FOUNDAYO — FDA application NDA220934

Application NDA220934 · type NDA · FDA status: approved · original approval 2026-04-01

Listed sponsor: ELI LILLY AND CO · LLY 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	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 0.8MG BASE	Prescription	not listed	Yes
002	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 2.5MG BASE	Prescription	not listed	Yes
003	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 5.5MG BASE	Prescription	not listed	Yes
004	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 9MG BASE	Prescription	not listed	Yes
005	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 14.5MG BASE	Prescription	not listed	Yes
006	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET	ORAL	EQ 17.2MG BASE	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 RE50455	001	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Patent RE50455	002	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Patent RE50455	003	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Patent RE50455	004	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Patent RE50455	005	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Patent RE50455	006	listed patent expiry date: 2037-09-26	drug substance, drug product, U-4474
Exclusivity NCE	001	listed exclusivity date: 2031-04-01	FDA code as listed
Exclusivity NCE	002	listed exclusivity date: 2031-04-01	FDA code as listed
Exclusivity NCE	003	listed exclusivity date: 2031-04-01	FDA code as listed
Exclusivity NCE	004	listed exclusivity date: 2031-04-01	FDA code as listed
Exclusivity NCE	005	listed exclusivity date: 2031-04-01	FDA code as listed
Exclusivity NCE	006	listed exclusivity date: 2031-04-01	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.

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.