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Last Updated: September 25, 2022

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 Inc and is included in one NDA. There are seventeen patents protecting this drug.

This drug has one hundred and eighteen patent family members in twenty-seven countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Seventeen 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 27th, 2008.

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Summary for ONIVYDE
Drug patent expirations by year for ONIVYDE
Drug Prices for ONIVYDE

See drug prices for ONIVYDE

Recent Clinical Trials for ONIVYDE

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

SponsorPhase
Kaohsiung Medical University Chung-Ho Memorial HospitalPhase 1/Phase 2
Taipei Veterans General Hospital, TaiwanPhase 1/Phase 2
China Medical University HospitalPhase 1/Phase 2

See all ONIVYDE clinical trials

Pharmacology for ONIVYDE

US Patents and Regulatory Information for ONIVYDE

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

Patents protecting ONIVYDE

Stabilizing camptothecin pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liposomes useful for drug delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating pancreatic cancer using combination therapies
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liposomes useful for drug delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liposomes useful for drug delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PANCREATIC CANCER

Liposomes useful for drug delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liposomes useful for drug delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ONIVYDE

FOR USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, FOR THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED FOLLOWING GEMCITABINE-BASED THERAPY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
South Korea 101776808 See Plans and Pricing
South Korea 101462819 See Plans and Pricing
Russian Federation 2011112461 ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ See Plans and Pricing
European Patent Office 3266456 COMBINAISONS CONTENANT DE L'IRINOTÉCAN LIPOSOMAL, DU 5-FU ET DU LEUCOVORIN DESTINÉES AU TRAITEMENT DU CANCER PANCRÉATIQUE (COMBINATIONS OF LIPOSOMAL IRINOTECAN, 5-FU AND LEUCOVORIN FOR THE TREATMENT OF PANCREATIC CANCER) See Plans and Pricing
Norway 20065532 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONIVYDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 17C1027 France See Plans and Pricing PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 CA 2017 00030 Denmark See Plans and Pricing 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
1746976 CR 2017 00030 Denmark See Plans and Pricing PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018
1746976 1790033-3 Sweden See Plans and Pricing PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
1746976 300885 Netherlands See Plans and Pricing PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Medtronic

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