Esperion Reaches Settlement Agreement with Fifth ANDA Filer Not to Market Generic Version of NEXLETOL (bempedoic acid) & NEXLIZET (bempedoic acid & ezetimibe) Prior to April 19, 2040
ANN ARBOR, Mich., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem). This agreement resolves the patent litigation brought by Esperion against Alkem in response to Alkem’s Abbreviated New Drug Applications (ANDAs) 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 (Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.) 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.
Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.
With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases.
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