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Last Updated: November 6, 2024

onivyde Drug Patent 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 and is included in one NDA. There are nineteen patents protecting this drug.

This drug has one hundred and fifty-one patent family members in twenty-eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Onivyde

A generic version of onivyde was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27^th, 2008.

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Summary for onivyde

International Patents:	151
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	35
Patent Applications:	36
Drug Prices:	Drug price information for onivyde
What excipients (inactive ingredients) are in onivyde?	onivyde excipients list
DailyMed Link:	onivyde at DailyMed

Drug patent expirations by year for onivyde

Drug Prices for onivyde

Recent Clinical Trials for onivyde

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Taipei Veterans General Hospital, Taiwan	Phase 1/Phase 2
China Medical University Hospital	Phase 1/Phase 2
National Cheng-Kung University Hospital	Phase 1/Phase 2

See all onivyde clinical trials

Pharmacology for onivyde

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for onivyde

onivyde is protected by twenty-two US patents and two FDA Regulatory Exclusivities.

Patents protecting onivyde

Stabilizing camptothecin pharmaceutical compositions
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Patent Expiration: ⤷ Sign Up

Liposomes useful for drug delivery
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Patent Expiration: ⤷ Sign Up

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Stabilizing camptothecin pharmaceutical compositions
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Patented Use: TREATMENT OF METASTATIC PANCREATIC ADENOCARCINOMA IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL, AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies
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Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

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Liposomes useful for drug delivery
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Liposomes useful for drug delivery
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Liposomes useful for drug delivery
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Patented Use: TREATMENT OF PANCREATIC CANCER

Liposomes useful for drug delivery
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Patent Expiration: ⤷ Sign Up

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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Patented Use: TREATMENT OF EXOCRINE PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT NOT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE

Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN

Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting onivyde

FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷ Sign Up

IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷ Sign Up

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

International Patents for onivyde

See the table below for patents covering onivyde around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	3006109	LIPOSOMES POUR L'ADMINISTRATION DE DROGUES CONTENANT DES POLYOLS ANIONIQUES OU DES SUCRES ANIONIQUES (DRUG DELIVERY LIPOSOMES CONTAINING ANIONIC POLYOLS OR ANIONIC SUGARS)	⤷ Sign Up
Slovenia	2861210		⤷ Sign Up
South Korea	20120082039	LIPOSOMES USEFUL FOR DRUG DELIVERY	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013188586		⤷ Sign Up
Taiwan	201412345	Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan	⤷ Sign Up
Mexico	2014015391	METODOS PARA TRATAR CANCER PANCREÁTICO MEDIANTE EL USO DE TERAPIAS DE COMBINACION QUE COMPRENDEN IRINOTECANO LIPOSÓMICO. (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for onivyde

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	LUC00026	Luxembourg	⤷ Sign Up	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	CR 2017 00030	Denmark	⤷ Sign Up	PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
1746976	300885	Netherlands	⤷ Sign Up	PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	2017C/027	Belgium	⤷ Sign Up	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	C01746976/01	Switzerland	⤷ Sign Up	PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976	122017000042	Germany	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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