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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
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Covington
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Cipla
Queensland Health
Dow
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Generated: September 24, 2017

DrugPatentWatch Database Preview

Eisai Inc Company Profile

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What is the competitive landscape for EISAI INC, and what generic alternatives to EISAI INC drugs are available?

EISAI INC has seventeen approved drugs.

There are thirty US patents protecting EISAI INC drugs and there have been two Paragraph IV challenges on EISAI INC drugs in the past three years.

There are four hundred and eighty-five patent family members on EISAI INC drugs in forty-eight countries.

Summary for Applicant: Eisai Inc

Patents:30
Tradenames:13
Ingredients:11
NDAs:17
Drug Master File Entries: (click here to view)1
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
BELVIQ XR
lorcaserin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208524-001Jul 15, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Eisai Inc
BELVIQ
lorcaserin hydrochloride
TABLET;ORAL022529-001Jun 27, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
SOLUTION;ORAL021719-001Oct 18, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Eisai Inc
HALAVEN
eribulin mesylate
SOLUTION;INTRAVENOUS201532-001Nov 15, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Eisai Inc
BELVIQ XR
lorcaserin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208524-001Jul 15, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-002Aug 19, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe
Eisai Inc
BELVIQ
lorcaserin hydrochloride
TABLET;ORAL022529-001Jun 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-004Oct 22, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-005Oct 22, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Eisai Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
Eisai Inc
ARICEPT ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021720-001Oct 18, 2004► Subscribe► Subscribe
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 2002► Subscribe► Subscribe
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 2002► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 1996► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 2010► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 1996► Subscribe► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
Eisai Inc
PANRETIN
alitretinoin
GEL;TOPICAL020886-001Feb 2, 1999► Subscribe► Subscribe
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Paragraph IV activity for EISAI INC drugs

Drugname Dosage Strength Tradename Submissiondate
lorcaserin hydrochloride
Extended-release Tablets20 mg
BELVIQ XR
12/13/2016
perampanel
Tablets2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg
FYCOMPA
10/24/2016
rufinamide
Oral Suspension40 mg/mL
BANZEL
6/16/2014
donepezil hydrochloride
Tablets23 mg
ARICEPT
7/9/2013
rufinamide
Tablets100 mg, 200 mg and 400 mg
BANZEL
11/14/2012
donepezil hydrochloride
Orally Disintegrating Tablets5 mg and 10 mg
ARICEPT ODT
6/30/2010

Premature patent expirations for EISAI INC

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Eisai Inc

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
8,846,9065HT.sub.2C receptor modulators► Subscribe
7,704,993Benzazepine derivatives and methods of prophylaxis or treatment of 5ht2c receptor associated diseases► Subscribe
7,563,8111,2-dihydropyridine compounds, manufacturing method thereof and use thereof► Subscribe
5,968,989 Means for the modulation of processes mediated by retinoid receptors and compounds useful therefor► Subscribe
7,056,954Means for the modulation of processes mediated by retinoid receptors and compounds useful therefor► Subscribe
8,993,7505HT.sub.2C receptor modulators► Subscribe
7,973,160Nitrogen-containing aromatic derivatives► Subscribe
8,404,675Benzazepine derivatives and methods of prophylaxis or treatment of 5HT2C receptor associated diseases► Subscribe
8,304,548Method for producing 1, 2-dihydropyridine-2-one compound► Subscribe
6,992,108Means for the modulation of processes mediated by retinoid receptors and compounds useful therefor► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Eisai Inc Drugs

Country Document Number Estimated Expiration
Hungary0303398► Subscribe
Australia4573999► Subscribe
JapanWO2002032872► Subscribe
Poland396873► Subscribe
Japan2011116780► Subscribe
Slovenia1764361► Subscribe
South Korea20040099426► Subscribe
South Korea100908167► Subscribe
Spain2320973► Subscribe
China1942443► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Eisai Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2011Austria► SubscribePRODUCT NAME: ERIBULIN UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/11/678/001-002 20110317
1087960/01Switzerland► SubscribePRODUCT NAME: ERIBULIN; REGISTRATION NO/DATE: SWISSMEDIC 59489 20110513
/2001Austria► SubscribePRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
2015000083Germany► SubscribePRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528
2015039Lithuania► SubscribePRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
C0070France► SubscribePRODUCT NAME: LENVATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1002 20150601
C0038France► SubscribePRODUCT NAME: ERIBULINE, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER MESYLATE D'ERIBULINE; REGISTRATION NO/DATE: EU/1/11/678/001 20110317
90045-2Sweden► SubscribePRODUCT NAME: PERAMPANEL OCH SALTER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/12/776/001 20120723
858Luxembourg► SubscribePRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
2012 00052Denmark► Subscribe
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Merck
AstraZeneca
Medtronic
Colorcon
Covington
Baxter
Harvard Business School
Fuji
McKinsey

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.

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ISSN: 2162-2639

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