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Last Updated: March 19, 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
Qilu Pharm Hainan IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380-001 May 3, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 213278-004 Apr 11, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Totowa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078589-003 Nov 18, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hengrui Pharma IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090675-001 Dec 16, 2011 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996 AP RX Yes Yes ⤷  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 ⤷  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
>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 020571-002 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 020571-001 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

Country Patent Number Title Estimated Expiration
Japan 2012092119 LIPOSOME USEFUL FOR DRUG DELIVERY ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005107712 ⤷  Try a Trial
Spain 2632915 ⤷  Try a Trial
Japan 2017149783 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 (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOME IRINOTECAN) ⤷  Try a Trial
China 110051631 使用含脂质体伊立替康的组合疗法治疗胰腺癌的方法 (Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan) ⤷  Try a Trial
Russian Federation 2015155368 ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ ⤷  Try a Trial
Russian Federation 2732567 СТАБИЛИЗИРОВАННЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ КАМПТОТЕЦИНА (STABILIZED PHARMACEUTICAL COMPOSITIONS OF CAMPTOTHECIN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for irinotecan hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 SPC/GB17/043 United Kingdom ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
1746976 17C1027 France ⤷  Try a Trial PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 132017000076571 Italy ⤷  Try a Trial PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018
1746976 C01746976/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976 300885 Netherlands ⤷  Try a Trial PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 CR 2017 00030 Denmark ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
0137145 SPC/GB97/010 United Kingdom ⤷  Try a Trial PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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