Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Colorcon
Cantor Fitzgerald
UBS
Harvard Business School
Queensland Health
Johnson and Johnson
QuintilesIMS

Generated: July 23, 2018

DrugPatentWatch Database Preview

FYCOMPA Drug Profile

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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
International Patents:99
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 46
Clinical Trials: 8
Patent Applications: 56
DailyMed Link:FYCOMPA at DailyMed
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 Y ➤ Sign Up
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-006 Oct 22, 2012 RX Yes Yes ➤ 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 ➤ Sign Up
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

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

Non-Orange Book US Patents for 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
7,563,811 1,2-dihydropyridine compounds, manufacturing method thereof and use thereof ➤ Sign Up
8,304,548 Method for producing 1, 2-dihydropyridine-2-one compound ➤ Sign Up
9,045,426 Method for producing 1,2-dihydropyridine-2-one compound ➤ Sign Up
7,939,549 1,2-dihydropyridine compounds, manufacturing method thereof and use thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

see a sample report or, see our see our flat-rate plans

Supplementary Protection Certificates for FYCOMPA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3 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
90045-2 Sweden ➤ Sign Up PRODUCT NAME: PERAMPANEL OCH SALTER OCH HYDRATER DAERAV; REG. NO/DATE: EU/1/12/776/001 20120723
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
113 Luxembourg ➤ Sign Up PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Cipla
Citi
Colorcon
Moodys
Harvard Business School
UBS
Farmers Insurance
US Department of Justice

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.