Padagis Hit With Immediate Suit After Filing First ANDA For US Zoryve Cream
ANDA Approval Likely Delayed Beyond October 2026; Padagis Eyes 180-Day Exclusivity
Executive Summary
Tipped to bring in sales of $500m or more by 2030, Arcutis Biotherapeutics’ Zoryve 0.3% cream has become the target of an ANDA filed by Padagis, a partner of Sol-Gel Technologies. The originator responded with an immediate suit to shut down any potential generic launch in the near term.