VEPPANU — FDA application NDA219835

Application NDA219835 · type NDA · FDA status: approved · original approval 2026-05-01

Listed sponsor: RIGEL PHARMS · RIGL 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	VEPPANU	VEPDEGESTRANT	TABLET	ORAL	100MG	Prescription	not listed	Yes
002	VEPPANU	VEPDEGESTRANT	TABLET	ORAL	200MG	Prescription	not listed	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 10899742	001	listed patent expiry date: 2037-12-01	U-4278
Patent 10899742	002	listed patent expiry date: 2037-12-01	U-4278
Patent 11597720	001	listed patent expiry date: 2037-12-01	drug substance, drug product, U-4278
Patent 11597720	002	listed patent expiry date: 2037-12-01	drug substance, drug product, U-4278
Patent 10647698	001	listed patent expiry date: 2038-01-30	drug substance, drug product
Patent 10647698	002	listed patent expiry date: 2038-01-30	drug substance, drug product
Exclusivity NCE	001	listed exclusivity date: 2031-05-01	FDA code as listed
Exclusivity NCE	002	listed exclusivity date: 2031-05-01	FDA code as listed

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

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.