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Perampanel - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for perampanel?

Perampanel is the generic ingredient in one branded drug marketed by Eisai Inc and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Perampanel has eighty-seven patent family members in thirty-two countries.

There are four drug master file entries for perampanel. One supplier is listed for this compound.

Summary for Generic Name: perampanel

Tradenames:1
Patents:3
Applicants:1
NDAs:2
Drug Master File Entries: see list4
Suppliers / Packagers: see list1
Bulk Api Vendors: see list37
Clinical Trials: see list14
Patent Applications: see list85
Drug Prices:see low prices
DailyMed Link:perampanel at DailyMed

Pharmacology for Ingredient: perampanel

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-006Oct 22, 2012RXYesYes► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-004Oct 22, 2012RXYesNo6,949,571► SubscribeYY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-003Oct 22, 2012RXYesNo► Subscribe► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-001Oct 22, 2012RXYesNo8,772,497► SubscribeY ► Subscribe
Eisai Inc
FYCOMPA
perampanel
TABLET;ORAL202834-002Oct 22, 2012RXYesNo6,949,571► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: perampanel

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

Country Document Number Estimated Expiration
Portugal1764361► Subscribe
China104402808► Subscribe
South Korea101187218► Subscribe
Hungary229553► Subscribe
European Patent Office1300396► 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 Tradename: PERAMPANEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3 5-2013Slovakia► SubscribePRODUCT NAME: PERAMPANEL; NAT. REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016 20120723; FIRST REGISTRATION: EU 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
00566Netherlands► SubscribePRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
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
90045-2Sweden► SubscribePRODUCT NAME: PERAMPANEL OCH SALTER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/12/776/001 20120723
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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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