Application 214755

Type: NDA
Sponsor: AVADEL CNS PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUMRYZ	SODIUM OXYBATE	SUSPENSION;ORAL	4.5G	No	No
002	LUMRYZ	SODIUM OXYBATE	SUSPENSION;ORAL	6G	No	No
003	LUMRYZ	SODIUM OXYBATE	SUSPENSION;ORAL	7.5G	No	No
004	LUMRYZ	SODIUM OXYBATE	SUSPENSION;ORAL	9G	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214755-001	LUMRYZ	SODIUM OXYBATE	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01
N214755-002	LUMRYZ	SODIUM OXYBATE	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01
N214755-003	LUMRYZ	SODIUM OXYBATE	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01
N214755-004	LUMRYZ	SODIUM OXYBATE	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01

Orange Book patents#

Current patent rows page 1 of 2 · 113 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214755-001	10272062	2037-07-21		Drug product	2023-05-23
N214755-001	10736866	2037-07-21		Drug product	2023-05-23
N214755-001	10952986	2037-07-21	U-3601		2023-05-23
N214755-001	10973795	2037-07-21		Drug product	2023-05-23
N214755-001	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-001	11052061	2037-07-21		Drug product	2023-05-23
N214755-001	11065224	2037-07-21		Drug product	2023-05-23
N214755-001	11400065	2037-07-21	U-3579		2023-05-23
N214755-001	11504347	2037-07-21		Drug product	2023-05-23
N214755-001	11602512	2037-07-21	U-3577		2023-05-23
N214755-001	11602513	2037-07-21	U-3576		2023-05-23
N214755-001	11766418	2037-07-21		Drug product	2023-09-29
N214755-001	11839597	2037-07-21		Drug product	2024-01-04
N214755-001	11896572	2037-07-21		Drug product	2024-02-20
N214755-001	11986451	2037-07-21	U-3934		2024-05-29
N214755-001	12097175	2037-07-21		Drug product	2024-10-15
N214755-001	12097176	2037-07-21	U-4006		2024-10-15
N214755-001	12109186	2037-07-21		Drug product	2024-10-15
N214755-001	12115142	2037-07-21		Drug product	2024-10-22
N214755-001	12115143	2037-07-21		Drug product	2024-10-22
N214755-001	12115144	2037-07-21		Drug product	2024-10-22
N214755-001	12115145	2037-07-21		Drug product	2024-10-22
N214755-001	12128021	2037-07-21	U-4022		2024-11-12
N214755-001	12138239	2037-07-21		Drug product	2024-11-15
N214755-001	12144793	2037-07-21		Drug product	2024-11-22
N214755-001	12303478	2037-07-21	U-4189		2025-06-02
N214755-001	11583510	2042-02-07	U-3578		2023-05-23
N214755-001	11779557	2042-03-16	U-3705		2023-10-24
N214755-002	10272062	2037-07-21		Drug product	2023-05-23
N214755-002	10736866	2037-07-21		Drug product	2023-05-23
N214755-002	10952986	2037-07-21	U-3601		2023-05-23
N214755-002	10973795	2037-07-21		Drug product	2023-05-23
N214755-002	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-002	11052061	2037-07-21		Drug product	2023-05-23
N214755-002	11065224	2037-07-21		Drug product	2023-05-23
N214755-002	11400065	2037-07-21	U-3579		2023-05-23
N214755-002	11504347	2037-07-21		Drug product	2023-05-23
N214755-002	11602512	2037-07-21	U-3577		2023-05-23
N214755-002	11602513	2037-07-21	U-3576		2023-05-23
N214755-002	11766418	2037-07-21		Drug product	2023-09-29
N214755-002	11826335	2037-07-21	U-3751		2023-12-04
N214755-002	11839597	2037-07-21		Drug product	2024-01-04
N214755-002	11896572	2037-07-21		Drug product	2024-02-20
N214755-002	11986451	2037-07-21	U-3934		2024-05-29
N214755-002	12097175	2037-07-21		Drug product	2024-10-15
N214755-002	12097176	2037-07-21	U-4006		2024-10-15
N214755-002	12109186	2037-07-21		Drug product	2024-10-15
N214755-002	12115142	2037-07-21		Drug product	2024-10-22
N214755-002	12115143	2037-07-21		Drug product	2024-10-22
N214755-002	12115144	2037-07-21		Drug product	2024-10-22
N214755-002	12115145	2037-07-21		Drug product	2024-10-22
N214755-002	12128021	2037-07-21	U-4022		2024-11-12
N214755-002	12138239	2037-07-21		Drug product	2024-11-15
N214755-002	12144793	2037-07-21		Drug product	2024-11-22
N214755-002	12303478	2037-07-21	U-4189		2025-06-02
N214755-002	11583510	2042-02-07	U-3578		2023-05-23
N214755-002	11779557	2042-03-16	U-3705		2023-10-24
N214755-003	10272062	2037-07-21		Drug product	2023-05-23
N214755-003	10736866	2037-07-21		Drug product	2023-05-23
N214755-003	10952986	2037-07-21	U-3601		2023-05-23
N214755-003	10973795	2037-07-21		Drug product	2023-05-23
N214755-003	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-003	11052061	2037-07-21		Drug product	2023-05-23
N214755-003	11065224	2037-07-21		Drug product	2023-05-23
N214755-003	11400065	2037-07-21	U-3579		2023-05-23
N214755-003	11504347	2037-07-21		Drug product	2023-05-23
N214755-003	11602512	2037-07-21	U-3577		2023-05-23
N214755-003	11602513	2037-07-21	U-3576		2023-05-23
N214755-003	11766418	2037-07-21		Drug product	2023-09-29
N214755-003	11839597	2037-07-21		Drug product	2024-01-04
N214755-003	11896572	2037-07-21		Drug product	2024-02-20
N214755-003	11986451	2037-07-21	U-3934		2024-05-29
N214755-003	12097175	2037-07-21		Drug product	2024-10-15
N214755-003	12097176	2037-07-21	U-4006		2024-10-15
N214755-003	12109186	2037-07-21		Drug product	2024-10-15
N214755-003	12115142	2037-07-21		Drug product	2024-10-22
N214755-003	12115143	2037-07-21		Drug product	2024-10-22
N214755-003	12115144	2037-07-21		Drug product	2024-10-22
N214755-003	12115145	2037-07-21		Drug product	2024-10-22
N214755-003	12128021	2037-07-21	U-4022		2024-11-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214755-001	NP	2026-05-01
N214755-001	ODE-431	2030-05-01
N214755-001	ODE-494	2031-10-16
N214755-002	NP	2026-05-01
N214755-002	ODE-431	2030-05-01
N214755-002	ODE-494	2031-10-16
N214755-003	NP	2026-05-01
N214755-003	ODE-431	2030-05-01
N214755-003	ODE-494	2031-10-16
N214755-004	NP	2026-05-01
N214755-004	ODE-431	2030-05-01
N214755-004	ODE-494	2031-10-16

