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Xeris Announces Orange Book Listing of U.S. Patent for Recorlev®
Recorlev now holds four Orange Book-listed patents to 2040 CHICAGO--(BUSINESS WIRE)-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nRecorlev now holds four Orange Book-listed patents to 2040\n\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced the U.S Patent and Trademark Office has issued patent number 12,377,096 to the Company for Recorlev® (levoketoconazole) and that this patent is now listed in the publication, “Approved Drug Products with Therapeutics Equivalence Evaluations,” commonly known as the “Orange Book.” This patent, entitled “Methods of Treating Disease with Levoketoconazole,” covers therapeutic uses of levoketoconazole in methods that minimize drug-drug interactions between levoketoconazole and other commonly co-administered drugs known as MATE1 substrates, and extends to March 2040.\n\n\n“We are pleased to expand and further strengthen the intellectual property protection for Recorlev with the grant of our latest patent and its addition to the FDA’s Orange Book,” said John Shannon, Chief Executive Officer of Xeris. “Recorlev represents a meaningful therapeutic advancement for patients with endogenous Cushing’s syndrome and hypercortisolemia, a complex and underserved condition. As we continue to make strategic investments in education, patient support, and market access, we are equally committed to protecting the long-term value of this important asset. Strengthening our IP position reinforces our confidence in Recorlev’s growth potential and our mission to improve the lives of patients with rare endocrine diseases.”\n\n\nOrange Book-listed patents cover drugs that the FDA has approved and deemed both safe and effective for the general public's use. Inclusion in the book's list of patents can make it easier for drug makers to monitor for new generic drugs that could potentially arrive on the U.S. market and infringe on their patents.\n\n\nRecorlev® (levoketoconazole) was approved by the FDA in December 2021 for the treatment of endogenous Cushing’s syndrome in adult patients for whom surgery is not an option or has not been curative. Recorlev is an adrenal steroidogenesis inhibitor and a purified enantiomer of ketoconazole. The product is protected by multiple patents listed in the FDA’s Orange Book. Recorlev is not classified as a contro...