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Last Updated: September 28, 2021

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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 Inc, Pfizer Inc, 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, Novast Labs, Pliva Lachema, Qilu, Sandoz, Sandoz Inc, Shilpa, Sun Pharma Global, Teva Pharms Usa, Us Antibiotics, West-ward Pharms Int, and Zennova, and is included in twenty-eight NDAs. There are sixteen 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 two patent family members in twenty-five countries.

There are thirty-three drug master file entries for irinotecan hydrochloride. Seventeen suppliers are listed for this compound.

Summary for irinotecan hydrochloride
International Patents:102
US Patents:16
Tradenames:3
Applicants:26
NDAs:28
Drug Master File Entries: 33
Finished Product Suppliers / Packagers: 17
Raw Ingredient (Bulk) Api Vendors: 87
Clinical Trials: 1,340
Patent Applications: 7,290
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

SponsorPhase
Chinese Academy of SciencesPhase 2
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 2
NOXXON Pharma AGPhase 2

See all irinotecan hydrochloride clinical trials

Pharmacology for irinotecan hydrochloride
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
Actavis Totowa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078589-003 Nov 18, 2015 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Emcure Pharms Ltd IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 200771-001 Feb 14, 2012 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Pharms Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090101-003 Feb 27, 2008 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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

Supplementary Protection Certificates for irinotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 1790033-3 Sweden ⤷  Free Forever Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976 300885 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 CA 2017 00030 Denmark ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Merck
Dow
Moodys
McKesson

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