ONIVYDE Drug Patent Profile

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 seventeen patents protecting this drug.

This drug has one hundred and twenty-three 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.

Summary for ONIVYDE

International Patents:	123
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	35
Patent Applications:	37
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ONIVYDE
What excipients (inactive ingredients) are in ONIVYDE?	ONIVYDE excipients list
DailyMed Link:	ONIVYDE at DailyMed

See drug prices for ONIVYDE

Recent Clinical Trials for ONIVYDE

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

Sponsor	Phase
National Cheng-Kung University Hospital	Phase 1/Phase 2
Chang Gung Memorial Hospital	Phase 1/Phase 2
National Health Research Institutes, Taiwan	Phase 1/Phase 2

See all ONIVYDE clinical trials

Pharmacology for ONIVYDE

Drug Class	Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ONIVYDE

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ONIVYDE

ONIVYDE is protected by twenty US patents and one FDA Regulatory Exclusivity.

Patents protecting ONIVYDE

FDA Regulatory Exclusivity protecting ONIVYDE

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
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes			Y	Y

International Patents for ONIVYDE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2022203167	Stabilizing camptothecin pharmaceutical compositions
European Patent Office	1746976	LIPOSOMES UTILES POUR L'ADMINISTRATION DE MEDICAMENTS (LIPOSOMES USEFUL FOR DRUG DELIVERY)
Israel	304631	אירינוטקאן סוכרוז אוקטסולפט ליפוזומלי בשילוב עם לאוקובורין ו - 5 -פלואוראורציל לשימוש בטיפול בסרטן הלבלב (Liposomal irinotecan sucrose octasulfate in combination with leucovorin and 5-fluorouracil for use in treating pancreatic cancer)
Israel	258283	ייצוב תכשירי רוקחות של קמפטותצין (Stabilizing camptothecin pharmaceutical compositions)
Taiwan	I359029
Norway	345218
Singapore	10201912568P	STABILIZING CAMPTOTHECIN PHARMACEUTICAL COMPOSITIONS

Supplementary Protection Certificates for ONIVYDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746976	122017000042	Germany		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	LUC00026	Luxembourg		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	300885	Netherlands		PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	132017000076571	Italy		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	17C1027	France		PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976	1790033-3	Sweden		PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976	CA 2017 00030	Denmark		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)...; REG. NO/DATE: EU/1 /16/1130 20161018