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Last Updated: March 29, 2024

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HALAVEN Drug Patent Profile


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Which patents cover Halaven, and what generic alternatives are available?

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. Two suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

DrugPatentWatch® Generic Entry Outlook for Halaven

Halaven was eligible for patent challenges on November 15, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 8, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for HALAVEN
Drug Prices for HALAVEN

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for HALAVEN
Generic Entry Date for HALAVEN*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for HALAVEN

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

SponsorPhase
Australia New Zealand Gynaecological Oncology GroupPhase 2
Merck Sharp & Dohme LLCPhase 2
Criterium, Inc.Phase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HALAVEN is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting HALAVEN

Macrocyclic analogs and methods of their use and preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Intermediates for the preparation of analogs of Halichondrin B
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  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

International Patents for HALAVEN

When does loss-of-exclusivity occur for HALAVEN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05250487
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 67984
Estimated Expiration: ⤷  Try a Trial

Patent: 22994
Estimated Expiration: ⤷  Try a Trial

Patent: 35786
Estimated Expiration: ⤷  Try a Trial

Patent: 28453
Estimated Expiration: ⤷  Try a Trial

China

Patent: 93342
Estimated Expiration: ⤷  Try a Trial

Patent: 1899026
Estimated Expiration: ⤷  Try a Trial

Patent: 4876896
Estimated Expiration: ⤷  Try a Trial

Patent: 8997267
Estimated Expiration: ⤷  Try a Trial

Patent: 9180615
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150543
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 71431
Estimated Expiration: ⤷  Try a Trial

Patent: 22663
Estimated Expiration: ⤷  Try a Trial

Patent: 49652
Estimated Expiration: ⤷  Try a Trial

Patent: 87408
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 46436
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0252
Estimated Expiration: ⤷  Try a Trial

Patent: 7402
Estimated Expiration: ⤷  Try a Trial

Patent: 7474
Estimated Expiration: ⤷  Try a Trial

Patent: 7620
Estimated Expiration: ⤷  Try a Trial

Patent: 7606
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 26304
Estimated Expiration: ⤷  Try a Trial

Patent: 05814
Estimated Expiration: ⤷  Try a Trial

Patent: 64926
Estimated Expiration: ⤷  Try a Trial

Patent: 38316
Estimated Expiration: ⤷  Try a Trial

Patent: 06235
Estimated Expiration: ⤷  Try a Trial

Patent: 08501715
Estimated Expiration: ⤷  Try a Trial

Patent: 13056923
Estimated Expiration: ⤷  Try a Trial

Patent: 15061845
Estimated Expiration: ⤷  Try a Trial

Patent: 16183171
Estimated Expiration: ⤷  Try a Trial

Patent: 17141241
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 22663
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 054
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 22663
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1434673
Estimated Expiration: ⤷  Try a Trial

Patent: 070030260
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 48200
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Hungary 0103357 Halichondrinanalógok és eljárás előállításukra és alkalmazásukra (HALICHONDRIN ANALOGS AND METHODS OF THEIR USE AND PREPARATION) ⤷  Try a Trial
Germany 69943296 ⤷  Try a Trial
Japan 2016183171 ハリコンドリンB類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS) ⤷  Try a Trial
Canada 2935786 INTERMEDIAIRES POUR LA PREPARATION D'ANALOGUES D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF ANALOGS OF HALICHONDRIN B) ⤷  Try a Trial
China 104876896 Intermediates For Preparation Of Analogs Of Halichondrin B ⤷  Try a Trial
China 101899026 Intermediates for the preparation of halichondrin B ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HALAVEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 122011100031 Germany ⤷  Try a Trial PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960 2011C/028 Belgium ⤷  Try a Trial PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
1087960 SPC/GB11/039 United Kingdom ⤷  Try a Trial 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 C300493 Netherlands ⤷  Try a Trial PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960 C201100037 Spain ⤷  Try a Trial PRODUCT NAME: ERIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/678/001-002; DATE OF AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/678/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1087960 C01087960/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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