ESPR News & Events

Esperion entered into a settlement agreement with Alkem Laboratories. This agreement resolves the patent litigation brought by Esperion against Alkem in response to Alkem's Abbreviated New Drug Applications seeking approval to market generic versions of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Alkem has agreed not to market a generic version of either NEXLETOL or NEXLIZET in the United States prior to April 19, 2040, unless certain limited circumstances customarily included in these types of agreements occur. The pending patent litigation against the remaining defendants is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.

"2025 marked the most successful year in Esperion's history, driven by exceptional execution across our U.S. commercial strategy, expanded global reach and performance, and significant progress across our pipeline - all while delivering meaningful growth in our cardiovascular franchise and strengthening our financial position. These achievements set the stage for something far bigger: Vision 2040. This bold roadmap reflects our commitment to transform Esperion into a multi-product, sustainable, innovation-driven global pharmaceutical company that not only leads in cardiovascular disease prevention but also addresses a broader spectrum of unmet medical needs," said Sheldon Koenig, Chief Executive Officer of Esperion.

Esperion welcomed the inclusion of bempedoic acid as a first-line, evidence-based therapy for LDL-C lowering for patients on maximally tolerated statins in the 2025 American College of Cardiology, ACC, Scientific Statement on Management of Peripheral Artery Disease, PAD, in Adults with Diabetes. "We recognize the significance of the American College of Cardiology's scientific statement highlighting the importance of aggressive LDL-C lowering in patients with diabetes and peripheral artery disease. The inclusion of bempedoic acid reinforces its important role as a proven, evidence-based therapy for reducing both cardiovascular and limb risk in high-risk populations," said Sheldon Koenig, CEO of Esperion. Key ACC Recommendations for LDL-C Lowering in Adults with PAD and Diabetes: Treatment of LDL-C to a target reduction greater than 50% and goal less than 55 mg/dL is recommended, using therapies with proven cardiovascular benefit. High-intensity statins, reinforced by ezetimibe, PCSK9 inhibitors, or bempedoic acid as needed, effectively reduce cardiovascular and limb risk.

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