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Last Updated: April 20, 2024

Irinotecan hydrochloride - Generic Drug Details

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

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

Anatomical Therapeutic Chemical (ATC) Classes for irinotecan hydrochloride

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Cipla Ltd	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	077219-002	Feb 20, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	090101-001	Nov 26, 2008	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Qilu Pharm Hainan	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	203380-003	May 3, 2016	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
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
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ 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
World Intellectual Property Organization (WIPO)	2017066726		⤷ Try a Trial
Brazil	112014031088	métodos para o tratamento de câncer pancreático usando terapias de combinação que compreendem irinotecano lipossomal	⤷ Try a Trial
Netherlands	300885		⤷ Try a Trial
Israel	235937	אירינוטקאן סוכרוז אוקטסולפט ליפוזומלי בשילוב עם לאוקוברין ו- 5- פלואורואורציל לשימוש בטיפול בסרטן הלבלב (Liposomal irinotecan sucrose octasulfate in combination with leucovorin and 5-fluorouracil for use in treating pancreatic cancer)	⤷ Try a Trial
Japan	2015523355	リポソームイリノテカンを含む併用療法を用いた、膵臓癌を治療するための方法	⤷ Try a Trial
Taiwan	I729492		⤷ 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	C01746976/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976	CR 2017 00030	Denmark	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
1746976	300885	Netherlands	⤷ Try a Trial	PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	CA 2017 00030	Denmark	⤷ Try a 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
1746976	SPC/GB17/043	United Kingdom	⤷ Try a Trial	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
1746976	LUC00026	Luxembourg	⤷ Try a 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) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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