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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 202834

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NDA 202834 describes FYCOMPA, which is a drug marketed by Catalyst Pharms and is included in two NDAs. It is available from two suppliers. There is one patent 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. Five suppliers are listed for this compound. Additional details are available on the perampanel profile page.

Summary for 202834

Tradename:	FYCOMPA
Applicant:	Catalyst Pharms
Ingredient:	perampanel
Patents:	1

Pharmacology for NDA: 202834

Mechanism of Action	AMPA Receptor Antagonists Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors

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	62856-272-14	14 TABLET in 1 PACKET (62856-272-14)
FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272	62856-272-30	30 TABLET in 1 BOTTLE (62856-272-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 22, 2012	TE:	AB	RLD:	Yes
Patent:	8,772,497	Patent Expiration:	Jul 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Oct 22, 2012	TE:	AB	RLD:	Yes
Patent:	8,772,497	Patent Expiration:	Jul 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Oct 22, 2012	TE:	AB	RLD:	Yes
Patent:	8,772,497	Patent Expiration:	Jul 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 202834

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012	6,949,571	⤷ Start Trial
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012	6,949,571	⤷ Start Trial
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	6,949,571	⤷ Start Trial
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012	6,949,571	⤷ Start Trial
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012	6,949,571	⤷ Start Trial
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	6,949,571	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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