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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
UBS
Cipla
Novartis
Teva
Express Scripts
Merck
Cantor Fitzgerald
Boehringer Ingelheim
Cerilliant

Generated: July 23, 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 eight patents protecting this drug.

This drug has forty-five patent family members in sixteen countries.

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

Summary for Tradename: ONIVYDE

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
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► 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
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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
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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
Mexico2014015391► Subscribe
Russian Federation2011112461► Subscribe
European Patent Office1746976► Subscribe
Israel235937► Subscribe
South Korea20120082039► 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
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:

Healthtrust
Julphar
Fish and Richardson
UBS
Colorcon
Argus Health
Dow
Queensland Health
McKesson
Fuji

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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