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 42.

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
2026-08-18 06:07:40	2026-07	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`caaa826d4ba7…`
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 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217242-001	10940142	2037-06-07		Drug product	2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11793796	2037-06-07		Drug product	2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11819496	2037-06-07	U-4203		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11819496	2037-06-07	U-3773		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11992480	2037-06-07	U-4203		2024-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11992480	2037-06-07	U-3773		2024-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12005051	2037-06-07	U-4203		2024-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12005051	2037-06-07	U-3773		2024-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12005052	2037-06-07		Drug product	2024-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12011437	2037-06-07		Drug product	2024-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12016848	2037-06-07		Drug product	2024-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12042487	2037-06-07		Drug product	2024-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12220409	2037-06-07		Drug product	2025-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12257242	2037-06-07		Drug product	2025-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12310956	2037-06-07	U-3773		2025-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12310956	2037-06-07	U-4203		2025-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12336983	2037-06-07		Drug product	2025-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12390453	2037-06-07		Drug product	2025-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	9884050	2037-06-07		Drug product	2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	9907788	2037-06-07	U-4203		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	9907788	2037-06-07	U-3773		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11129818	2037-08-25	U-4203		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11129818	2037-08-25	U-3773		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	11707454	2041-12-03	U-3773		2023-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12329751	2041-12-03	U-3773		2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	12453721	2042-08-19		Drug product	2025-11-24	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N217242-001	NP	2026-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217242-001	I-969	2028-05-22	`caaa826d4ba7…`
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#

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
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