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 is one patent protecting this drug. Additional details are available on the HALAVEN profile page.

The generic ingredient in HALAVEN is eribulin mesylate. Fourteen 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:	1

Pharmacology for NDA: 201532

Physiological Effect	Microtubule 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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/2ML (0.5MG/ML)
Approval Date:	Nov 15, 2010	TE:	AP	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:	RE46965*PED	Patent Expiration:	Jul 8, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 201532

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	6,469,182	⤷ Get Started Free
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	8,097,648	⤷ Get Started Free
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	7,470,720	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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