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HALAVEN Drug Patent Profile

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When do Halaven patents expire, and when can generic versions of Halaven launch?

Halaven is a drug marketed by Eisai Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-eight patent family members in twenty-six countries.

The generic ingredient in HALAVEN is eribulin mesylate. Six suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Halaven

A generic version of HALAVEN was approved as eribulin mesylate by GLAND PHARMA LTD on April 5^th, 2024.

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Summary for HALAVEN

International Patents:	78
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	63
Patent Applications:	7
Drug Prices:	Drug price information for HALAVEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HALAVEN
What excipients (inactive ingredients) are in HALAVEN?	HALAVEN excipients list
DailyMed Link:	HALAVEN at DailyMed

Drug patent expirations by year for HALAVEN

Recent Clinical Trials for HALAVEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
First Affiliated Hospital, Sun Yat-Sen University	Phase 2
Sun Yat-sen University	Phase 2
Shantou Central Hospital	Phase 2

See all HALAVEN clinical trials

Pharmacology for HALAVEN

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Paragraph IV (Patent) Challenges for HALAVEN

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 HALAVEN

HALAVEN is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting HALAVEN

Macrocyclic analogs and methods of their use and preparation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Intermediates for the preparation of analogs of Halichondrin B
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting HALAVEN

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDIES E7389-G000-223 AND E7389-G000-213, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
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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
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Eisai Inc	HALAVEN	eribulin mesylate	SOLUTION;INTRAVENOUS	201532-001	Nov 15, 2010	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 HALAVEN

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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 HALAVEN

See the table below for patents covering HALAVEN around the world.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	2011010		⤷ Sign Up
Japan	2013056923	INTERMEDIATES FOR PREPARATION OF ANALOGS OF HALICHONDRIN B	⤷ Sign Up
Canada	2335300	ANALOGUES MACROCYCLIQUES, LEURS PROCEDES D'UTILISATION ET DEPREPARATION (MACROCYCLIC ANALOGS AND METHODS OF THEIR USE AND PREPARATION)	⤷ Sign Up
Portugal	1087960		⤷ Sign Up
Norway	2011018		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for HALAVEN

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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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description