Is CLINUVEL INC. FDA approved?

CLINUVEL INC. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does CLINUVEL INC. make?

1 product is listed under CLINUVEL INC. in the openFDA NDC Directory, most often as implant. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CLINUVEL INC.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 1
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8334265	SCENESSEafamelanotide	use	Jan 2033

Product	Exclusivity	Until
SCENESSEAFAMELANOTIDE	ODE-270 Orphan drug	Oct 2026

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
SCENESSE	afamelanotide	implant, subcutaneous	73372-0116NDA

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Other companies listing afamelanotide

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Common questions

Is CLINUVEL INC. FDA approved?: CLINUVEL INC. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does CLINUVEL INC. make?: 1 product is listed under CLINUVEL INC. in the openFDA NDC Directory, most often as implant. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.