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Last Updated: April 11, 2021

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ERIBULIN MESYLATE - Generic Drug Details

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What are the generic 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: 29
Clinical Trials: 73
Patent Applications: 7
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
The First Affiliated Hospital with Nanjing Medical UniversityPhase 2
National Cancer Institute (NCI)Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2

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

Supplementary Protection Certificates for ERIBULIN MESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 25/2011 Austria   Start Trial PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960 2011C/028 Belgium   Start Trial PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
1087960 C300493 Netherlands   Start Trial PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960 C01087960/01 Switzerland   Start 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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