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Generated: April 19, 2019

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Irinotecan hydrochloride - Generic Drug Details

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What are the generic 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, Emcure Pharms Ltd, Fresenius Kabi Usa, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Ingenus Pharms Llc, Intas Pharms Usa, Jiangsu Hengrui Med, Mustafa Nevzat Ilac, Neopharma, Pliva Lachema, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Shilpa Medicare Ltd, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty-six 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-seven patent family members in twenty-four countries.

There are thirty-three drug master file entries for irinotecan hydrochloride. Sixteen 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-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 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
BCP17234
C33H38N4O6.HCl
Campto
Camptosar
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
MolPort-003-666-755
NCGC00095190-01
NCGC00095190-02
NCGC00178697-04
NE46825
NSC-616348
NSC-759878
NSC616348
NSC759878
Pharmakon1600-01505821
Q-100016
RL00025
SCHEMBL4033
SPECTRUM1505821
SR-01000763864
SR-01000763864-3
ST24047422
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
Hisun Pharm Hangzhou IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090016-001 Jan 28, 2009 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharma Global IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078805-002 Apr 21, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077915-001 Feb 27, 2008 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Intas Pharms Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203054-002 Aug 31, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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

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

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Supplementary Protection Certificates for irinotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0137145 SPC/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
1746976 1790033-3 Sweden ➤ Try a Free Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976 2017C/027 Belgium ➤ Try a Free Trial PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976 300885 Netherlands ➤ Try a Free Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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