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Last Updated: May 20, 2024

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 two branded drugs marketed by Gland Pharma Ltd and Eisai Inc, and is included in two NDAs. 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.

Four suppliers are listed for this compound.

Summary for eribulin mesylate

International Patents:	78
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	84
Patent Applications:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eribulin mesylate
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
Merck Sharp & Dohme LLC	Phase 2
Australia New Zealand Gynaecological Oncology Group	Phase 2
M.D. Anderson Cancer Center	Phase 1/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	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

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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	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gland Pharma Ltd	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218047-001	Apr 5, 2024	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	⤷ Try a Trial	⤷ Try a 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	Title	Estimated Expiration
Spain	2748200		⤷ Try a Trial
European Patent Office	2277873	Intermédiaire pour la préparation d'analogues d'halichondrine (Intermediate compound for the preparation of halichondrin analogs)	⤷ Try a Trial
China	104876896	Intermediates For Preparation Of Analogs Of Halichondrin B	⤷ Try a Trial
Japan	2008501715		⤷ Try a Trial
Norway	20006316		⤷ Try a Trial
Denmark	1087960		⤷ Try a Trial
Israel	139960		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for eribulin mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1087960	CA 2011 00022	Denmark	⤷ Try a Trial
1087960	122011100031	Germany	⤷ Try a Trial	PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON, INSBESONDERE ERIBULINMESYLAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	C300493	Netherlands	⤷ Try a Trial	PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	SPC026/2011	Ireland	⤷ Try a Trial	SPC026/2011: 20111128, EXPIRES: 20240615
1087960	132011901976051	Italy	⤷ Try a Trial	PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
1087960	394	Finland	⤷ Try a Trial
1087960	11C0038	France	⤷ Try a Trial	PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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