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Serving leading biopharmaceutical companies globally:

Novartis
Healthtrust
Argus Health
Cipla
Deloitte
Cerilliant
AstraZeneca
McKesson
Cantor Fitzgerald
Queensland Health

Generated: January 22, 2018

DrugPatentWatch Database Preview

ONIVYDE Drug Profile

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When do Onivyde patents expire, and what generic alternatives are available?

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

This drug has fifty-eight patent family members in twenty-one countries.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for ONIVYDE
Drug patent expirations by year for ONIVYDE
Pharmacology for ONIVYDE

US Patents and Regulatory Information for 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) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Ipsen Inc ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793-001 Oct 22, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,658,203 Liposomes useful for drug delivery to the brain ➤ Subscribe
9,717,723 Liposomes useful for drug delivery ➤ Subscribe
9,737,528 Liposomes useful for drug delivery to the brain ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ONIVYDE

Supplementary Protection Certificates for ONIVYDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017000042 Germany ➤ Subscribe PRODUCT 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 00030 Denmark ➤ Subscribe 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
C/GB97/010 United Kingdom ➤ Subscribe PRODUCT 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
0885 Netherlands ➤ Subscribe PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Novartis
Queensland Health
Teva
Mallinckrodt
Covington
Dow
US Department of Justice
US Army
Accenture

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