Application 215973

Type: NDA
Sponsor: GILEAD SCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUNLENCA	LENACAPAVIR	INJECTABLE;INJECTION	300MG	No	No

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
N215973-001	SUNLENCA	LENACAPAVIR SODIUM	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2022-12-22

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
N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18
N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18
N215973-001	10654827	2037-08-17	U-3507		2023-01-18
N215973-001	11267799	2038-08-16		Drug substance	2023-01-18
N215973-001	12594267	2039-07-15		Drug product	2026-04-21
N215973-001	11944611	2041-08-28	U-3507		2024-04-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215973-001	NCE	2027-12-22

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	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 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	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	11944611	2041-06-04	U-3507		2024-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	11944611	2041-06-04	U-3507		2024-04-23	`5bbf6a4d5a75…`

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	N215973-001	NCE	2027-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	NCE	2027-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	NCE	2027-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	NCE	2027-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	NCE	2027-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	NCE	2027-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	NCE	2027-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	NCE	2027-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215973-001	NCE	2027-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215973-001	NCE	2027-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215973-001	NCE	2027-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215973-001	NCE	2027-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215973-001	NCE	2027-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215973-001	NCE	2027-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215973-001	NCE	2027-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215973-001	NCE	2027-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215973-001	NCE	2027-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215973-001	NCE	2027-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215973-001	NCE	2027-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215973-001	NCE	2027-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215973-001	NCE	2027-12-22	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215973-001	NCE	2027-12-22	`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
Sunlenca	LENACAPAVIR SODIUM	Gilead Sciences, Inc.	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215973 application number: NDA215973 ndc (product): 61958-3002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-3002	Sunlenca	LENACAPAVIR SODIUM	Gilead Sciences	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85378	SUPPL	2026-03-16
80434	SUPPL	2024-11-26
80420	SUPPL	2024-11-26
79137	SUPPL	2024-07-22
79116	SUPPL	2024-07-18
73383	ORIG	2023-02-06
73028	ORIG	2022-12-23
73001	ORIG	2022-12-22