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Last Updated: April 18, 2024

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, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, and is included in twenty-eight NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Irinotecan hydrochloride has one hundred and twenty-three patent family members in twenty-eight countries.

There are thirty drug master file entries for irinotecan hydrochloride. Sixteen suppliers are listed for this compound.

Summary for irinotecan hydrochloride

International Patents:	123
US Patents:	17
Tradenames:	3
Applicants:	25
NDAs:	28
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1,505
Patent Applications:	6,975
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in irinotecan hydrochloride?	irinotecan hydrochloride excipients list
DailyMed Link:	irinotecan hydrochloride at DailyMed

Recent Clinical Trials for irinotecan hydrochloride

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

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 3
Mirati Therapeutics	Phase 1
MEI Pharma, Inc.	Phase 1

See all irinotecan hydrochloride clinical trials

Pharmacology for irinotecan hydrochloride

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAMPTOSAR	Injection	irinotecan hydrochloride	20 mg/mL, 2 mL and 5 mL vials	020571	1	2004-07-26

US Patents and Regulatory Information for irinotecan hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	213278-002	Nov 2, 2020	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	077994-001	Feb 27, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	213278-004	Apr 11, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gland Pharma Ltd	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	212993-002	Nov 18, 2019	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Accord Hlthcare	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	079068-001	Nov 21, 2008	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Intas Pharms Usa	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	203054-001	Aug 31, 2017	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Emcure Pharms Ltd	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	200771-001	Feb 14, 2012		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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

International Patents for irinotecan hydrochloride

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Country	Patent Number	Title	Estimated Expiration
China	108366965	稳定喜树碱药物组合物 (Stabilizing camptothecin pharmaceutical compositions)	⤷ Try a Trial
Canada	2821167	LIPOSOMES POUR L'ADMINISTRATION DE DROGUES CONTENANT DES POLYOLS ANIONIQUES OU DES SUCRES ANIONIQUES (DRUG DELIVERY LIPOSOMES CONTAINING ANIONIC POLYOLS OR ANIONIC SUGARS)	⤷ Try a Trial
Russian Federation	2663450	СПОСОБЫ ЛЕЧЕНИЯ РАКА ПОДЖЕЛУДОЧНОЙ ЖЕЛЕЗЫ С ПРИМЕНЕНИЕМ КОМБИНИРОВАННОЙ ТЕРАПИИ, ВКЛЮЧАЮЩЕЙ ЛИПОСОМНЫЙ ИРИНОТЕКАН (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPY COMPRISING LIPOSOMAL IRINOTECAN)	⤷ Try a Trial
South Korea	101997206		⤷ Try a Trial
Japan	5665950		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2013188586		⤷ Try a Trial
Canada	2928387	LIPOSOMES POUR L'ADMINISTRATION DE DROGUES CONTENANT DES POLYOLS ANIONIQUES OU DES SUCRES ANIONIQUES (DRUG DELIVERY LIPOSOMES CONTAINING ANIONIC POLYOLS OR ANIONIC SUGARS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for irinotecan hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	132017000076571	Italy	⤷ Try a Trial	PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018
0137145	SPC/GB97/010	United Kingdom	⤷ Try a 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 Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976	17C1027	France	⤷ Try a Trial	PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	SPC/GB17/043	United Kingdom	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
1746976	2017C/027	Belgium	⤷ Try a 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	CR 2017 00030	Denmark	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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