Biofrontera Completes FDA NDA And IND Transfers For Ameluz® And RhodoLED® Lamps, Gains Full US Regulatory And IP Control

Biofrontera Inc., a leader in photodynamic therapy development and commercialization, announced the completion of the transfer of FDA approvals for Ameluz® and the RhodoLED® Lamp Series to the Company. This transfer includes both the New Drug Application (NDA) and the Investigational New Drug Application (IND). In addition, Biofrontera has completed the necessary filings to transfer all U.S. and certain international intellectual property related to Ameluz® and the RhodoLED® Lamp Series. 

This includes 11 granted U.S. patents, 10 pending U.S. patent applications, and 19 patent filings or registered designs outside the U.S. The Company has also initiated the registration of the assignment of all associated trademarks. These asset transfers were supported, in part, by an $11.0 million investment recently reported by Biofrontera.

With the NDA and IND transfers effective as of December 17, 2025, Biofrontera now has full control of the Ameluz® regulatory filings in the U.S., allowing the Company to independently manage ongoing and future clinical development activities. Biofrontera also assumes full responsibility for all aspects of manufacturing and marketing Ameluz® and the RhodoLED® lamps in the U.S. The completed patent and trademark transfers further strengthen the Company’s intellectual property portfolio and reinforce its market position in the U.S.

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, stated that this milestone is a significant step in the transformative arrangement the Company began in June 2025. He explained that consolidating control of Ameluz®’s U.S. regulatory filings and its extensive patent portfolio enables Biofrontera to drive operational efficiencies, optimize research and development expenditures, pursue new indications more quickly, and continue enhancing the RhodoLED® lamp platform to meet the evolving needs of clinicians and patients.