Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Cerilliant
US Department of Justice
Chinese Patent Office
Citi
UBS
Johnson and Johnson
Healthtrust

Generated: June 19, 2018

DrugPatentWatch Database Preview

IRINOTECAN HYDROCHLORIDE - Generic Drug Details

or, see our see our flat-rate plans

« Back to Dashboard

What are the generic drug sources for irinotecan hydrochloride and what is the scope of irinotecan hydrochloride patent protection?

Irinotecan hydrochloride
is the generic ingredient in three branded drugs marketed by Ipsen Inc, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Ingenus Pharms Llc, Intas Pharms Usa, Jiangsu Hengrui Med, Mustafa Nevzat Ilac, Pliva Lachema, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty-five NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has sixty-four patent family members in twenty-three countries.

There are thirty-three drug master file entries for irinotecan hydrochloride. Seventeen suppliers are listed for this compound.
Summary for IRINOTECAN HYDROCHLORIDE
Pharmacology for IRINOTECAN HYDROCHLORIDE
Synonyms for IRINOTECAN HYDROCHLORIDE
(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, monohydrochloride
(1,4'-Bipiperidine)-1'-carboxylic acid, 3,4,12,14-tetrahydro-4,11-diethyl-4-hydroxy-3,4-dioxo-1H-pyrano(3',4':6,7)indolizino(1,2-b)quinolin-9-yl ester, monohydrochloride, (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(11),3,5,7,9,15(20)-heptaen-7-yl [1,4'-bipiperidine]-1'-carboxylate hydrochloride
(19S)-10,19-diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.0?,??.0?,?.0??,??]henicosa-1(21),2(11),3,5,7,9,15(20)-heptaen-7-yl 4-(piperidin-1-yl)piperidine-1-carboxylate hydrochloride
(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 4-(piperidin-1-yl)piperidine-1-carboxylate hydrochloride
(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 [1,4'-bipiperidine]-1'-carboxylic acid ester hydrochloride
(4s)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1h-pyrano[3',4':6,7]indolizino[1,2-b]chinolin-9-yl-1,4'-bipiperidin-1'-carboxylathydrochlorid
(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
(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
(S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3 inverted exclamation marka,4 inverted exclamation marka:6,7]indolizino[1,2-b]quinolin-9-yl ester
(S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3 inverted exclamation marka,4 inverted exclamation marka:6,7]indolizino[1,2-b]quinolin-9-yl ester; [1,4 inverted exclamation marka-Bipiperidine]-1 inverted
(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 hydrochloride
[1, 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 (S)-
[1,4 inverted exclamation mark -Bipiperidine]-1 inverted exclamation mark -carboxylic Acid (4S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3 inverted exclamation mark ,4 inverted exclamation mark :6,7]in
[1,4 inverted exclamation marka-Bipiperidine]-1 inverted exclamation marka-carboxylic acid
06X131E4OE
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
100286-90-6
111348-33-5
286I906
7-Ethyl-10-(4-(1-piperidino)-1-piperidino)carbonyloxy camptothecin hydrochloride
AB0013307
AB1004843
AC-28335
AC1L2MZI
AC1Q3ESY
AK163168
AKOS015901921
AN-34403
AS-13304
BC206170
C33H38N4O6.HCl
Campto
Camptosar (TN) (Pharmacia)
Camptothecin 11
Camptothecin 11 hydrochloride
Camptothecin analog
CAS-100286-90-6
CCG-213561
CHEBI:5971
CHEMBL541887
CPT 11
CPT-11
CPT11,
CS-2988
DQ-2805
DSSTox_CID_25953
DSSTox_GSID_45953
DSSTox_RID_81249
DTXSID6045953
EBD19661
FT-0627291
GURKHSYORGJETM-WAQYZQTGSA-N
H851
HMS1922J04
HY-16562A
I0714
Irinotecan (hydrochloride)
Irinotecan Hcl
irinotecan hydrochloride (anhydrous)
Irinotecan hydrochloride [USAN:JAN]
Irinotecan hydrochloride, topoisomerase inhibitor
irinotecan monohydrochloride
KS-00000Y33
LS-44591
MCULE-3850427409
MFCD01862255
MolPort-003-666-755
NCGC00095190-01
NCGC00095190-02
NCGC00178697-04
NE46825
NSC-616348
NSC-759878
NSC616348
NSC759878
Pharmakon1600-01505821
Q-100016
RL00025
SCHEMBL4033
SPECTRUM1505821
ST24047422
ST51054057
TL8000040
Topotecin
Tox21_111479
Tox21_111479_1
U 101440E
U-101440E
UNII-06X131E4OE
Z1550648758

US Patents and Regulatory Information for IRINOTECAN HYDROCHLORIDE

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Fresenius Kabi Oncol IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078188-001 Feb 27, 2008 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hisun Pharm Hangzhou IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090016-001 Jan 28, 2009 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Qilu Pharm Co Ltd IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380-001 May 3, 2016 AP RX No No ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Expired US Patents for IRINOTECAN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for IRINOTECAN HYDROCHLORIDE

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 ➤ Sign Up
9,717,723 Liposomes useful for drug delivery ➤ Sign Up
9,737,528 Liposomes useful for drug delivery to the brain ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Supplementary Protection Certificates for IRINOTECAN HYDROCHLORIDE

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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Accenture
Boehringer Ingelheim
Healthtrust
Harvard Business School
Chinese Patent Office
Deloitte
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.