Biofrontera announces inclusion of patent in FDA Orange Book

Biofrontera Inc. (BFRI) announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz nanoemulsion gel in the U.S. Food and Drug Administration’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. “The patent for the revised formulation of Ameluz was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024,” the company stated. “We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book. This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz(R) RhodoLED PDT,” said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc.