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Last Updated: September 27, 2022

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. 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 January 8, 2027. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for HALAVEN
International Patents:78
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 61
Patent Applications: 51
Drug Prices: Drug price information for HALAVEN
What excipients (inactive ingredients) are in HALAVEN?HALAVEN excipients list
DailyMed Link:HALAVEN at DailyMed
Drug patent expirations by year for HALAVEN
Drug Prices for HALAVEN

See drug prices for HALAVEN

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Criterium, Inc.Phase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2
Beijing 302 HospitalPhase 2

See all HALAVEN clinical trials

Pharmacology for HALAVEN
Drug Class Microtubule 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 one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HALAVEN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Intermediates for the preparation of analogs of Halichondrin B
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting HALAVEN

TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLNE-CONTAINING REGIMEN
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 See Plans and Pricing See Plans and Pricing
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Canada

Patent: 67984
Estimated Expiration: See Plans and Pricing

Patent: 22994
Estimated Expiration: See Plans and Pricing

Patent: 35786
Estimated Expiration: See Plans and Pricing

Patent: 28453
Estimated Expiration: See Plans and Pricing

China

Patent: 93342
Estimated Expiration: See Plans and Pricing

Patent: 1899026
Estimated Expiration: See Plans and Pricing

Patent: 4876896
Estimated Expiration: See Plans and Pricing

Patent: 8997267
Estimated Expiration: See Plans and Pricing

Patent: 9180615
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150543
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 71431
Estimated Expiration: See Plans and Pricing

Patent: 22663
Estimated Expiration: See Plans and Pricing

Patent: 49652
Estimated Expiration: See Plans and Pricing

Patent: 87408
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 46436
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0252
Estimated Expiration: See Plans and Pricing

Patent: 7402
Estimated Expiration: See Plans and Pricing

Patent: 7474
Estimated Expiration: See Plans and Pricing

Patent: 7620
Estimated Expiration: See Plans and Pricing

Patent: 7606
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26304
Estimated Expiration: See Plans and Pricing

Patent: 05814
Estimated Expiration: See Plans and Pricing

Patent: 64926
Estimated Expiration: See Plans and Pricing

Patent: 38316
Estimated Expiration: See Plans and Pricing

Patent: 06235
Estimated Expiration: See Plans and Pricing

Patent: 08501715
Estimated Expiration: See Plans and Pricing

Patent: 13056923
Estimated Expiration: See Plans and Pricing

Patent: 15061845
Estimated Expiration: See Plans and Pricing

Patent: 16183171
Estimated Expiration: See Plans and Pricing

Patent: 17141241
Estimated Expiration: See Plans and Pricing

Poland

Patent: 22663
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 054
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 22663
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1434673
Estimated Expiration: See Plans and Pricing

Patent: 070030260
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48200
Estimated Expiration: See Plans and Pricing

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
Spain 2748200 See Plans and Pricing
Australia 2005250487 See Plans and Pricing
Japan 2015061845 ハリコンドリンB類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF ANALOGS OF HALICHONDRIN B) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HALAVEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 91854 Luxembourg See Plans and Pricing PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011
1087960 C201100037 Spain See Plans and Pricing 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 300493 Netherlands See Plans and Pricing PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Dow
Express Scripts
Boehringer Ingelheim
Medtronic

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.