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Serving leading biopharmaceutical companies globally:

Chubb
McKesson
Moodys
Cantor Fitzgerald
AstraZeneca
Daiichi Sankyo
Boehringer Ingelheim
Teva
Cerilliant
Fuji

Generated: October 19, 2017

DrugPatentWatch Database Preview

FYCOMPA Drug Profile

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What is the patent landscape for Fycompa, and when can generic versions of Fycompa launch?

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

This drug has ninety-nine patent family members in thirty-two countries and sixteen supplementary protection certificates in twelve countries.

The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the perampanel profile page.

Summary for Tradename: FYCOMPA

US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list36
Clinical Trials: see list7
Patent Applications: see list55
Drug Prices:see details
DailyMed Link:FYCOMPA at DailyMed

Pharmacology for Tradename: FYCOMPA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
FYCOMPA
perampanel
SUSPENSION;ORAL208277-001Apr 29, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-005Oct 22, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-005Oct 22, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-001Oct 22, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-003Oct 22, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-004Oct 22, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-002Oct 22, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-006Oct 22, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-001Oct 22, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-002Oct 22, 2012RXYesNo► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for FYCOMPA

Drugname Dosage Strength RLD Submissiondate
perampanelTablets2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mgFycompa10/24/2016

Non-Orange Book Patents for Tradename: FYCOMPA

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
7,563,8111,2-dihydropyridine compounds, manufacturing method thereof and use thereof► Subscribe
8,304,548Method for producing 1, 2-dihydropyridine-2-one compound► Subscribe
9,045,426Method for producing 1,2-dihydropyridine-2-one compound► Subscribe
7,939,5491,2-dihydropyridine compounds, manufacturing method thereof and use thereof► 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.

Export unavailable in trial.
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International Patent Family for Tradename: FYCOMPA

Country Document Number Estimated Expiration
United Kingdom0022483► Subscribe
European Patent Office2177520► Subscribe
Israel152848► Subscribe
Hong Kong1102127► Subscribe
China1436172► Subscribe
South Korea100850728► Subscribe
JapanWO2006004100► Subscribe
China101544599► Subscribe
Taiwan200815402► Subscribe
Canada2561829► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: FYCOMPA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00052Denmark► Subscribe
1300396/01Switzerland► SubscribePRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
12/049Ireland► SubscribePRODUCT NAME: PERAMPANEL, OPTIONALLY A SALT OR HYDRATE THEREOF.; REGISTRATION NO/DATE: EU/1/12/776/001-EU/1/12/776/016 20120723
2013017,C1764361Lithuania► SubscribePRODUCT NAME: PERAMPANELUM; REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016, 2012 07 23 EU/1/12/776/017 - EU1/12/776/023 20121029
C/GB12/057United Kingdom► SubscribePRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
113Luxembourg► SubscribePRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
00566Netherlands► SubscribePRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
2013017Lithuania► SubscribePRODUCT NAME: PERAMPANELUM; REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016, 2012 07 23 EU/1/12/776/017 - EU1/12/776/023 20121029
0565Netherlands► SubscribePRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
C0074France► SubscribePRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
This preview shows a limited data set
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Mallinckrodt
Johnson and Johnson
Novartis
Boehringer Ingelheim
Colorcon
Queensland Health
AstraZeneca
McKinsey
Cerilliant

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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