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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 215985


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NDA 215985 describes ZORYVE, which is a drug marketed by Arcutis and is included in two NDAs. It is available from one supplier. There are twenty patents protecting this drug. Additional details are available on the ZORYVE profile page.

The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 215985
Tradename:ZORYVE
Applicant:Arcutis
Ingredient:roflumilast
Patents:16
Pharmacology for NDA: 215985
Mechanism of ActionPhosphodiesterase 4 Inhibitors
Suppliers and Packaging for NDA: 215985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORYVE roflumilast CREAM;TOPICAL 215985 NDA Arcutis Biotherapeutics, Inc. 80610-105 80610-105-60 1 TUBE in 1 CARTON (80610-105-60) / 60 g in 1 TUBE
ZORYVE roflumilast CREAM;TOPICAL 215985 NDA Arcutis Biotherapeutics, Inc. 80610-105 80610-105-96 6 TUBE in 1 CARTON (80610-105-96) / 5 g in 1 TUBE (80610-105-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.3%
Approval Date:Jul 29, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 5, 2026
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:10,940,142Patent Expiration:Jun 7, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:11,129,818Patent Expiration:Aug 25, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PLAQUE PSORIASIS, INCLUDING INTERTRIGINOUS AREAS, IN PATIENTS 12 YEARS OF AGE AND OLDER. (1)

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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