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Generated: March 19, 2019

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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 ninety-nine patent family members in thirty-two 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 FYCOMPA
Drug patent expirations by year 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.

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

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 TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-004 Oct 22, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for FYCOMPA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for FYCOMPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 2013C/003 Belgium ➤ Sign Up PRODUCT NAME: FYCOMPA-PERAMPANEL; AUTHORISATION NUMBER AND DATE: EU/1/12/776/001 20120723
1764361 C20130021 00081 Estonia ➤ Sign Up PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1764361 173 5-2013 Slovakia ➤ Sign Up PRODUCT 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
1300396 92113 Luxembourg ➤ Sign Up PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1300396 300565 Netherlands ➤ Sign Up PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
1300396 420 Finland ➤ Sign Up
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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