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Last Updated: January 30, 2023

Eribulin mesylate - Generic Drug Details


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What are the generic drug sources for eribulin mesylate and what is the scope of freedom to operate?

Eribulin mesylate is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eribulin mesylate has seventy-eight patent family members in twenty-six countries.

Two suppliers are listed for this compound.

Summary for eribulin mesylate
International Patents:78
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 43
Clinical Trials: 83
Patent Applications: 11
What excipients (inactive ingredients) are in eribulin mesylate?eribulin mesylate excipients list
DailyMed Link:eribulin mesylate at DailyMed
Recent Clinical Trials for eribulin mesylate

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
Australia New Zealand Gynaecological Oncology GroupPhase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all eribulin mesylate clinical trials

Pharmacology for eribulin mesylate
Drug Class Microtubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE
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 eribulin mesylate

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 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
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
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
>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 eribulin mesylate

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 eribulin mesylate

Country Patent Number Title Estimated Expiration
Germany 122011100031 See Plans and Pricing
European Patent Office 3587408 INTERMÉDIAIRES POUR LA PRÉPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B) See Plans and Pricing
Israel 180252 תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b) See Plans and Pricing
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) See Plans and Pricing
European Patent Office 2272839 Intermédiaires pour la préparation d'analogues d'halichondrine (Intermediate compounds for the preparation of halichondrin analogs) See Plans and Pricing
Canada 2755266 METHODES DE PREPARATION D'ANALOGUES MACROCYCLIQUES ET INTERMEDIAIRES POUR CETTE METHODE (METHODS FOR PREPARING MACROCYCLIC ANALOGS AND INTERMEDIATES FOR PREPARING SAME) See Plans and Pricing
Hong Kong 1035534 MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eribulin mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1087960 CA 2011 00022 Denmark See Plans and Pricing
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 C300493 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
1087960 394 Finland See Plans and Pricing
1087960 C01087960/01 Switzerland See Plans and Pricing PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
1087960 SPC026/2011 Ireland See Plans and Pricing SPC026/2011: 20111128, EXPIRES: 20240615
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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