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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

 
• By Dean Rudge

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.

Business Concept As A Full-Energy Businessman Running On Track To Get Through Red Ribbon As Finish Line. It Means Performing The Best Effort To Succeed The Goal And Overcome Difficulty Ahead.
• Source: Shutterstock

Padagis may have to defend itself against alleged patent infringement in the US after filing the first abbreviated new drug application for a generic version of Arcutis Biotherapeutics’ Zoryve (roflumilast) 0.3% cream – a rapidly growing treatment for plaque psoriasis that has been tipped to achieve peak sales exceeding $500m per year by 2030.

The Israeli firm has been sued by Arcturis in a US District Court for the District of New Jersey, with the originator alleging infringement of six

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