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Last Updated: October 24, 2021

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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-one patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for eribulin mesylate

International Patents:	81
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
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

Sponsor	Phase
The First Affiliated Hospital with Nanjing Medical University	Phase 2
National Cancer Institute (NCI)	Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2

See all eribulin mesylate clinical trials

Pharmacology for eribulin mesylate

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule 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

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Glossary

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

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

International Patents for eribulin mesylate

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007061874	⤷ Free Forever Trial
Japan	6306235	⤷ Free Forever Trial
Germany	69943296	⤷ Free Forever Trial
Japan	5705814	⤷ Free Forever Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for eribulin mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	C01087960/01	Switzerland	⤷ Free Forever Trial	PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
1087960	SPC/GB11/039	United Kingdom	⤷ Free Forever 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	⤷ Free Forever Trial	PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	2011C/028	Belgium	⤷ Free Forever Trial	PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.