ZYDELIG — FDA application NDA205858

Application NDA205858 · type NDA · FDA status: approved · original approval 2014-07-23

Listed sponsor: GILEAD SCIENCES INC · GILD 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	ZYDELIG	IDELALISIB	TABLET	ORAL	100MG	Prescription	AB	Yes
002	ZYDELIG	IDELALISIB	TABLET	ORAL	150MG	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 9492449	001	listed patent expiry date: 2030-03-11	U-1914
Patent 9492449	002	listed patent expiry date: 2030-03-11	U-1914
Patent 10730879	001	listed patent expiry date: 2033-03-05	drug substance, drug product
Patent 10730879	002	listed patent expiry date: 2033-03-05	drug substance, drug product
Patent 8865730	001	listed patent expiry date: 2033-03-05	drug substance, drug product, U-1615
Patent 8865730	002	listed patent expiry date: 2033-03-05	drug substance, drug product, U-1615
Patent 9469643	001	listed patent expiry date: 2033-09-02	drug substance
Patent 9469643	002	listed patent expiry date: 2033-09-02	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.

IDELALISIB · UNII YG57I8T5M0 · lmmol compound IFSDAJWBUCMOAH-HNNXBMFYSA-N · CHEMBL2216870

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

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.