Esperion settles with fifth generic drug maker over cholesterol patents

Esperion Therapeutics Inc. (NASDAQ: ESPR) reached a settlement agreement with Alkem Laboratories Ltd. to resolve patent litigation over generic versions of the company's cholesterol medications NEXLETOL and NEXLIZET.

Under the agreement announced February 17, Alkem agreed not to market generic versions of either drug in the United States before April 19, 2040, unless certain limited circumstances occur. The settlement resolves litigation that began after Alkem filed Abbreviated New Drug Applications seeking approval to market generic versions of both medications.

NEXLETOL contains bempedoic acid, while NEXLIZET combines bempedoic acid with ezetimibe. Both are oral, once-daily treatments for patients with elevated low-density lipoprotein cholesterol levels.

Patent litigation remains active against four other companies: Aurobindo Pharma Limited and an affiliate, MSN Pharmaceuticals Inc. and an affiliate, Renata Limited, and Sandoz Inc. Esperion stated there is no assurance the ongoing litigation will prevent generic versions from reaching the U.S. market before April 19, 2040.

This marks the fifth settlement agreement Esperion has reached with companies that filed applications to produce generic versions of its cholesterol medications. The company has approvals for its products in more than 40 countries.

Esperion focuses on developing treatments for cardiometabolic and rare diseases, leveraging expertise in ACLY biology. The company is advancing additional product candidates including treatments for Primary Sclerosing Cholangitis and renal diseases.

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