VEMLIDY — FDA application NDA208464

Application NDA208464 · type NDA · FDA status: approved · original approval 2016-11-10

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	VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	TABLET	ORAL	EQ 25MG BASE	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 8754065	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-999
Patent 8754065	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-1275
Patent 8754065	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-3880
Patent 9296769	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-1275
Patent 9296769	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-3880
Patent 9296769	001	listed patent expiry date: 2032-08-15	drug substance, drug product, U-999
Patent 8754065	001	listed patent expiry date: 2033-02-15	pediatric extension
Patent 9296769	001	listed patent expiry date: 2033-02-15	pediatric extension
Exclusivity NPP	001	listed exclusivity date: 2027-03-27	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.

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.