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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208277

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NDA 208277 describes FYCOMPA, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FYCOMPA profile page.

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 208277
Tradename:FYCOMPA
Applicant:Eisai Inc
Ingredient:perampanel
Patents:2
Pharmacology for NDA: 208277
Mechanism of ActionAMPA Receptor Antagonists
Suppliers and Packaging for NDA: 208277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FYCOMPA perampanel SUSPENSION;ORAL 208277 NDA Eisai Inc. 62856-290 N 62856-290-38

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength0.5MG/ML
Approval Date:Apr 29, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF EPILEPSY
Patent:➤ Sign UpPatent Expiration:Jun 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY
Patent:➤ Sign UpPatent Expiration:Jun 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY

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