Is Arcutis Biotherapeutics, Inc. FDA approved?

Arcutis Biotherapeutics, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Arcutis Biotherapeutics, Inc. make?

4 products are listed under Arcutis Biotherapeutics, Inc. in the openFDA NDC Directory, most often as cream; aerosol, foam. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Arcutis Biotherapeutics, Inc.

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

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Registered sites: 0
Active NDC listings: 4
Live patents: 68
Exclusivities: 3
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
cream	3
aerosol, foam	1

Route	NDCs
topical	4

Labeller name on the listing	NDCs
arcutis biotherapeutics, inc.	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10940142	ZORYVEroflumilast	product	Jun 2037
11793796	ZORYVEroflumilast	product	Jun 2037
11819496	ZORYVEroflumilast	use	Jun 2037
11992480	ZORYVEroflumilast	use	Jun 2037
12005051	ZORYVEroflumilast	use	Jun 2037
12005052	ZORYVEroflumilast	product	Jun 2037
12011437	ZORYVEroflumilast	product	Jun 2037
12016848	ZORYVEroflumilast	product	Jun 2037
12042487	ZORYVEroflumilast	product	Jun 2037
12220409	ZORYVEroflumilast	product	Jun 2037
12257242	ZORYVEroflumilast	product	Jun 2037
12310956	ZORYVEroflumilast	use	Jun 2037
12336983	ZORYVEroflumilast	product	Jun 2037
12390453	ZORYVEroflumilast	product	Jun 2037
9884050	ZORYVEroflumilast	product	Jun 2037
9907788	ZORYVEroflumilast	use	Jun 2037
11129818	ZORYVEroflumilast	use	Aug 2037
11707454	ZORYVEroflumilast	use	Dec 2041
12329751	ZORYVEroflumilast	use	Dec 2041
12453721	ZORYVEroflumilast	product	Aug 2042

Product	Exclusivity	Until
ZORYVEROFLUMILAST	I-969 New indication	May 2028
ZORYVEROFLUMILAST	NPP New patient population	Jun 2029
ZORYVEROFLUMILAST	NS New strength	Oct 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ZORYVE	roflumilast	cream, topical	80610-105NDA
ZORYVE	roflumilast	cream, topical	80610-115NDA
ZORYVE	roflumilast	cream, topical	80610-130NDA
ZORYVE	roflumilast	aerosol, foam, topical	80610-430NDA

Compare

Other companies listing roflumilast

AstraZeneca PLC15 sites · 153 NDC
Takeda Pharmaceuticals U.S.A., Inc.7 sites · 226 NDC
Solco healthcare U.S., LLC0 sites · 259 NDC
Jubilant Cadista Pharmaceuticals Inc.0 sites · 48 NDC

Enquiry

Common questions

Is Arcutis Biotherapeutics, Inc. FDA approved?: Arcutis Biotherapeutics, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Arcutis Biotherapeutics, Inc. make?: 4 products are listed under Arcutis Biotherapeutics, Inc. in the openFDA NDC Directory, most often as cream; aerosol, foam. 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.