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ONIVYDE Drug Profile

When do Onivyde patents expire, and when can generic versions of Onivyde launch?

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:	75
Clinical Trials:	14
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ONIVYDE
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;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ipsen Inc	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for ONIVYDE

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Country	Document Number	Estimated Expiration
Mexico	2014015391	➤ Sign Up
Japan	2012092119	➤ Sign Up
Canada	2928387	➤ Sign Up
South Korea	20170104638	➤ Sign Up
Ukraine	86063	➤ Sign Up
South Korea	20120082039	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ONIVYDE

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

Summary for ONIVYDE

Pharmacology for ONIVYDE

Synonyms for ONIVYDE

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