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.

Product history page 1 of 3 · 88 observed 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	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,881 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	N214755-001	10272062	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10736866	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10952986	2037-07-21	U-3601		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10973795	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11052061	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11065224	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11400065	2037-07-21	U-3579		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11504347	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11602512	2037-07-21	U-3577		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11602513	2037-07-21	U-3576		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11766418	2037-07-21		Drug product	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11839597	2037-07-21		Drug product	2024-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11896572	2037-07-21		Drug product	2024-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11986451	2037-07-21	U-3934		2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12097175	2037-07-21		Drug product	2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12097176	2037-07-21	U-4006		2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12109186	2037-07-21		Drug product	2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115142	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115143	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115144	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115145	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12128021	2037-07-21	U-4022		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12138239	2037-07-21		Drug product	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12144793	2037-07-21		Drug product	2024-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12226377	2037-07-21		Drug product	2025-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12303478	2037-07-21	U-4189		2025-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10925844	2040-02-28		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11583510	2042-02-07	U-3578		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11779557	2042-03-16	U-3705		2023-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10272062	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10736866	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10952986	2037-07-21	U-3601		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10973795	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11052061	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11065224	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11400065	2037-07-21	U-3579		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11504347	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11602512	2037-07-21	U-3577		2023-05-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 212 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214755-001	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	ODE-494	2031-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	ODE-494	2031-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214755-001	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-001	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-001	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	NP	2026-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	ODE-431	2030-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	ODE-494	2031-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-002	NP	2026-05-01	`fd3edfee7708…`

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
Lumryz	SODIUM OXYBATE	Avadel CNS Pharmaceuticals, LLC	10e5e40c-52f3-4c73-8a34-2c29c690a934	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214755 application number: NDA214755

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84209	SUPPL	2025-11-19
81540	SUPPL	2025-03-12
80657	SUPPL	2024-12-20
80488	SUPPL	2024-12-04
79944	SUPPL	2024-10-21
79943	SUPPL	2024-10-21
79910	SUPPL	2024-10-17
79756	SUPPL	2024-09-27
79751	SUPPL	2024-09-26
77203	SUPPL	2024-01-11
74154	ORIG	2023-11-07
76031	SUPPL	2023-11-02
76005	ORIG	2023-10-31
74150	ORIG	2023-05-02
71622	ORIG	2022-07-25