Last Updated: November 9, 2026

Details for New Drug Application (NDA): 210797

NDA 210797 describes SCENESSE, which is a drug marketed by Clivunel Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SCENESSE profile page.

The generic ingredient in SCENESSE is afamelanotide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the afamelanotide profile page.

Summary for 210797

Tradename:	SCENESSE
Applicant:	Clivunel Inc
Ingredient:	afamelanotide
Patents:	1

Suppliers and Packaging for NDA: 210797

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797	NDA	CLINUVEL INC.	73372-0116	73372-0116-1	1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;SUBCUTANEOUS			Strength	16MG
Approval Date:	Oct 8, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 8, 2026
Regulatory Exclusivity Use:	INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
Patent:	8,334,265	Patent Expiration:	Jan 20, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)

Expired US Patents for NDA 210797

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clivunel Inc	SCENESSE	afamelanotide	IMPLANT;SUBCUTANEOUS	210797-001	Oct 8, 2019	10,076,555	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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