Application 217899

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIVDELZI	SELADELPAR LYSINE	CAPSULE;ORAL	EQ 10MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217899-001	LIVDELZI	SELADELPAR LYSINE	EQ 10MG BASE	CAPSULE / ORAL		RLD, RS	2024-08-14

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217899-001	7301050	2026-08-02		Drug substance, Drug product	2024-08-30
N217899-001	7709682	2026-09-13		Drug substance	2024-08-30
N217899-001	10272058	2035-03-19	U-1854		2024-08-30
N217899-001	11406611	2035-03-19	U-1854		2024-08-30
N217899-001	11596614	2035-03-19	U-1854		2024-08-30
N217899-001	9486428	2035-03-19	U-1854		2024-08-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217899-001	NCE	2029-08-14
N217899-001	ODE-486	2031-08-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217899-001	LIVDELZI	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2024-08-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217899-001	7301050	2026-08-02		Drug substance, Drug product	2024-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	7301050	2026-08-02		Drug substance, Drug product	2024-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217899-001	7301050	2025-08-02		Drug substance, Drug product	2024-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	7301050	2025-08-02		Drug substance, Drug product	2024-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	7301050	2025-08-02		Drug substance, Drug product	2024-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	7301050	2025-08-02		Drug substance, Drug product	2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	11596614	2035-03-19	U-1854		2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	9486428	2035-03-19	U-1854		2024-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	7301050	2025-08-02		Drug substance, Drug product	2024-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	7709682	2026-09-13		Drug substance	2024-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	10272058	2035-03-19	U-1854		2024-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	11406611	2035-03-19	U-1854		2024-08-30	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217899-001	NCE	2029-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217899-001	ODE-486	2031-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	NCE	2029-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217899-001	ODE-486	2031-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217899-001	NCE	2029-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217899-001	ODE-486	2031-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	NCE	2029-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217899-001	ODE-486	2031-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	NCE	2029-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217899-001	ODE-486	2031-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	NCE	2029-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217899-001	ODE-486	2031-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	NCE	2029-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217899-001	ODE-486	2031-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217899-001	NCE	2029-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217899-001	NCE	2029-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217899-001	ODE-486	2031-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217899-001	NCE	2029-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217899-001	ODE-486	2031-08-14	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217899-001	NCE	2029-08-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217899-001	ODE-486	2031-08-14	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Livdelzi	SELADELPAR LYSINE	Gilead Sciences, Inc	89f79d98-135c-40b2-a585-6996c04e599c	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217899 application number: NDA217899

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84948	SUPPL	2026-02-05
84898	SUPPL	2026-02-03
79629	ORIG	2024-09-16
79413	ORIG	2024-08-16
79400	ORIG	2024-08-14