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Last Updated: November 29, 2020

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HALAVEN Drug 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 three patents protecting this drug.

This drug has eighty patent family members in twenty-seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Halaven

Halaven was eligible for patent challenges on November 15, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 8, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for HALAVEN
Drug patent expirations by year for HALAVEN
Drug Prices for HALAVEN

See drug prices for HALAVEN

Generic Entry Opportunity Date for HALAVEN
Generic Entry Date for HALAVEN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for HALAVEN

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

SponsorPhase
The First Affiliated Hospital with Nanjing Medical UniversityPhase 2
National Cancer Institute (NCI)Phase 3
Hoffmann-La RochePhase 2

See all HALAVEN clinical trials

Pharmacology for HALAVEN
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for HALAVEN
Tradename Dosage Ingredient NDA Submissiondate
HALAVEN SOLUTION;INTRAVENOUS eribulin mesylate 201532 2019-12-20

US Patents and Regulatory Information for HALAVEN

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   Start Trial   Start Trial   Start Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for HALAVEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 11C0038 France   Start Trial PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
1087960 91854 Luxembourg   Start Trial 91854, EXPIRES: 20240616
1087960 1190021-4 Sweden   Start Trial PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG. NO/DATE: EU/1/11/678/001-002 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Dow
Express Scripts
Boehringer Ingelheim
Medtronic

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