Xeris Builds a Patent Fortress Around KEVEYIS, Securing It to 2039

CHICAGO, IL – June 11, 2026 – Xeris Biopharma Holdings has executed a textbook maneuver in intellectual property strategy, securing a new patent for its rare disease therapy KEVEYIS® that is expected to shield the product from competition until 2039. The U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for claims covering the “Compositions and Methods of Use” for the drug, a move that erects a formidable barrier around a key, albeit niche, revenue stream for the rapidly growing company.

KEVEYIS is the first FDA-approved treatment for primary periodic paralysis (PPP), a rare and debilitating genetic condition that causes episodes of severe muscle weakness. This new patent provides a long-term runway for a drug that serves a small but highly dependent patient population. Following standard administrative steps, the patent will be listed in the FDA’s “Orange Book,” officially putting potential competitors on notice.

“KEVEYIS is the first FDA-approved therapy for primary periodic paralysis, a rare and debilitating condition, and this Notice of Allowance reflects our long-standing commitment to this highly underserved patient community who depend on it,” said John Shannon, CEO of Xeris, in a statement. “Protecting and strengthening the intellectual property around KEVEYIS ensures we can continue to deliver this important therapy and comprehensive support for the primary periodic paralysis community for years to come.”

A Strategic Moat in a Competitive Market

For investors tracking Xeris (Nasdaq: XERS), this development is less about a single patent and more about the company’s sophisticated ability to protect its assets. The critical context is that KEVEYIS’s orphan drug exclusivity expired in August 2022, and a generic version of the drug was subsequently approved by the FDA. This would typically signal the end of a product's high-margin lifecycle. However, Xeris’s new patent, which focuses on methods of use, is a strategic countermove designed to complicate and deter generic encroachment, effectively creating a new legal moat around the brand.

This IP defense is crucial for a company on a sharp growth trajectory. Xeris has posted impressive results, with revenues growing 41% over the last twelve months to $315 million and a gross profit margin of 86%. After achieving profitability, the company recently raised its full-year 2026 revenue guidance to between $380 million and $390 million, fueled by strong performance across its portfolio. While KEVEYIS is considered a “small orphan-drug franchise” compared to blockbusters, it provides a stable and reliable revenue stream. Securing this income through 2039 reinforces the company’s financial foundation and demonstrates a shrewd understanding of long-term value creation.

Securing a Lifeline for a Rare Disease Community

The business strategy has a profound human impact. Primary periodic paralysis is estimated to affect only 4,000 to 5,000 people in the United States, leaving them vulnerable to sudden attacks of muscle weakness or temporary paralysis that can be life-altering. Before KEVEYIS was approved in 2015, patients had no FDA-vetted treatment options, often relying on off-label use of other medications with inconsistent results.

Clinical data and patient experiences underscore the drug’s importance. KEVEYIS has been shown to reduce the number, severity, and duration of PPP attacks, allowing many to regain control over their lives. The extended patent protection ensures that Xeris can continue investing not only in the supply of the drug but also in its comprehensive patient support infrastructure. Programs like “Patient Access Managers” and the “PPP MentorConnect™” network provide crucial education and community for those navigating the rare disease. The patent news effectively guarantees the stability of this entire ecosystem for more than a decade, offering peace of mind to a community that has long been underserved.

The 'Castle/Moat' Philosophy: Xeris's Broader IP Playbook

This move with KEVEYIS is not an isolated event; it is a clear reflection of Xeris’s overarching “castle and moat” intellectual property philosophy. The company’s strategy involves building layers of patent protection around its products and core technologies to maximize their commercial lifespan. With a global portfolio of 178 patents and another 128 pending applications, Xeris is playing the long game.

This playbook is visible across its portfolio:

• RECORLEV®, for Cushing’s syndrome, has patent protection extending to March 2040 and benefits from orphan drug exclusivity until late 2028. Xeris has already initiated patent infringement lawsuits to defend this asset against generic challengers.

• GVOKE®, a ready-to-use glucagon for severe hypoglycemia, is protected by patents until 2036. While the active ingredient has generic competition, Xeris’s patents on the unique liquid formulation and delivery device have so far prevented a direct generic equivalent from reaching the market.

This aggressive, multi-layered approach to IP is built upon the company’s proprietary XeriSol® and XeriJect® formulation platforms, which enable the development of novel, patentable drug products. The new KEVEYIS patent is another brick in this fortress, showcasing how Xeris leverages legal and scientific innovation to secure its market position. This latest move solidifies the drug's place not just on pharmacy shelves, but as a key case study in Xeris's masterclass on long-term asset protection in the high-stakes biopharmaceutical market.