Is Orphalan SA FDA approved?

Orphalan SA 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 Orphalan SA make?

1 product is listed under Orphalan SA in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Orphalan SA

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 5
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10988436	CUVRIORtrientine tetrahydrochloride	substance	May 2039
11072577	CUVRIORtrientine tetrahydrochloride	use	May 2039
12358861	CUVRIORtrientine tetrahydrochloride	substance, product	May 2039
12358862	CUVRIORtrientine tetrahydrochloride	substance, product	May 2039
12662445	CUVRIORtrientine tetrahydrochloride	substance, product	May 2039

Product	Exclusivity	Until
CUVRIORTRIENTINE TETRAHYDROCHLORIDE	ODE-401 Orphan drug	Apr 2029

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CUVRIOR	TRIENTINE TETRAHYDROCHLORIDE	tablet, film coated, oral	81802-001NDA

Enquiry

Common questions

Is Orphalan SA FDA approved?: Orphalan SA 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 Orphalan SA make?: 1 product is listed under Orphalan SA in the openFDA NDC Directory, most often as tablet, film coated. 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.