Last Updated: June 11, 2026

IRINOTECAN Drug Patent Profile


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

Irinotecan is a drug marketed by Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pharmobedient, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, and Teva Pharms Usa. and is included in twenty-six NDAs.

The generic ingredient in IRINOTECAN is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Irinotecan

A generic version of IRINOTECAN was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27th, 2008.

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Summary for IRINOTECAN
US Patents:0
Applicants:23
NDAs:26
Drug Prices: Drug price information for IRINOTECAN
DailyMed Link:IRINOTECAN at DailyMed

US Patents and Regulatory Information for IRINOTECAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pliva Lachema IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078122-001 Oct 31, 2008 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077915-001 Feb 27, 2008 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090137-002 Nov 12, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Qilu Pharm Hainan IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380-003 May 3, 2016 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Shilpa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 208718-001 Dec 28, 2018 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.