➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Mallinckrodt
Express Scripts
Boehringer Ingelheim
McKesson

Last Updated: October 26, 2021

DrugPatentWatch Database Preview

IRINOTECAN HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic drug 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 four patent family members in twenty-six 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:104
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: 1,358
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
Foundation MedicinePhase 2
Chinese Academy of SciencesPhase 2
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 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
Cipla Ltd IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 077219-001 Feb 20, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Us Antibiotics IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 078953-001 Apr 15, 2010 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Eugia Pharma IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 213278-003 Nov 2, 2020 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Pharms Usa IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 090101-002 Feb 27, 2008 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Qilu IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride INJECTABLE;INJECTION 203380-002 May 3, 2016 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
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
>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

International Patents for IRINOTECAN HYDROCHLORIDE

Country Patent Number Estimated Expiration
China 103948545 ⤷  Free Forever Trial
Canada 2875824 ⤷  Free Forever Trial
Taiwan I630924 ⤷  Free Forever Trial
European Patent Office 2861210 ⤷  Free Forever Trial
Taiwan I724041 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2005107712 ⤷  Free Forever Trial
Taiwan 201831168 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for IRINOTECAN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 300885 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 LUC00026 Luxembourg ⤷  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) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976 2017C/027 Belgium ⤷  Free Forever 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 17C1027 France ⤷  Free Forever Trial PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 122017000042 Germany ⤷  Free Forever 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 132017000076571 Italy ⤷  Free Forever 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
0137145 SPC/GB97/010 United Kingdom ⤷  Free Forever 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Mallinckrodt
Express Scripts
Boehringer Ingelheim
McKesson

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. 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.