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Last Updated: April 16, 2024

onivyde Drug Patent Profile


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Which patents cover Onivyde, 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 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
Taipei Veterans General Hospital, TaiwanPhase 1/Phase 2
China Medical University HospitalPhase 1/Phase 2
National Cheng-Kung University HospitalPhase 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 US patents and one FDA Regulatory Exclusivity.

Patents protecting onivyde

Stabilizing camptothecin pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liposomes useful for drug delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liposomes useful for drug delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liposomes useful for drug delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PANCREATIC CANCER

Liposomes useful for drug delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liposomes useful for drug delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting onivyde

FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Hong Kong 1252167 用於藥物輸送的脂質體 (LIPOSOMES USEFUL FOR DRUG DELIVERY) ⤷  Try a Trial
Japan 2014055172 LIPOSOMES USEFUL FOR DRUG DELIVERY ⤷  Try a Trial
South Korea 101776808 ⤷  Try a Trial
China 107811971 用于药物输送的脂质体 (Liposomes useful for drug delivery) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for onivyde

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 2017/029 Ireland ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014
1746976 300885 Netherlands ⤷  Try a Trial PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018
1746976 CA 2017 00030 Denmark ⤷  Try a Trial 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 SPC/GB17/043 United Kingdom ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.