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Last Updated: March 28, 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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 3
Mirati TherapeuticsPhase 1
MEI Pharma, Inc.Phase 1

See all irinotecan hydrochloride clinical trials

Pharmacology for irinotecan hydrochloride
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078953-002 Apr 15, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Totowa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078589-001 Feb 27, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
West-ward Pharms Int IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078753-002 Dec 24, 2008 AP RX 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

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 020571-001 Jun 14, 1996 ⤷  Try a Trial ⤷  Try a 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 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 122017000042 Germany ⤷  Try a Trial PRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976 300885 Netherlands ⤷  Try a Trial PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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