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Perampanelis 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.
Recent Clinical Trials for perampanel
Identify potential brand extensions & 505(b)(2) entrants
|National Cancer Institute (NCI)||Phase 4|
|Mayo Clinic||Phase 4|
|Kimford Jay Meador||Phase 4|
Generic filers with tentative approvals for PERAMPANEL
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
|Drug Class||Noncompetitive AMPA Glutamate Receptor Antagonist |
|Mechanism of Action||AMPA Receptor Antagonists |
|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||202834-003||Oct 22, 2012||RX||Yes||No||Start Trial||Start Trial||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||202834-005||Oct 22, 2012||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Eisai Inc||FYCOMPA||perampanel||TABLET;ORAL||202834-006||Oct 22, 2012||RX||Yes||Yes||Start Trial||Start Trial||Y||Y||Start Trial|
|Eisai Inc||FYCOMPA||perampanel||TABLET;ORAL||202834-001||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|
|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|
|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|
|1300396||300566||Netherlands||Start Trial||PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723|
|1764361||PA2013017,C1764361||Lithuania||Start Trial||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|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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