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Last Updated: March 29, 2024

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 two suppliers. There are two patents protecting this drug. Additional details are available on the HALAVEN profile page.

The generic ingredient in HALAVEN is eribulin mesylate. Two suppliers are 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:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 BSP Pharmaceuticals SpA 43624-002 43624-002-01 100 TRAY in 1 BOX, UNIT-DOSE (43624-002-01) / 3 mL in 1 TRAY
HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532 NDA Eisai Inc. 62856-389 62856-389-01 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) / 2 mL in 1 VIAL, SINGLE-DOSE

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:Mar 13, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 13, 2025
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDIES E7389-G000-223 AND E7389-G000-213, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Patent:⤷  Try a TrialPatent Expiration:Jan 20, 2024Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 201532

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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