Is Idorsia Pharmaceuticals Ltd FDA approved?

Idorsia Pharmaceuticals Ltd holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Idorsia Pharmaceuticals Ltd make?

3 products are listed under Idorsia Pharmaceuticals Ltd 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.

Idorsia Pharmaceuticals Ltd

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

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Registered sites: 0
Active NDC listings: 3
Live patents: 12
Exclusivities: 2
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
tablet, film coated	3

Route	NDCs
oral	3

Labeller name on the listing	NDCs
idorsia pharmaceuticals ltd	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8324232	TRYVIOaprocitentan	substance, product	Sept 2029
9732075	QUVIVIQdaridorexant hydrochloride	substance, product	Jun 2033
10023560	QUVIVIQdaridorexant hydrochloride	use	Dec 2034
9790208	QUVIVIQdaridorexant hydrochloride	substance, product	Dec 2034
11174247	TRYVIOaprocitentan	use	Nov 2037
10919881	TRYVIOaprocitentan	substance, product	Feb 2038
12297189	TRYVIOaprocitentan	product	Feb 2038
11787782	TRYVIOaprocitentan	use	Mar 2038
11680058	TRYVIOaprocitentan	use	Jul 2038

Product	Exclusivity	Until
QUVIVIQDARIDOREXANT HYDROCHLORIDE	M-200 Miscellaneous	Sept 2027
TRYVIOAPROCITENTAN	NCE New chemical entity	Mar 2029

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
QUVIVIQ	Daridorexant	tablet, film coated, oral	80491-7825NDA
QUVIVIQ	Daridorexant	tablet, film coated, oral	80491-7850NDA
TRYVIO	Aprocitentan	tablet, film coated, oral	80491-8012NDA

Enquiry

Common questions

Is Idorsia Pharmaceuticals Ltd FDA approved?: Idorsia Pharmaceuticals Ltd holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Idorsia Pharmaceuticals Ltd make?: 3 products are listed under Idorsia Pharmaceuticals Ltd 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.