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McKinsey
Covington
Express Scripts
QuintilesIMS
Chubb
Julphar
Healthtrust
Mallinckrodt
McKesson

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201532

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NDA 201532 describes HALAVEN, which 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. Additional details are available on the HALAVEN profile page.

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 201532
Tradename:HALAVEN
Applicant:Eisai Inc
Ingredient:eribulin mesylate
Patents:4
Generic Entry Opportunity Date for 201532
Generic Entry Date for 201532*:
Constraining patent/regulatory exclusivity:
Dosage::
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 201532
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 201532
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532 NDA Eisai Inc. 62856-389 N 62856-389-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1MG/2ML (0.5MG/ML)
Approval Date:Nov 15, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2019
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.
Regulatory Exclusivity Expiration:Jan 28, 2023
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLNE-CONTAINING REGIMEN
Patent:➤ Sign UpPatent Expiration:Jul 20, 2023Product Flag?Substance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
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Dow
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