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ONIVYDE Drug Profile

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:	134
Clinical Trials:	6
Patent Applications:	3,679
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	ONIVYDE at DailyMed

Drug patent expirations by year for ONIVYDE

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

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

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.

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Patent No.	Title	Estimated Patent Expiration
9,737,528	Liposomes useful for drug delivery to the brain	➤ Try a Free Trial
8,658,203	Liposomes useful for drug delivery to the brain	➤ Try a Free Trial
9,717,723	Liposomes useful for drug delivery	➤ Try a Free Trial
Patent No.	Title	Estimated Patent Expiration

International Patents for ONIVYDE

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Country	Document Number	Estimated Expiration
Canada	2928387	➤ Try a Free Trial
Russian Federation	2015155368	➤ Try a Free Trial
Slovenia	2861210	➤ Try a Free Trial
Poland	2861210	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ONIVYDE

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB97/010	United Kingdom	➤ Try a Free Trial	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
0885	Netherlands	➤ Try a Free Trial	PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
2017 00030	Denmark	➤ Try a Free Trial	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	➤ Try a Free Trial	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for ONIVYDE

Pharmacology for ONIVYDE

Synonyms for ONIVYDE

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