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Last Updated: November 18, 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 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, Neopharma, Pliva Lachema, Qilu Pharm Co Ltd, Sandoz, Sandoz Inc, Shilpa Medicare Ltd, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, 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 seventy-seven patent family members in twenty-four countries.

There are thirty-three drug master file entries for irinotecan hydrochloride. Seventeen suppliers are listed for this compound.

Summary for irinotecan hydrochloride
Recent Clinical Trials for irinotecan hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Wisconsin, MadisonPhase 2
Jean Grem, MDPhase 2
Sorrento Therapeutics, Inc.Phase 2/Phase 3

See all irinotecan hydrochloride clinical trials

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
Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CAMPTOSAR INJECTABLE;INJECTION irinotecan hydrochloride 020571 2004-07-26

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
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Zennova IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090393-003 May 13, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 079068-001 Nov 21, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hospira IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077915-001 Feb 27, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for irinotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 300885 Netherlands   Start Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 2017C/027 Belgium   Start 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 122017000042 Germany   Start 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
1746976 1790033-3 Sweden   Start Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976 CA 2017 00030 Denmark   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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