Xeris Secures Additional Orange Book Patent Protection for Recorlev Through 2040
Key Insights
Xeris Biopharma received FDA Orange Book listing for a new patent covering Recorlev (levoketoconazole) therapeutic methods that minimize drug-drug interactions with MATE1 (search) substrates, extending protection to March 2040.
The patent strengthens intellectual property protection for the FDA-approved treatment of endogenous Cushing's syndrome (search) in adult patients for whom surgery is not an option or has not been curative.
Recorlev now holds four Orange Book-listed patents, providing enhanced market exclusivity and generic drug monitoring capabilities for this rare endocrine disease therapy.
Xeris Biopharma Holdings (search) announced that the U.S. Patent and Trademark Office has issued patent number 12,377,096 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 (search) substrates, extending protection to March 2040.
Enhanced Intellectual Property Portfolio
With this latest addition, Recorlev now holds four Orange Book-listed patents extending to 2040, strengthening the company's intellectual property position for this rare disease therapy. Orange Book-listed patents cover drugs that the FDA has approved and deemed both safe and effective for the general public's use, and inclusion in the patent list facilitates monitoring for potential generic drug infringement.
"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 (search) and hypercortisolemia (search), a complex and underserved condition."
Therapeutic Profile and Market Position
Recorlev® (levoketoconazole) received FDA approval in December 2021 for the treatment of endogenous Cushing's syndrome (search) in adult patients for whom surgery is not an option or has not been curative. The drug functions as an adrenal steroidogenesis inhibitor and represents a purified enantiomer of ketoconazole. Notably, Recorlev is not classified as a controlled substance by the U.S. Drug Enforcement Administration.
Shannon emphasized the company's commitment to the rare endocrine disease space, stating, "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."
Strategic Implications
The patent specifically addresses drug-drug interaction concerns, a critical consideration in treating patients with Cushing's syndrome (search) who often require multiple medications. By covering methods that minimize interactions with MATE1 (search) substrates, the patent provides both therapeutic and commercial advantages for Xeris's flagship rare disease product.
The Orange Book listing enhances Xeris's ability to monitor the competitive landscape and provides a mechanism to challenge potential generic entrants that could infringe on the company's intellectual property rights through 2040.