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Generated: January 22, 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-yl-pyridin-3-yl)benzonitrile
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
AK162257
AKOS016340421
AM806751
AOB87762
BC261877
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
D0U3ED
DB08883
DTXSID80191501
E 2007
E-2007
E2007
ER 155055-90
ER-155055-90
Fycompa (TN)
GTPL7050
H821664NPK
HE063783
HE339796
HY-14745
KS-00000XJ4
MFCD19443693
MolPort-035-395-270
Perampane
Perampanel
Perampanel (USAN)
Perampanel [USAN:INN]
Perampanel(E2007 pound(c)
perampanelum
PRMWGUBFXWROHD-UHFFFAOYSA-N
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
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-006 Oct 22, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0565 Netherlands ➤ Sign Up PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
2013017 Lithuania ➤ Sign Up PRODUCT 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
12/049 Ireland ➤ Sign Up PRODUCT NAME: PERAMPANEL, OPTIONALLY A SALT OR HYDRATE THEREOF.; REGISTRATION NO/DATE: EU/1/12/776/001-EU/1/12/776/016 20120723
2012 00052 Denmark ➤ Sign Up
C/GB12/057 United Kingdom ➤ Sign Up PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
1300396/01 Switzerland ➤ Sign Up PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
113 Luxembourg ➤ Sign Up PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Baxter
US Army
Cantor Fitzgerald
Merck
Johnson and Johnson
AstraZeneca
Accenture
UBS

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