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Verrica Pharmaceuticals Announces that YCANTH™ Receives New Chemical Entity Status and Orange Book Listing from the FDA
NCE status provides a minimum of five years of regulatory exclusivity The Company’s U.S. patents and pending patent applications related to YCANTH™ are
About this update from Verrica Pharmaceuticals Inc.
[{"type":"text","content":"NCE status provides a minimum of five years of regulatory exclusivity The Company’s U.S. patents and pending patent applications related to YCANTH™ are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity. “We could not be more pleased to announce YCANTH™ has been granted NCE Status by the FDA,” said Ted White, Verrica’s President and Chief Executive Officer. “Today’s announcement represents the continued execution of our Company’s comprehensive intellectual property strategy to maximize the patent and regulatory protections surrounding YCANTH™ and further underscores the product’s innovation and intrinsic value in the dermatology market. While NCE status will provide YCANTH™ with a minimum of five years of protection, we anticipate our full patent portfolio to provide protection from generic competition for the next decade and potentially beyond.” Formally described as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is an FDA publication that provides a list of drugs approved as safe and effective and also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data.1 The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled. About Verrica Pharmaceuticals Inc.Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, YCANTH™ (cantharidin), became the first treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102)...