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Last Updated: September 23, 2021

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-one 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.

DrugPatentWatch® 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for HALAVEN
International Patents:81
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 53
Patent Applications: 45
Drug Prices: Drug price information for HALAVEN
What excipients (inactive ingredients) are in HALAVEN?HALAVEN excipients list
DailyMed Link:HALAVEN at DailyMed
Drug patent expirations by year for HALAVEN
Drug Prices for HALAVEN

See drug prices for HALAVEN

DrugPatentWatch® Estimated 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
Paxman Coolers LimitedPhase 2
AZ/DaiichiPhase 2
MedSIRPhase 1/Phase 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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try it Free ⤷  Try it Free
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try it Free ⤷  Try it Free
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for HALAVEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1087960 91854 Luxembourg ⤷  Try it Free 91854, EXPIRES: 20240616
1087960 1190021-4 Sweden ⤷  Try it Free PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG. NO/DATE: EU/1/11/678/001-002 20110317
1087960 11C0038 France ⤷  Try it Free PRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
1087960 C01087960/01 Switzerland ⤷  Try it Free PRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
1087960 2011C/028 Belgium ⤷  Try it Free PRODUCT NAME: ERIBULIN; AUTHORISATION NUMBER AND DATE: EU/1/11/678/001 20110317
1087960 C300493 Netherlands ⤷  Try it Free 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Dow
Express Scripts
Boehringer Ingelheim
Medtronic

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