Biofrontera's Propylene Glycol-Free Ameluz Formulation Receives FDA Orange Book Listing Following April 2025 Patent Approval, Extending Protection Through 2043

Author: Benzinga Newsdesk | June 03, 2025 02:34pm

• Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043.
• The Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all approved prescription drug products, along with patent and exclusivity information.
• Inclusion signifies FDA recognition of the revised formulation's approved status and its intellectual property protection.
  
   

WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book).

The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043.

The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. 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.

Posted In: BFRI