You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 7, 2024

Details for New Drug Application (NDA): 215985


✉ Email this page to a colleague

« Back to Dashboard


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 thirteen 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. Fourteen 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:12
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. 80610-115 80610-115-60 1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE
ZORYVE roflumilast CREAM;TOPICAL 215985 NDA Arcutis Biotherapeutics, Inc. 80610-115 80610-115-96 6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05)

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
Regulatory Exclusivity Expiration:Jul 29, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jun 7, 2037Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.