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 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.

Two suppliers are listed for this compound.

Summary for eribulin mesylate

International Patents:	78
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	83
Patent Applications:	11
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		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing			Y	See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing			Y	See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	See Plans and Pricing	See Plans and Pricing
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	See Plans and Pricing	See Plans and Pricing
>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
Germany	122011100031		See Plans and Pricing
European Patent Office	3587408	INTERMÉDIAIRES POUR LA PRÉPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B)	See Plans and Pricing
Israel	180252	תרכובות ושיטות להכנת אנלוג של@הליקונדרין@b (Compounds and methods for the preparation of an analog of halichondrin b)	See Plans and Pricing
Japan	2016183171	ハリコンドリンＢ類似体の調製用中間体 (INTERMEDIATES FOR PREPARATION OF HALICHONDRIN B ANALOGS)	See Plans and Pricing
European Patent Office	2272839	Intermédiaires pour la préparation d'analogues d'halichondrine (Intermediate compounds for the preparation of halichondrin analogs)	See Plans and Pricing
Canada	2755266	METHODES DE PREPARATION D'ANALOGUES MACROCYCLIQUES ET INTERMEDIAIRES POUR CETTE METHODE (METHODS FOR PREPARING MACROCYCLIC ANALOGS AND INTERMEDIATES FOR PREPARING SAME)	See Plans and Pricing
Hong Kong	1035534	MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION	See Plans and Pricing
>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	300493	Netherlands	See Plans and Pricing	PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	CA 2011 00022	Denmark	See Plans and Pricing
1087960	C201100037	Spain	See Plans and Pricing	PRODUCT NAME: ERIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/678/001-002; DATE OF AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/678/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110317
1087960	C300493	Netherlands	See Plans and Pricing	PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	394	Finland	See Plans and Pricing
1087960	C01087960/01	Switzerland	See Plans and Pricing	PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
1087960	SPC026/2011	Ireland	See Plans and Pricing	SPC026/2011: 20111128, EXPIRES: 20240615
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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