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 44.

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 · 27 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	12697329	2037-06-07		Drug product	2026-09-22
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
2026-10-15 13:18:30	2026-09	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217242-001	ZORYVE	0.3%	FOAM / TOPICAL	RLD, RS	2023-12-15	`84e616aacf4f…`
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 9 · 325 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N217242-001	10940142	2037-06-07		Drug product	2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11793796	2037-06-07		Drug product	2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11819496	2037-06-07	U-4203		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11819496	2037-06-07	U-3773		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11992480	2037-06-07	U-4203		2024-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11992480	2037-06-07	U-3773		2024-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12005051	2037-06-07	U-4203		2024-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12005051	2037-06-07	U-3773		2024-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12005052	2037-06-07		Drug product	2024-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12011437	2037-06-07		Drug product	2024-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12016848	2037-06-07		Drug product	2024-07-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12042487	2037-06-07		Drug product	2024-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12220409	2037-06-07		Drug product	2025-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12257242	2037-06-07		Drug product	2025-04-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12310956	2037-06-07	U-3773		2025-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12310956	2037-06-07	U-4203		2025-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12336983	2037-06-07		Drug product	2025-07-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12390453	2037-06-07		Drug product	2025-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12697329	2037-06-07		Drug product	2026-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	9884050	2037-06-07		Drug product	2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	9907788	2037-06-07	U-4203		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	9907788	2037-06-07	U-3773		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11129818	2037-08-25	U-4203		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11129818	2037-08-25	U-3773		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	11707454	2041-12-03	U-3773		2023-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12329751	2041-12-03	U-3773		2025-07-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	12453721	2042-08-19		Drug product	2025-11-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217242-001	10940142	2037-06-07		Drug product	2023-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	11793796	2037-06-07		Drug product	2023-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	11819496	2037-06-07	U-4203		2023-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	11819496	2037-06-07	U-3773		2023-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	11992480	2037-06-07	U-4203		2024-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	11992480	2037-06-07	U-3773		2024-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12005051	2037-06-07	U-4203		2024-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12005051	2037-06-07	U-3773		2024-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12005052	2037-06-07		Drug product	2024-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12011437	2037-06-07		Drug product	2024-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12016848	2037-06-07		Drug product	2024-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12042487	2037-06-07		Drug product	2024-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	12220409	2037-06-07		Drug product	2025-03-07	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N217242-001	NP	2026-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217242-001	I-969	2028-05-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217242-001	NP	2026-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217242-001	I-969	2028-05-22	`84e616aacf4f…`
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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROFLUMILAST	ROFLUMILAST	Amici Pharma Inc.	cb3781ff-5350-4f9a-b247-0b04eb0f2b92	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ZORYVE	ROFLUMILAST	Arcutis Biotherapeutics, Inc.	ec1bb0d1-f38a-4080-831a-68791d1d1fdb	2026-07-20	Adverse reactions	Name fallback brand name: ZORYVE generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Jubilant Cadista Pharmaceuticals Inc.	aaa81c1b-f63d-4e61-8bfa-9d42d92043c7	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
roflumilast	ROFLUMILAST	AvKARE	55009549-3f0c-1f58-e063-6294a90a6c03	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Major Pharmaceuticals	ca22f3e0-6f33-4f1c-97e5-0c962891067a	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	MAJOR PHARMACEUTICALS	c51b80f3-a591-4db9-81b4-b91603e35d7c	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Micro Labs Limited	dc2a689f-cfa4-4863-9623-a9813dcf86a9	2025-07-24	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Aurobindo Pharma Limited	7cb11d48-6bb9-437b-bc7f-382050a2d3e6	2025-05-27	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Golden State Medical Supply, Inc.	30dd6eae-6435-cae1-e063-6294a90a003b	2025-03-21	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Ascend Laboratories, LLC	93d72a99-64dc-4fde-a5b8-78331fa60787	2025-03-13	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	American Health Packaging	913f1b95-9c46-40d5-a6e9-cff2e5e07eaa	2024-11-21	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Novadoz Pharmaceuticals LLC	4d25f69c-58b7-4e2a-b835-4d0c76a83c7c	2024-08-27	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Zydus Pharmaceuticals USA Inc.	84145572-f320-4c3f-ab29-bd9f6c18746c	2024-08-16	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Bryant Ranch Prepack	fa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Zydus Lifesciences Limited	e87287bd-eae3-46c3-9072-04800aeabf40	2024-08-12		Name fallback generic name: ROFLUMILAST
Roflumilast	ROFLUMILAST	Camber Pharmaceuticals, Inc.	f25a0230-3cf6-4366-bebe-0ea5ff8de5ab	2023-04-28	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
ROFLUMILAST	ROFLUMILAST	Solco Healthcare US, LLC.	4251c764-7224-4f94-9de7-b6c76cb1f5cd	2022-05-10	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST
Daliresp	ROFLUMILAST	AstraZeneca Pharmaceuticals LP	c9a1d0a8-581f-4f91-a2b8-f419192d0ebf	2020-03-12	Warnings, Adverse reactions	Name fallback generic name: ROFLUMILAST

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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