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Last Updated: December 11, 2024

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HALAVEN Drug Patent Profile


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When do Halaven patents expire, and when can generic versions of Halaven launch?

Halaven is a drug marketed by Eisai Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-six countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Halaven

A generic version of HALAVEN was approved as eribulin mesylate by GLAND PHARMA LTD on April 5th, 2024.

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Drug patent expirations by year for HALAVEN
Drug Prices for HALAVEN

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Recent Clinical Trials for HALAVEN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Guangdong Provincial People's HospitalPhase 2
First Affiliated Hospital, Sun Yat-Sen UniversityPhase 2
Sun Yat-sen UniversityPhase 2

See all HALAVEN clinical trials

Pharmacology for HALAVEN
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for HALAVEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HALAVEN Injection eribulin mesylate 1 mg/2 mL 201532 1 2019-12-20

US Patents and Regulatory Information for HALAVEN

HALAVEN is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting HALAVEN

Macrocyclic analogs and methods of their use and preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Intermediates for the preparation of analogs of Halichondrin B
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting HALAVEN

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
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for HALAVEN

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

International Patents for HALAVEN

See the table below for patents covering HALAVEN around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2245335 МАКРОЦИКЛИЧЕСКОЕ СОЕДИНЕНИЕ И СПОСОБ ИДЕНТИФИКАЦИИ АГЕНТА НА ЕГО ОСНОВЕ (MACROCYCLIC COMPOUND AND METHOD FOR IDENTIFYING AGENT BASED ON THEREOF) ⤷  Sign Up
Japan 6306235 ⤷  Sign Up
Israel 180252 תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b) ⤷  Sign Up
Japan 5964926 ⤷  Sign Up
France 11C0038 ⤷  Sign Up
China 108997267 用于制备软海绵素B的类似物的中间体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HALAVEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 11C0038 France ⤷  Sign Up PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
1087960 91854 Luxembourg ⤷  Sign Up PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011
1087960 SPC/GB11/039 United Kingdom ⤷  Sign Up PRODUCT NAME: ERIBULIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/11/678/001 20110317; UK EU/1/11/678/002 20110317
1087960 CA 2011 00022 Denmark ⤷  Sign Up
1087960 300493 Netherlands ⤷  Sign Up PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960 132011901976051 Italy ⤷  Sign Up PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.