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Last Updated: August 6, 2020

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ONIVYDE Drug Profile

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When do Onivyde patents expire, and when can generic versions of Onivyde launch?

Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has ninety-one patent family members in twenty-five countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Drug patent expirations by year for ONIVYDE
Drug Prices for ONIVYDE

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Recent Clinical Trials for ONIVYDE

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SponsorPhase
National Cancer Institute (NCI)Phase 3
ECOG-ACRIN Cancer Research GroupPhase 3
Samsung Medical CenterPhase 1

See all ONIVYDE clinical trials

Pharmacology for ONIVYDE

US Patents and Regulatory Information for ONIVYDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ONIVYDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 300885 Netherlands   Start Trial PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 132017000076571 Italy   Start 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 122017000042 Germany   Start 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 2017C/027 Belgium   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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