FYCOMPA — FDA application NDA202834

Application NDA202834 · type NDA · FDA status: approved · original approval 2012-10-22

Listed sponsor: CATALYST PHARMS · CPRX company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	FYCOMPA	PERAMPANEL	TABLET	ORAL	2MG	Prescription	AB	Yes
002	FYCOMPA	PERAMPANEL	TABLET	ORAL	4MG	Prescription	AB	Yes
003	FYCOMPA	PERAMPANEL	TABLET	ORAL	6MG	Prescription	AB	Yes
004	FYCOMPA	PERAMPANEL	TABLET	ORAL	8MG	Prescription	AB	Yes
005	FYCOMPA	PERAMPANEL	TABLET	ORAL	10MG	Prescription	AB	Yes
006	FYCOMPA	PERAMPANEL	TABLET	ORAL	12MG	Prescription	AB	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 8772497	001	listed patent expiry date: 2026-07-01	drug substance
Patent 8772497	002	listed patent expiry date: 2026-07-01	drug substance
Patent 8772497	003	listed patent expiry date: 2026-07-01	drug substance
Patent 8772497	004	listed patent expiry date: 2026-07-01	drug substance
Patent 8772497	005	listed patent expiry date: 2026-07-01	drug substance
Patent 8772497	006	listed patent expiry date: 2026-07-01	drug substance

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

PERAMPANEL · UNII H821664NPK · lmmol compound PRMWGUBFXWROHD-UHFFFAOYSA-N · CHEMBL1214124

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.