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Last Updated: March 2, 2021

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When do Irinotecan Hydrochloride patents expire, and what generic alternatives are available?

Irinotecan Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Totowa, Akorn, Cipla Ltd, Emcure Pharms Ltd, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Jiangsu Hengrui Med, Neopharma, Novast Labs, 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-six 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 ACTAVIS TOTOWA on February 27th, 2008.

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Drug patent expirations by year for IRINOTECAN HYDROCHLORIDE

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

Institut du Cancer de Montpellier - Val d'AurellePhase 2/Phase 3
Pediatric Brain Tumor ConsortiumPhase 2
Y-mAbs Therapeutics, IncPhase 2

See all IRINOTECAN HYDROCHLORIDE clinical trials

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 IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077994-001 Feb 27, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Neopharma IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078953-001 Apr 15, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharma Global IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078805-002 Apr 21, 2008 DISCN 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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