Biofrontera Unveils Patented Ameluz® Gel: A Game Changer

Biofrontera Inc. Announces Patented Formula of Ameluz®

Biofrontera Inc. has recently made headlines with its patent approval for a novel formulation of Ameluz®, a topical gel containing aminolevulinic acid HCI, now recognized in the FDA's Orange Book. This approval exemplifies Biofrontera’s innovative approach to developing safer, more effective dermatological treatments.

Key Highlights of the Patent Approval

In an important move for the biopharmaceutical sector, Biofrontera received patent approval for its revised formulation in April. This not only extends the patent protection period until December 2043 but also enhances the product's market position by preventing generic competition for the duration of the patent. The inclusion of Ameluz® in the Orange Book serves as a significant recognition by the FDA, confirming that the revised formula meets the stringent standards of safety and efficacy.

Insights into the FDA Orange Book Inclusion

The Orange Book, officially titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” is a vital resource for pharmacists, healthcare providers, and insurers. This publication lists all FDA-approved prescription products and their associated patent data, underlining their commitment to public health and safety. Being featured in this book indicates the FDA's endorsement of Biofrontera's Ameluz® gel, which signifies both its quality and intellectual property protection.

About the Formulation Changes

The revised formulation of Ameluz® replaces propylene glycol, a common allergen, which can cause reactions in sensitive patients. By focusing on patient safety and comfort, Biofrontera continues to demonstrate its commitment to innovative healthcare solutions. The new formulation not only reduces potential allergic reactions but also retains the therapeutic effectiveness of Ameluz®.

CEO Remarks on the Development

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed pride in the recognition from the FDA, stating that the new formulation enhances patient experience while maintaining effective treatment standards. This patented approach reinforces Biofrontera’s dedication to advancing dermatological therapies.

The Focus on Dermatological Innovation

Biofrontera Inc., based in the United States, specializes in photodynamic therapy (PDT) aimed at treating various dermatological conditions. Ameluz®, combined with the RhodoLED® lamp series, targets actinic keratosis (AK) and pre-cancerous skin lesions. The company is actively pursuing clinical trials to broaden the applications of its products to combat non-melanoma skin cancer and manage severe acne.

Conclusion

The announcement surrounding Biofrontera's patent approval and the formulation changes for Ameluz® reinforces the company's position as a leader in biopharmaceutical innovation. This new patent not only symbolizes an advancement in dermatological treatment but also assures patients and healthcare professionals alike of the commitment to high standards of safety and efficacy.

Frequently Asked Questions

What is the main significance of the patent approval for Ameluz®?

The patent approval signifies extended protection against generic competitors and confirms FDA recognition of the product's safety and efficacy.

Why was propylene glycol removed from the formulation?

Propylene glycol was removed to reduce allergic reactions for patients sensitive to this common excipient, enhancing overall patient safety.

What benefits does the FDA Orange Book provide?

The FDA Orange Book serves as a comprehensive resource for identifying approved prescription drug products, ensuring that healthcare providers have access to reliable information.

How does Ameluz® work in treating skin conditions?

Ameluz® uses photodynamic therapy (PDT) to treat actinic keratosis and other skin lesions, effectively targeting and destroying abnormal skin cells.

What is Biofrontera's focus in biopharmaceuticals?

Biofrontera focuses on developing treatments for dermatological conditions, leveraging innovative therapies like photodynamic therapy to improve patient outcomes.

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