Xeris Biopharma Announces Orange Book Listing for Recorlev Patent

Xeris Biopharma Holdings announced the US Patent and Trademark Office has issued a patent for Recorlev, now listed in the FDA's Orange Book. The patent covers methods of treating diseases with levoketoconazole, minimizing drug-drug interactions, and extends to March 2040. Recorlev is approved for treating endogenous Cushing's syndrome in adult patients for whom surgery is not an option or has not been curative.

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) has announced that the U.S. Patent and Trademark Office has issued a patent for Recorlev® (levoketoconazole), which is now listed in the FDA’s Orange Book. The 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. The patent extends to March 2040 [1].

Recorlev® 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. The product is an adrenal steroidogenesis inhibitor and a purified enantiomer of ketoconazole. The inclusion of the patent in the Orange Book makes it easier for drug makers to monitor for new generic drugs that could potentially infringe on their patents [1].

“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,” Shannon added [1].

The Orange 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 [1].

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow them on X, LinkedIn, or Instagram.

References:
[1] https://www.stocktitan.net/news/XERS/xeris-announces-orange-book-listing-of-u-s-patent-for-6qos08fmpdsz.html