Press Releases October 7, 2026 08:00 AM

Esperion Reaches Settlement Agreement with Sixth ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) & NEXLIZET® (bempedoic acid & ezetimibe) Prior to April 19, 2040

Esperion Settles Patent Litigation with Sixth ANDA Filer, Blocking Generic Competition Until 2040

By Hana Yamamoto
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Esperion Therapeutics has reached a settlement agreement with Renata Limited preventing the marketing of generic versions of its cholesterol-lowering drugs NEXLETOL and NEXLIZET in the US until April 19, 2040, reinforcing its patent protection. Ongoing litigations with other generic filers continue. Esperion, wholly owned by ARCHIMED, focuses on cardiometabolic therapies and seeks to expand its product pipeline and partnerships globally.

Esperion Reaches Settlement Agreement with Sixth ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) & NEXLIZET® (bempedoic acid & ezetimibe) Prior to April 19, 2040
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Key Points

  • Settlement with Renata Limited delays generic competition for NEXLETOL and NEXLIZET until 2040.
  • Esperion maintains strong US market exclusivity for its non-statin cholesterol therapies, supporting commercial interests.
  • Ongoing patent litigation remains with other generic manufacturers, creating some uncertainty about future generic entries.

ANN ARBOR, Mich., Oct. 07, 2026 (GLOBE NEWSWIRE) -- Esperion, a company wholly-owned by ARCHIMED, today announced that it has entered into a settlement agreement with Renata Limited (along with an affiliate). This agreement resolves the patent litigation brought by Esperion against Renata in response to Renata’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, Renata 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); 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. For more information, visit esperion.com and follow Esperion on LinkedIn and X.

About ARCHIMED
With offices in Europe, North America and Asia, ARCHIMED is a leading investment firm focused exclusively on healthcare industries. Its mix of operational, medical, scientific and financial expertise allows ARCHIMED to serve as both a strategic and financial partner to healthcare businesses. Prioritized areas of focus include Animal & Environmental Health, Biopharma Products, Consumer Health, Diagnostics, Healthcare IT, Life Science Tools & Services, and MedTech. ARCHIMED helps partners internationalize, acquire, innovate and expand their products and services. ARCHIMED manages €9 billion across its various funds. Since inception, ARCHIMED has been a committed Impact investor, both directly and through its EURÊKA Foundation. For more information about ARCHIMED, please visit www.ARCHIMED.group.

Esperion Contact Information:
Media:
Tiffany Aldrich
[email protected]
(616) 443-8438


Risks

  • Pending patent litigation outcome with other generic filers could affect market exclusivity and revenues.
  • Potential reliance on success of current drug portfolio and pipeline development to sustain growth.
  • Changes in regulatory or healthcare reimbursement environments could impact product adoption and company performance.

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