Details for New Drug Application (NDA): 208277

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NDA 208277 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 208277

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

Pharmacology for NDA: 208277

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

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	62856-290-38	340 mL in 1 BOTTLE (62856-290-38)
FYCOMPA	perampanel	SUSPENSION;ORAL	208277	NDA	Catalyst Pharmaceuticals, Inc.	69616-290	69616-290-38	340 mL in 1 BOTTLE (69616-290-38)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	0.5MG/ML
Approval Date:	Apr 29, 2016	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Jul 1, 2026	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208277

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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