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 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
Australia New Zealand Gynaecological Oncology Group	Phase 2
Merck Sharp & Dohme LLC	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

Anatomical Therapeutic Chemical (ATC) Classes for ERIBULIN MESYLATE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218047-001	Apr 5, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	⤷ Sign Up	⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	⤷ Sign Up	⤷ Sign Up
>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
World Intellectual Property Organization (WIPO)	2004034990		⤷ Sign Up
Australia	2003284242	METHODS AND COMPOSITIONS FOR USE IN TREATING CANCER	⤷ Sign Up
Hungary	0103357	Halichondrinanalógok és eljárás előállításukra és alkalmazásukra (HALICHONDRIN ANALOGS AND METHODS OF THEIR USE AND PREPARATION)	⤷ Sign Up
European Patent Office	2522663	Intermédiaires pour la préparation d'halichondrine b (Intermediates for the preparation of halichondrin B)	⤷ Sign Up
Hong Kong	1035534	MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION	⤷ Sign Up
Canada	2567984	INTERMEDIAIRES POUR LA PREPARATION D'HALICHONDRINE B (INTERMEDIATES FOR THE PREPARATION OF HALICHONDRIN B)	⤷ Sign Up
>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	91854	Luxembourg	⤷ Sign Up	PRODUCT NAME: ERIBULIN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (HALAVEN ); AUTHORISATION NUMBER AND DATE: EU/1/11/678/001-002, 17.03.2011
1087960	2011C/028	Belgium	⤷ Sign Up	PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
1087960	394	Finland	⤷ Sign Up
1087960	1190021-4	Sweden	⤷ Sign Up	PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG:NO:/DATE: EG EU/1/11/678/001-002, 2011-03-17
1087960	11C0038	France	⤷ Sign Up	PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
1087960	C300493	Netherlands	⤷ Sign Up	PRODUCT NAME: ERIBULIN, ALSMEDE FARMACEUTISCHE ZOUTEN ERVAN, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/11/678/001-002 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.