Application 210797

Type: NDA
Sponsor: CLIVUNEL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SCENESSE	AFAMELANOTIDE	IMPLANT;SUBCUTANEOUS	16MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N210797-001	SCENESSE	AFAMELANOTIDE	16MG	IMPLANT / SUBCUTANEOUS		RLD, RS	2019-10-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210797-001	8334265	2033-01-20	U-2638		2019-11-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210797-001	ODE-270	2026-10-08

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210797-001	SCENESSE	16MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2019-10-08	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210797-001	8334265	2033-01-20	U-2638	2019-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210797-001	8334265	2033-01-20	U-2638	2019-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210797-001	8334265	2033-01-20	U-2638	2019-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210797-001	8334265	2033-01-20	U-2638	2019-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210797-001	8334265	2033-01-20	U-2638	2019-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210797-001	8334265	2029-03-11	U-2638	2019-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210797-001	10076555	2025-02-11	U-2638	2019-11-06	`87673890dc5c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N210797-001	ODE-270	2026-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210797-001	ODE-270	2026-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210797-001	ODE-270	2026-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210797-001	ODE-270	2026-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210797-001	ODE-270	2026-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210797-001	ODE-270	2026-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210797-001	ODE-270	2026-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210797-001	NCE	2024-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210797-001	ODE-270	2026-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210797-001	NCE	2024-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210797-001	ODE-270	2026-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210797-001	NCE	2024-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210797-001	ODE-270	2026-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210797-001	NCE	2024-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210797-001	ODE-270	2026-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210797-001	NCE	2024-10-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210797-001	ODE-270	2026-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210797-001	NCE	2024-10-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210797-001	ODE-270	2026-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210797-001	NCE	2024-10-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210797-001	ODE-270	2026-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210797-001	NCE	2024-10-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210797-001	ODE-270	2026-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210797-001	NCE	2024-10-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210797-001	ODE-270	2026-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210797-001	NCE	2024-10-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210797-001	ODE-270	2026-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210797-001	NCE	2024-10-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210797-001	ODE-270	2026-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210797-001	NCE	2024-10-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210797-001	ODE-270	2026-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210797-001	NCE	2024-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210797-001	NCE	2024-10-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210797-001	ODE-270	2026-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210797-001	NCE	2024-10-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210797-001	ODE-270	2026-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210797-001	NCE	2024-10-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210797-001	ODE-270	2026-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210797-001	NCE	2024-10-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210797-001	ODE-270	2026-10-08	`5aa47cf7b7d7…`

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
SCENESSE	AFAMELANOTIDE	CLINUVEL INC.	94f53286-11dd-7fbb-e053-2a95a90a7c48	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210797 application number: NDA210797 ndc (product): 73372-0116

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73372-0116	SCENESSE	afamelanotide	CLINUVEL INC.	NDA	Current
73372-0116	SCENESSE	afamelanotide	CLINUVEL INC.	NDA	Current
73372-0116	SCENESSE	afamelanotide	CLINUVEL INC.	NDA	Current
73372-0116	SCENESSE	afamelanotide	CLINUVEL INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79384	SUPPL	2024-08-13
79378	SUPPL	2024-08-13
63911	ORIG	2020-07-15
60510	ORIG	2019-10-10
60508	ORIG	2019-10-10