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Biofrontera Inc. Announces FDA Orange Book Listing of U.S. Patent for BF-RhodoLED® XL, Extends Protection of Ameluz®-PDT Through October 2040
WOBURN, Mass., March 14, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of
About this update from Biofrontera Inc.
[{"type":"text","content":"WOBURN, Mass., March 14, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the previously granted U.S. patent No. 11,235,169 (the ’169 patent) for the BF-RhodoLED® XL illumination device is now listed in the U.S. Food and Drug Administration (FDA) publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. BF-RhodoLED® XL is a red-light lamp approved by the FDA for use in photodynamic therapy (PDT) in combination with Ameluz® (Ameluz®-PDT) for the treatment of mild-to-moderate actinic keratosis. Inclusion of the ’169 patent in the Orange Book provides Ameluz®-PDT with protection through October 2040. The listing of a patent in the Orange Book is confirmation by the FDA that such patent protects an approved drug or drug-device combination and constitutes a hurdle for generic manufacturers who wish to launch a generic product. Should Biofrontera become aware of a generic product imitating the Ameluz®-PDT drug-device combination prior to the expiration of the ’169 patent, the filing of a lawsuit would automatically trigger a 30-month stay on the sale of the generic product. \"The Orange Book listing is an endorsement by the FDA that the '169 patent covers our exclusively licensed approved drug-device combination and forestalls any potential generic competition until mid-2040. As previously announced two new patents related to the advanced BF-RhodoLED® XL lamp have recently been granted by the U.S. Patent and Trademark Office. Through our exclusive agreement with Biofrontera Pharma GmbH, our patent strategy is designed to strengthen our competitive advantage by enabling long-lasting protection for Ameluz®-PDT,\" commented Erica Monaco, Chief Executive Officer of Biofrontera Inc. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on PDT and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit www.biofrontera-us.com. Forward-Looking Statements Certain state...