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Serving 500+ biopharmaceutical companies globally:

Chubb
Farmers Insurance
Colorcon
Cipla
QuintilesIMS
McKesson
US Department of Justice
Teva
Federal Trade Commission
Deloitte

Generated: September 20, 2017

DrugPatentWatch Database Preview

ONIVYDE Drug Profile

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What is the patent landscape for Onivyde, and what generic Onivyde alternatives are available?

Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has forty-seven patent family members in eighteen countries.

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

Summary for Tradename: ONIVYDE

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list61
Clinical Trials: see list4
Patent Applications: see list3,392
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ONIVYDE at DailyMed

Pharmacology for Tradename: ONIVYDE

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;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Ipsen Inc
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION)207793-001Oct 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Tradename: ONIVYDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,658,203Liposomes useful for drug delivery to the brain► Subscribe
9,737,528Liposomes useful for drug delivery to the brain► Subscribe
9,717,723Liposomes useful for drug delivery► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ONIVYDE

Country Document Number Estimated Expiration
Denmark2861210► Subscribe
European Patent Office3173073► Subscribe
Denmark1746976► Subscribe
China103948545► Subscribe
China104717961► Subscribe
Russian Federation2011112461► Subscribe
Japan2015523355► Subscribe
Taiwan201412345► Subscribe
Mexico2014015391► Subscribe
Australia2013202947► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ONIVYDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885Netherlands► SubscribePRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
C/GB97/010United Kingdom► SubscribePRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Cerilliant
Chubb
Farmers Insurance
Moodys
Covington
Cipla
Chinese Patent Office
Argus Health
McKinsey

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 verifification 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.

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