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Generated: November 20, 2018

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Details for New Drug Application (NDA): 202834

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NDA 202834 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 202834
Tradename:FYCOMPA
Applicant:Eisai Inc
Ingredient:perampanel
Patents:2
Generic Entry Opportunity Date for 202834
Generic Entry Date for 202834*:
Constraining patent/regulatory exclusivity:
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 NDA: 202834
Mechanism of ActionAMPA Receptor Antagonists
Suppliers and Packaging for NDA: 202834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FYCOMPA perampanel TABLET;ORAL 202834 NDA Eisai Inc. 62856-272 62856-272-30 30 TABLET in 1 BOTTLE (62856-272-30)
FYCOMPA perampanel TABLET;ORAL 202834 NDA Eisai Inc. 62856-272 62856-272-90 90 TABLET in 1 BOTTLE (62856-272-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 22, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 19, 2018
Regulatory Exclusivity Use:ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC (PG TC) SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER.
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

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