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 Baxter Hlthcare Corp, Gland Pharma Ltd, Jiangxi Qingfeng, Long Grove Pharms, and Eisai Inc, and is included in five 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.

Six suppliers are listed for this compound.

Summary for ERIBULIN MESYLATE

International Patents:	78
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
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
Baxter Hlthcare Corp	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	217250-001	Oct 1, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Long Grove Pharms	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	214850-001	Jul 18, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jiangxi Qingfeng	ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	218281-001	Jun 28, 2024	AP	RX	No	No	⤷ 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			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
Canada	2335300	ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DEPREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION)	⤷ Sign Up
Japan	5226304		⤷ Sign Up
Portugal	1087960		⤷ Sign Up
Norway	2011018		⤷ Sign Up
China	101899026	Intermediates for the preparation of halichondrin B	⤷ Sign Up
Spain	2748200		⤷ 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	SPC/GB11/039	United Kingdom	⤷ Sign Up	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	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	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
1087960	25/2011	Austria	⤷ Sign Up	PRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960	1191021-3	Sweden	⤷ Sign Up	PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT EU/1/11/678/001-002, 2011-03-17 EG
1087960	132011901976051	Italy	⤷ Sign Up	PRODUCT NAME: ERIBULINA(HALAVEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/678/001-002, 20110317
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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