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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 eribulin mesylate patent protection?

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

Eribulin mesylate has forty patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for eribulin mesylate

International Patents:	40
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Clinical Trials:	61
Patent Applications:	7
DailyMed Link:	eribulin mesylate at DailyMed

Pharmacology for eribulin mesylate

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Synonyms for eribulin mesylate

(2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-2-((2S)-3-amino-2-hydroxypropyl)-3-methoxy-26-methyl-20,27-dimethylidenehexacosahydro-11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3

11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3,2-i)furo(2',3':5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5(4H)-one, 2-((2S)-3- amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-,

2-(3-amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)11,15-18,21-24,28-triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3,2-i)furo(2',3'-5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5-(4H)-one methanesu

441045-17-6

AC-27728

AKOS025401973

AKOS030238218

AV9U0660CW

B-1939

C40H59NO11.CH4O3S

CHEBI:70710

CHEMBL1683544

CS-2803

D08914

E 7389

E7389

Eribulin (mesylate)

Eribulin mesilate

Eribulin mesilate (JAN)

Eribulin mesylate (USAN)

Eribulin mesylate [USAN]

Halaven

Halaven (TN)

HY-13442A

NSC-707389

QAMYWGZHLCQOOJ-WRNBYXCMSA-N

UNII-AV9U0660CW

Y1702

Z-3266

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

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Non-Orange Book US Patents for eribulin mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,365,759	Intermediate compounds for preparing macrocylcic analogs
6,653,341	Methods and compositions for use in treating cancer
8,148,554	Methods and compositions for use in treating cancer

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International Patents for eribulin mesylate

Country	Document Number	Estimated Expiration
Canada	2335300
Cyprus	1111516
Hungary	227912
European Patent Office	2272839

Supplementary Protection Certificates for eribulin mesylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4	Finland
/2011	Austria		PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
C026/2011	Ireland		SPC026/2011: 20111128, EXPIRES: 20240615
2011 00022	Denmark