Sol-Gel Technologies collaboration partner first-to-file ANDA generic to Zoryve

Sol-Gel Technologies (SLGL) announced that Padagis Israel Pharmaceuticals, Sol-Gel’s collaboration partner, submitted a first-to-file Abbreviated New Drug Application, ANDA, to the U.S. Food and Drug Administration for Roflumilast Cream, 0.3%, a drug product generic to Zoryve Cream, indicated for the treatment of plaque psoriasis in patients six years of age and older. On March 26, 2024, Arcutis Biotherapeutics, Inc. (ARQT) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA. “According to recent leading analysts’ reports, Zoryve Cream is estimated to generate net revenue exceeding $500 million by the end of 2030. Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis. Though Sol-Gel exited the majority of the partnership in the generic divestment deal announced on November 4, 2021, the Roflumilast Cream, 0.3% project was maintained because of the potential value to both companies,” stated Mr. Mori Arkin, Executive Chairman of the Board of Sol-Gel.