Arcutis Biotherapeutics, Padagis agree to stay patent lawsuit

Arcutis Biotherapeutics (ARQT) announced that Padagis Israel Pharmaceuticals, Padagis, and Padagis have requested a stay to the ongoing patent litigation between Padagis and the Company, and the Company has agreed to enter a joint stipulation to stay the case, which was filed in the U.S. District Court for the District of Delaware on April 2. After the Court enters the joint stipulation, all calendared dates and trial for the patent litigation will be vacated. As part of the joint stipulation agreement, Padagis is required to report to Arcutis any U.S. Food and Drug Administration correspondence regarding their Abbreviated New Drug Application for their potential generic alternative to Arcutis’ patented product, ZORYVE cream 0.3% for plaque psoriasis. In addition, the parties agreed to extend the 30-month Hatch-Waxman stay of regulatory approval by one day for every day the litigation is stayed as of March 24, 2025, such that in the event the litigation resumes in the future, Arcutis will still benefit from the entirety of the stay afforded to it under the Hatch-Waxman Act. Patent protection for ZORYVE cream 0.3% extends until at least 2037. ZORYVE cream 0.3% is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.