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Biofrontera Receives Patent Approval For Updated Formulation Of Ameluz Nanoemulsion Gel Without Propylene Glycol, Through To December 2043

Benzinga·05/15/2025 16:20:37
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  • Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043
  • Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4
  • Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2
  • The US acne treatment market was valued at $5.7 billion in 2024 and is growing annually5

WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), received confirmation that the updated formulation of the Ameluz® nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz® by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz® against generic competition, Biofrontera today announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris.