Is Primus Pharmaceuticals, Inc. FDA approved?

Primus Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Primus Pharmaceuticals, Inc. make?

2 products are listed under Primus Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as cream; spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Primus Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 15
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
cream	1
spray	1

Route	NDCs
topical	2

Labeller name on the listing	NDCs
primus pharmaceuticals, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10064875	IMPOYZclobetasol propionate	product	Aug 2030
10179137	SERNIVObetamethasone dipropionate	product	Aug 2030
10588914	IMPOYZclobetasol propionate	product	Aug 2030
11179465	IMPOYZclobetasol propionate	product	Aug 2030
9364485	SERNIVObetamethasone dipropionate	product	Aug 2030
9433630	SERNIVObetamethasone dipropionate	product	Aug 2030
9439911	SERNIVObetamethasone dipropionate	product	Aug 2030
9655907	SERNIVObetamethasone dipropionate	product	Aug 2030
9775851	SERNIVObetamethasone dipropionate	product	Aug 2030
9877974	SERNIVObetamethasone dipropionate	product	Aug 2030
9956231	IMPOYZclobetasol propionate	product	Aug 2030
9855334	IMPOYZclobetasol propionate	product	Mar 2035
11918559	METAXALONEmetaxalone	product	Jul 2039
12485111	METAXALONEmetaxalone	product	May 2043
12661489	SERNIVObetamethasone dipropionate	use	Nov 2045

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Impoyz	clobetasol propionate	cream, topical	68040-713NDA
Sernivo	betamethasone dipropionate	spray, topical	68040-714NDA

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Enquiry

Common questions

Is Primus Pharmaceuticals, Inc. FDA approved?: Primus Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Primus Pharmaceuticals, Inc. make?: 2 products are listed under Primus Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as cream; spray. 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.