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Last Updated: March 28, 2020

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Perampanel - Generic Drug Details

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What are the generic sources for perampanel and what is the scope of patent protection?

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

Perampanel has one hundred and one patent family members in thirty-three countries.

There are five drug master file entries for perampanel. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for perampanel
International Patents:101
US Patents:2
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 5
Suppliers / Packagers: 1
Bulk Api Vendors: 51
Clinical Trials: 56
Patent Applications: 115
DailyMed Link:perampanel at DailyMed
Recent Clinical Trials for perampanel

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

SponsorPhase
Carilion ClinicN/A
National Institute of Mental Health (NIMH)Phase 1
Assistance Publique Hopitaux De MarseilleN/A

See all perampanel clinical trials

Generic filers with tentative approvals for PERAMPANEL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial8MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for perampanel
Synonyms for perampanel
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'-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
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
Fycompa (TN)
GTPL7050
H821664NPK
HY-14745
KS-00000XJ4
NCGC00378863-02
Perampane
Perampanel (USAN)
Perampanel [USAN:INN]
Perampanel(E2007 pound(c)
perampanelum
PRMWGUBFXWROHD-UHFFFAOYSA-N
Q868658
SB16816
SCHEMBL194370
ST24039511
UNII-H821664NPK
W-5817
ZINC30691797
Paragraph IV (Patent) Challenges for PERAMPANEL
Tradename Dosage Ingredient NDA Submissiondate
FYCOMPA TABLET;ORAL perampanel 202834 2016-10-24

US Patents and Regulatory Information for perampanel

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 202834-004 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Eisai Inc FYCOMPA perampanel SUSPENSION;ORAL 208277-001 Apr 29, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eisai Inc FYCOMPA perampanel TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No   Start Trial   Start Trial Y 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 perampanel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 12C0074 France   Start Trial PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
1300396 CA 2012 00052 Denmark   Start Trial
1300396 C300566 Netherlands   Start Trial PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Colorcon
Baxter
Boehringer Ingelheim
Moodys

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 verification 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.