Application 217242

Type: NDA
Sponsor: ARCUTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORYVE	ROFLUMILAST	FOAM;TOPICAL	0.3%	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
N217242-001	ZORYVE	ROFLUMILAST	0.3%	FOAM / TOPICAL		RLD, RS	2023-12-15

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217242-001	10940142	2037-06-07		Drug product	2023-12-26
N217242-001	11793796	2037-06-07		Drug product	2023-12-26
N217242-001	11819496	2037-06-07	U-3773		2023-12-26
N217242-001	11819496	2037-06-07	U-4203		2023-12-26
N217242-001	11992480	2037-06-07	U-3773		2024-06-26
N217242-001	11992480	2037-06-07	U-4203		2024-06-26
N217242-001	12005051	2037-06-07	U-3773		2024-07-10
N217242-001	12005051	2037-06-07	U-4203		2024-07-10
N217242-001	12005052	2037-06-07		Drug product	2024-07-10
N217242-001	12011437	2037-06-07		Drug product	2024-07-10
N217242-001	12016848	2037-06-07		Drug product	2024-07-10
N217242-001	12042487	2037-06-07		Drug product	2024-08-16
N217242-001	12220409	2037-06-07		Drug product	2025-03-07
N217242-001	12257242	2037-06-07		Drug product	2025-04-22
N217242-001	12310956	2037-06-07	U-3773		2025-06-26
N217242-001	12310956	2037-06-07	U-4203		2025-06-26
N217242-001	12336983	2037-06-07		Drug product	2025-07-22
N217242-001	12390453	2037-06-07		Drug product	2025-09-12
N217242-001	9884050	2037-06-07		Drug product	2023-12-26
N217242-001	9907788	2037-06-07	U-3773		2023-12-26
N217242-001	9907788	2037-06-07	U-4203		2023-12-26
N217242-001	11129818	2037-08-25	U-3773		2023-12-26
N217242-001	11129818	2037-08-25	U-4203		2023-12-26
N217242-001	11707454	2041-12-03	U-3773		2023-12-26
N217242-001	12329751	2041-12-03	U-3773		2025-07-17
N217242-001	12453721	2042-08-19		Drug product	2025-11-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217242-001	NP	2026-12-15
N217242-001	I-969	2028-05-22

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	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 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	N217242-001	10940142	2037-06-07		Drug product	2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11793796	2037-06-07		Drug product	2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11819496	2037-06-07	U-4203		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11819496	2037-06-07	U-3773		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11992480	2037-06-07	U-4203		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11992480	2037-06-07	U-3773		2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12005051	2037-06-07	U-4203		2024-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12005051	2037-06-07	U-3773		2024-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12005052	2037-06-07		Drug product	2024-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12011437	2037-06-07		Drug product	2024-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12016848	2037-06-07		Drug product	2024-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12042487	2037-06-07		Drug product	2024-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12220409	2037-06-07		Drug product	2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12257242	2037-06-07		Drug product	2025-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12310956	2037-06-07	U-3773		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12310956	2037-06-07	U-4203		2025-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12336983	2037-06-07		Drug product	2025-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12390453	2037-06-07		Drug product	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	9884050	2037-06-07		Drug product	2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	9907788	2037-06-07	U-4203		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	9907788	2037-06-07	U-3773		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11129818	2037-08-25	U-4203		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11129818	2037-08-25	U-3773		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	11707454	2041-12-03	U-3773		2023-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12329751	2041-12-03	U-3773		2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	12453721	2042-08-19		Drug product	2025-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	10940142	2037-06-07		Drug product	2023-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	11793796	2037-06-07		Drug product	2023-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	11819496	2037-06-07	U-4203		2023-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	11819496	2037-06-07	U-3773		2023-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	11992480	2037-06-07	U-4203		2024-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	11992480	2037-06-07	U-3773		2024-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12005051	2037-06-07	U-4203		2024-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12005051	2037-06-07	U-3773		2024-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12005052	2037-06-07		Drug product	2024-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12011437	2037-06-07		Drug product	2024-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12016848	2037-06-07		Drug product	2024-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12042487	2037-06-07		Drug product	2024-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12220409	2037-06-07		Drug product	2025-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	12257242	2037-06-07		Drug product	2025-04-22	`31067a03dcf5…`

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	N217242-001	NP	2026-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217242-001	I-969	2028-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	NP	2026-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217242-001	I-969	2028-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217242-001	NP	2026-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217242-001	I-969	2028-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217242-001	NP	2026-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217242-001	NP	2026-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217242-001	NP	2026-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217242-001	NP	2026-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217242-001	NP	2026-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217242-001	NP	2026-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217242-001	NP	2026-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217242-001	NP	2026-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217242-001	NP	2026-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217242-001	NP	2026-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217242-001	NP	2026-12-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217242-001	NP	2026-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217242-001	NP	2026-12-15	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217242-001	NP	2026-12-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217242-001	I-969	2028-05-22	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	f9e0b4a9-a227-4947-b00c-41fb18d16589	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217242 application number: NDA217242

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82436	SUPPL	2025-06-03
82317	SUPPL	2025-05-27
79551	SUPPL	2024-09-06
79548	SUPPL	2024-09-06
78205	ORIG	2024-04-23
77064	ORIG	2023-12-19
76874	ORIG	2023-12-15