ium chloride--water (1/3)

1,4'-Bipiperidine-1'-carboxylic acid (S)-4,11-diethyl-3,4,12,14- tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester

100286-90-6 (anhyd.)

136572-09-3

1u65

572I093

682I445

97682-44-5

AB0014364

AB00698464_12

AB00698464_13

AB00698464_14

AB00698464-07

AB00698464-09

AB00698464-10

AB00698464-11

AB07527

ABP000494

AC-7469

AC-9034

AC1L1U0W

AC1L1U0Z

AC1Q3ESZ

AC1Q6PGI

AK-41625

AK163712

AKOS015894969

AKOS015967279

AN-7418

AN-8954

ANW-41679

AS-14323

BC202629

BCP9000793

BCP9000794

BDBM50128267

Bio-0054

Biotecan

Biotecan (TN)

BRD-K08547377-003-02-4

BSPBio_002346

BT000965

C16641

C33H38N4O6

C35H41N3O5.3H2O.HCl

Campto

Campto (TN)

Camptosar

Camptosar (TN)

Camptosar, Campto, CPT-11, Irinotecan

Camptosar.(R).

camptothecin-11

CCG-220690

CHEBI:80630

CHEBI:90881

CHEMBL481

CP0

CPT 11

CPT-11

CPT-11 Trihydrate

CS-1138

CS-1139

CTK8B3046

D01061

D07HOB

D08086

DB00762

DR003330

DS-2676

DTXSID1041051

EBD36403

FT-0083650

FT-0602416

FT-0627290

GP2560

GTPL6823

HSDB 7607

HY-16562

HY-16568

Irinophore C

irinotecan

Irinotecan (hydrochloride trihydrate)

Irinotecan (INN)

Irinotecan (TOPO1 inhibitor)

Irinotecan [INN:BAN]

Irinotecan Hcl

Irinotecan Hcl Trihydrate

Irinotecan HCl Trihydrate - Campto

Irinotecan HCl Trihydrate (Campto)

Irinotecan Hcl Trihydrate(Campto) /

Irinotecan hydrochloride (USAN)

Irinotecan hydrochloride [USAN:JAN]

Irinotecan hydrochloride [USAN:USP:JAN]

Irinotecan hydrochloride hydrate

Irinotecan hydrochloride hydrate (JAN)

IRINOTECAN HYDROCHLORIDE Trihydrate

Irinotecan HydrochlorideTrihydrate

Irinotecan lactone

irinotecan liposome

irinotecan liposome injection

IRINOTECAN MONOHYDROCHLORIDE TRIHYDRATE

Irinotecan mylan

IRINOTECAN, CPT-11

Irinotecanhydrochloridetrihydrate

Irinotecanum

Irinotecanum [INN-Latin]

K754

KLEAIHJJLUAXIQ-JDRGBKBRSA-N

KS-00000J9S

KS-00000NVX

LS-44589

LS-44590

MCULE-1702653278

MFCD00866307

MFCD01765731

MFCD01862255

MolPort-003-848-231

MolPort-005-933-077

MP-1700

NCGC00178697-02

NCGC00178697-05

NCI60_005051

NSC-728073

NSC728073

Onivyde (TN)

PL076309

product-irinotecan

PubChem13094

PubChem16441

PubChem16673

RL01622

roxy-3,14-dioxo-1h-pyrano(3 inverted exclamation mark ,4 inverted exclamation mark :6,7)indolizino(1,2-b)quinolin-9-ylester,mono

s1198

s2217

SC-17271

SC-19212

SCHEMBL4034

ST24030784

ST24047421

ST51053923

TL8006026

topotecin hydrochloride

TR-031973

trihydrate,(s)-hydrochlorid

U-101,440E

U-101440E

UNII-042LAQ1IIS

UNII-7673326042

UWKQSNNFCGGAFS-XIFFEERXSA-N

W-5141

ZINC1612996

US Patents and Regulatory Information for ONIVYDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;IV (INFUSION)	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;IV (INFUSION)	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;IV (INFUSION)	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;IV (INFUSION)	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for ONIVYDE

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
8,658,203	Liposomes useful for drug delivery to the brain
9,737,528	Liposomes useful for drug delivery to the brain
9,717,723	Liposomes useful for drug delivery

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International Patents for ONIVYDE

Country	Document Number	Estimated Expiration
China	103948545
Canada	2875824
Poland	1746976
Canada	2566007

Supplementary Protection Certificates for ONIVYDE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017 00030	Denmark		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
2017000042	Germany		PRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014
0885	Netherlands		PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
C/GB97/010	United Kingdom		PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017