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Generated: September 25, 2018

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IRINOTECAN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for irinotecan hydrochloride and what is the scope of irinotecan hydrochloride freedom to operate?

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 Oncol, 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, 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.

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

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
Sandoz Inc IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090137-001 Nov 12, 2009 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 079068-002 Nov 21, 2008 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Totowa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078589-001 Feb 27, 2008 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

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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 020571-001 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

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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
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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Fuji
Cipla
Fish and Richardson
Citi
Medtronic
Julphar
Harvard Business School

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