Application 215272

Type: NDA
Sponsor: DERMAVANT SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VTAMA	TAPINAROF	CREAM;TOPICAL	1%	Yes	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
N215272-001	VTAMA	TAPINAROF	1%	CREAM / TOPICAL		RLD, RS	2022-05-23

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215272-001	10426743	2036-05-19	U-2625		2022-06-21
N215272-001	10426743	2036-05-19	U-4048		2022-06-21
N215272-001	11458108	2036-05-19		Drug product	2022-10-07
N215272-001	11612573	2036-05-19	U-2625		2023-04-20
N215272-001	11612573	2036-05-19	U-4048		2023-04-20
N215272-001	11617724	2036-05-19		Drug product	2023-04-20
N215272-001	11622945	2036-05-19		Drug product	2023-04-20
N215272-001	10195160	2036-05-23		Drug product	2022-06-21
N215272-001	10647649	2038-11-13		Drug substance	2022-06-21
N215272-001	11597692	2038-11-13		Drug substance, Drug product	2023-03-31
N215272-001	11497718	2039-11-13	U-4048		2025-01-10
N215272-001	11590088	2039-11-13	U-2625		2023-03-16
N215272-001	11938099	2039-11-13	U-4048		2025-01-10
N215272-001	12569453	2039-12-18	U-4048		2026-04-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215272-001	NCE	2027-05-23
N215272-001	I-956	2027-12-12

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	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215272-001	VTAMA	1%	CREAM / TOPICAL	RLD, RS	2022-05-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 247 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	N215272-001	10195160	2036-05-19		Drug product	2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	10426743	2036-05-19	U-4048		2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	10426743	2036-05-19	U-2625		2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11458108	2036-05-19		Drug product	2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11612573	2036-05-19	U-4048		2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11612573	2036-05-19	U-2625		2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11617724	2036-05-19		Drug product	2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11622945	2036-05-19		Drug product	2023-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	10647649	2038-11-13		Drug substance	2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11597692	2038-11-13		Drug substance, Drug product	2023-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11497718	2039-11-13	U-4048		2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11590088	2039-11-13	U-2625		2023-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	11938099	2039-11-13	U-4048		2025-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	10195160	2036-05-19		Drug product	2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	10426743	2036-05-19	U-4048		2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	10426743	2036-05-19	U-2625		2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11458108	2036-05-19		Drug product	2022-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11612573	2036-05-19	U-4048		2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11612573	2036-05-19	U-2625		2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11617724	2036-05-19		Drug product	2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11622945	2036-05-19		Drug product	2023-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	10647649	2038-11-13		Drug substance	2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11597692	2038-11-13		Drug substance, Drug product	2023-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11497718	2039-11-13	U-4048		2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11590088	2039-11-13	U-2625		2023-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	11938099	2039-11-13	U-4048		2025-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215272-001	10195160	2036-05-19		Drug product	2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	10426743	2036-05-19	U-4048		2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	10426743	2036-05-19	U-2625		2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11458108	2036-05-19		Drug product	2022-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11612573	2036-05-19	U-4048		2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11612573	2036-05-19	U-2625		2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11617724	2036-05-19		Drug product	2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11622945	2036-05-19		Drug product	2023-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	10647649	2038-11-13		Drug substance	2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11597692	2038-11-13		Drug substance, Drug product	2023-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11497718	2039-11-13	U-4048		2025-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11590088	2039-11-13	U-2625		2023-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	11938099	2039-11-13	U-4048		2025-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215272-001	10195160	2036-05-19		Drug product	2022-06-21	`fd3edfee7708…`

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	N215272-001	NCE	2027-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215272-001	I-956	2027-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	NCE	2027-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215272-001	I-956	2027-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215272-001	NCE	2027-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215272-001	I-956	2027-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215272-001	NCE	2027-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215272-001	I-956	2027-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215272-001	NCE	2027-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215272-001	I-956	2027-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215272-001	NCE	2027-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215272-001	NCE	2027-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215272-001	NCE	2027-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215272-001	NCE	2027-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215272-001	NCE	2027-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215272-001	NCE	2027-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215272-001	NCE	2027-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215272-001	NCE	2027-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215272-001	NCE	2027-05-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215272-001	NCE	2027-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215272-001	NCE	2027-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215272-001	NCE	2027-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215272-001	NCE	2027-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215272-001	NCE	2027-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215272-001	NCE	2027-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215272-001	NCE	2027-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215272-001	NCE	2027-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215272-001	NCE	2027-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215272-001	NCE	2027-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215272-001	NCE	2027-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215272-001	NCE	2027-05-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215272-001	NCE	2027-05-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215272-001	NCE	2027-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215272-001	I-956	2027-12-12	`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
VTAMA	TAPINAROF	Organon LLC	9309d20f-8cd4-4c96-93fa-7f730e83c7ab	2025-05-28	Adverse reactions	Exact identifier application applno (NDA): 215272 application number: NDA215272 ndc (product): 81672-5051

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
81672-5051	VTAMA	tapinarof	Dermavant Sciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80571	SUPPL	2024-12-18
80587	SUPPL	2024-12-16
71399	ORIG	2022-06-21
71139	ORIG	2022-05-24
71136	ORIG	2022-05-24