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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Cantor Fitzgerald
McKinsey
Express Scripts
McKesson
Cipla
Deloitte
Daiichi Sankyo
Julphar

Generated: November 18, 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 fifty-six patent family members in nineteen countries and four supplementary protection certificates in four 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.
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► 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► 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► 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► 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
Hong Kong1200694► Subscribe
Japan4971142► Subscribe
Spain2616047► Subscribe
World Intellectual Property Organization (WIPO)2013188586► Subscribe
Ukraine86063► Subscribe
South Korea101223366► Subscribe
Portugal2861210► Subscribe
South Korea101462819► Subscribe
Canada2821167► Subscribe
Taiwan200605908► 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
2017000042Germany► SubscribePRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014
2017 00030Denmark► SubscribePRODUCT 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
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 leading biopharmaceutical companies globally:

Baxter
Deloitte
Moodys
UBS
Cantor Fitzgerald
Johnson and Johnson
Cerilliant
Boehringer Ingelheim
AstraZeneca
Teva

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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