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Last Updated: October 25, 2020

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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eribulin mesylate has eighty patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for eribulin mesylate
International Patents:80
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 26
Clinical Trials: 71
Patent Applications: 7
DailyMed Link:eribulin mesylate at DailyMed
Recent Clinical Trials for eribulin mesylate

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

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityPhase 2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2
Immunomedics, Inc.Phase 3

See all eribulin mesylate clinical trials

Pharmacology for eribulin mesylate
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
HALAVEN SOLUTION;INTRAVENOUS eribulin mesylate 201532 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   Start Trial   Start Trial Y   Start Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for eribulin mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 132011901976051 Italy   Start Trial PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
1087960 91854 Luxembourg   Start Trial 91854, EXPIRES: 20240616
1087960 1190021-4 Sweden   Start Trial PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG. NO/DATE: EU/1/11/678/001-002 20110317
1087960 25/2011 Austria   Start Trial PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; 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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