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Last Updated: November 22, 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 27th, 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

See drug prices for ONIVYDE

Recent Clinical Trials for ONIVYDE

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

SponsorPhase
National Cheng-Kung University HospitalPhase 1/Phase 2
Chang Gung Memorial HospitalPhase 1/Phase 2
National Health Research Institutes, TaiwanPhase 1/Phase 2

See all ONIVYDE clinical trials

Pharmacology for ONIVYDE
Drug ClassTopoisomerase Inhibitor
Mechanism of ActionTopoisomerase 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
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

Stabilizing camptothecin pharmaceutical compositions
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Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
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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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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


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Liposomes useful for drug delivery
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Patent Expiration: ⤷  Sign Up

Liposomes useful for drug delivery
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Patent Expiration: ⤷  Sign Up

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

Liposomes useful for drug delivery
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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
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 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
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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

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
>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
Poland 1746976 ⤷  Sign Up
Russian Federation 2015155368 ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ ⤷  Sign Up
Luxembourg C00026 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONIVYDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 C01746976/01 Switzerland ⤷  Sign Up PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017
1746976 CA 2017 00030 Denmark ⤷  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)...; REG. NO/DATE: EU/1 /16/1130 20161018
1746976 2017/029 Ireland ⤷  Sign Up PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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