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HALAVEN Drug Profile

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Halaven is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug.

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

The generic ingredient in HALAVEN is eribulin mesylate. One supplier is listed for this compound. Additional details are available on the eribulin mesylate profile page.

Summary for Tradename: HALAVEN

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: HALAVEN

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
HALAVEN
eribulin mesylate
SOLUTION;INTRAVENOUS201532-001Nov 15, 2010RXYes8,097,648► subscribe ► subscribe
Eisai Inc
HALAVEN
eribulin mesylate
SOLUTION;INTRAVENOUS201532-001Nov 15, 2010RXYes► subscribe► subscribe
Eisai Inc
HALAVEN
eribulin mesylate
SOLUTION;INTRAVENOUS201532-001Nov 15, 2010RXYes7,470,720► subscribeY ► subscribe
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Non-Orange Book Patents for Tradename: HALAVEN

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
6,365,759 Intermediate compounds for preparing macrocylcic analogs► subscribe
8,148,554Methods and compositions for use in treating cancer► subscribe
6,653,341 Methods and compositions for use in treating cancer► 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: HALAVEN

Country Document Number Estimated Expiration
Canada2632433► subscribe
Canada2755266► subscribe
European Patent Office2272839► 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: HALAVEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960/01Switzerland► subscribePRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
C0038France► subscribePRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
854Luxembourg► subscribe91854, EXPIRES: 20240616
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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 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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