small molecule

ZORYVE

ROFLUMILAST

Loss of exclusivityAugust 2037latest FDA-listed patent expiry
CompanyArcutis Biotherapeutics, Inc.See this company's full patent-cliff portfolio

Drug detail

Brand nameZORYVE
Active ingredientROFLUMILAST
Strength0.05%
Dosage formCREAM
RouteTOPICAL
ModalitySmall molecule
FDA approvalOctober 2025
Marketing statusRX

Listed patents

PatentExpiresType
11129818August 2037use U-4301
11992480June 2037use U-4301
11819496June 2037use U-4301
12005051June 2037use U-4301
9907788June 2037use U-4301
12257242June 2037product
12011437June 2037product
12005052June 2037product
12042487June 2037product
9884050June 2037product
10940142June 2037product
12220409June 2037product
11793796June 2037product
12336983June 2037product
12310956June 2037use U-4301
12016848June 2037product

Regulatory exclusivity

CodeExpires
NSOctober 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

ZORYVE patent cliff — loss of exclusivity August 2037 | CliffBio