Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Express Scripts
Fish and Richardson
Accenture
QuintilesIMS
US Department of Justice
Merck
Deloitte

Generated: July 23, 2018

DrugPatentWatch Database Preview

HALAVEN Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

Which patents cover Halaven, and when can generic versions of Halaven launch?

Halaven is a drug marketed by Eisai Inc and is included in one NDA. There are four patents protecting this drug.

This drug has forty patent family members in twenty-one countries.

The generic ingredient in HALAVEN is eribulin mesylate. One supplier is listed for this compound. Additional details are available on the eribulin mesylate profile page.
Summary for HALAVEN
International Patents:40
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 15
Clinical Trials: 38
Patent Applications: 7
DailyMed Link:HALAVEN at DailyMed
Drug patent expirations by year 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.

Pharmacology for HALAVEN
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Synonyms for HALAVEN
(2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-2-((2S)-3-amino-2-hydroxypropyl)-3-methoxy-26-methyl-20,27-dimethylidenehexacosahydro-11,15:18,21:24,28-triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3
11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3,2-i)furo(2',3':5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5(4H)-one, 2-((2S)-3- amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-,
2-(3-amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)11,15-18,21-24,28-triepoxy-7,9-ethano-12,15-methano-9H,15H-furo(3,2-i)furo(2',3'-5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5-(4H)-one methanesu
441045-17-6
AC-27728
AKOS025401973
AKOS030238218
AV9U0660CW
B-1939
C40H59NO11.CH4O3S
CHEBI:70710
CHEMBL1683544
CS-2803
D08914
E 7389
E7389
Eribulin (mesylate)
Eribulin mesilate
Eribulin mesilate (JAN)
Eribulin mesylate
Eribulin mesylate (USAN)
Eribulin mesylate [USAN]
Halaven (TN)
HY-13442A
NSC-707389
QAMYWGZHLCQOOJ-WRNBYXCMSA-N
UNII-AV9U0660CW
Y1702
Z-3266

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Non-Orange Book US Patents for HALAVEN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,365,759 Intermediate compounds for preparing macrocylcic analogs ➤ Sign Up
8,148,554 Methods and compositions for use in treating cancer ➤ Sign Up
6,653,341 Methods and compositions for use in treating cancer ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for HALAVEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 Finland ➤ Sign Up
90021-4 Sweden ➤ Sign Up PRODUCT NAME: ERIBULIN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV, I SYNNERHET ERIBULINMESYLAT; REG. NO/DATE: EU/1/11/678/001-002 20110317
C026/2011 Ireland ➤ Sign Up SPC026/2011: 20111128, EXPIRES: 20240615
854 Luxembourg ➤ Sign Up 91854, EXPIRES: 20240616
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Fuji
Colorcon
Cantor Fitzgerald
QuintilesIMS
Julphar
Teva
Merck
McKesson

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 verifification 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.