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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 Institute of Mental Health (NIMH)||Phase 1|
|Assistance Publique Hopitaux De Marseille||N/A|
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 |
Synonyms 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|
|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|
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