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IRINOTECAN HYDROCHLORIDE Drug Profile

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Which patents cover Irinotecan Hydrochloride, and what generic alternatives are available?

Irinotecan Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Ingenus Pharms Llc, Intas Pharms Usa, Jiangsu Hengrui Med, Neopharma, Pliva Lachema, Qilu, Sandoz, Sandoz Inc, Shilpa Medicare Ltd, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova. and is included in twenty-five NDAs.

The generic ingredient in IRINOTECAN HYDROCHLORIDE 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.

US ANDA Litigation and Generic Entry Outlook for Irinotecan Hydrochloride

A generic version of IRINOTECAN HYDROCHLORIDE was approved as irinotecan hydrochloride by CIPLA LTD on January 29^th, 2020.

Summary for IRINOTECAN HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	25
Suppliers / Packagers:	15
Bulk Api Vendors:	75
Clinical Trials:	1,220
Patent Applications:	4,372
Formulation / Manufacturing:	see details
DailyMed Link:	IRINOTECAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for IRINOTECAN HYDROCHLORIDE

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

Sponsor	Phase
Yanhong Deng	Phase 3
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all IRINOTECAN HYDROCHLORIDE clinical trials

Pharmacology for IRINOTECAN HYDROCHLORIDE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

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
Sandoz Inc	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	090137-002	Nov 12, 2009		DISCN	No	No
Neopharma	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	078953-002	Apr 15, 2010	AP	RX	No	No
West-ward Pharms Int	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	078753-001	Dec 24, 2008	AP	RX	No	No