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Last Updated: February 25, 2020

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FYCOMPA Drug Profile


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When do Fycompa patents expire, 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 one hundred and one patent family members in thirty-three 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.

US ANDA Litigation and Generic Entry Outlook for Fycompa

Fycompa was eligible for patent challenges on October 22, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2026. 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.

There are two tentative approvals for the generic drug (perampanel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for FYCOMPA
Drug patent expirations by year for FYCOMPA
Drug Prices for FYCOMPA

See drug prices for FYCOMPA

Generic Entry Opportunity Date for FYCOMPA
Generic Entry Dates for FYCOMPA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;ORAL
Generic Entry Dates for FYCOMPA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 FYCOMPA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mayo ClinicEarly Phase 1
University of ArizonaPhase 4
Eisai Co., Ltd.Phase 3

See all FYCOMPA clinical trials

Pharmacology for FYCOMPA
Synonyms for FYCOMPA
2-(2-oxo-1-phenyl-5-pyridin-2-ylpyridin-3-yl)benzonitrile
2-(6-Oxo-1-phenyl-1,6-dihydro-[2,3-bipyridin]-5-yl)benzonitrile
2-(6'-Oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile
2-(6'-oxo-1'-phenyl-1',6'-dihydro-2,3'-bipyridin-5'-yl)benzonitrile
2-(6'-Oxo-1'-Phenyl[1',6'-Dihydro[2,3'-Bipyridine]]-5'-Yl)benzonitrile
3-(2-Cyanophenyl)-1-phenyl-5-(2-pyridyl)-1,2-dihydropyridin-2-one
3-(2-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one
380917-97-5
3964AH
6ZP
AC-27375
AKOS016340421
AM806751
AOB87762
BC261877
BCP06505
BDBM50184410
Benzonitrile, 2-(1',6'-dihydro-6'-oxo-1'-phenyl(2,3'-bipyridin)-5'-yl)-
Benzonitrile, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-
C23H15N3O
CH-0056
CHEBI:71013
CHEMBL1214124
CS-1160
CTK1B5138
D08964
DB08883
DTXSID80191501
E 2007
E-2007
E2007
ER 155055-90
ER-155055-90
EX-A2128
Fycompa (TN)
GTPL7050
H821664NPK
HY-14745
KS-00000XJ4
MolPort-035-395-270
NCGC00378863-02
Perampane
Perampanel
Perampanel (USAN)
Perampanel [USAN:INN]
Perampanel(E2007 pound(c)
perampanelum
PRMWGUBFXWROHD-UHFFFAOYSA-N
SB16816
SCHEMBL194370
ST24039511
UNII-H821664NPK
W-5817
ZINC30691797
Paragraph IV (Patent) Challenges for FYCOMPA
Tradename Dosage Ingredient NDA Submissiondate
FYCOMPA TABLET;ORAL perampanel 202834 2016-10-24

US Patents and Regulatory Information for 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;ORAL 208277-001 Apr 29, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-002 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for FYCOMPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1764361 C20130021 00081 Estonia   Start Trial PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1300396 420 Finland   Start Trial
1764361 C 2013 025 Romania   Start Trial PRODUCT NAME: PERAMPANEL3-(2-CIANOFENIL)-5-(2-PIRIDIL)-1-FENIL-1,2-DIHIDROPIRIDIN-2-ONA; NATIONAL AUTHORISATION NUMBER: EU/1/12/776/001 - EU/1/12/776/023; DATE OF NATIONAL AUTHORISATION: 20120723; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/776/001 - EU/1/12/776/023; DATE OF FIRST AUTHORISATION IN EEA: 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
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Mallinckrodt
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Dow
Medtronic

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