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Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL (bempedoic acid) Prior to April 19, 2040

Key Takeaway: Esperion has announced a settlement agreement with Accord Healthcare, resolving patent litigation over the generic version of NEXLETOL. The settlement prohibits Accord from marketing a generic version prior to April 19, 2040, except under certain conditions. However, litigation against other defendants remains ongoing, which could impact the timeline for potential generics in the future. Esperion continues to focus on its pipeline and efforts to address cardiovascular diseases with its innovative treatments.

Market Sentiment Analysis

POSITIVE FACTORS

  • Settlement with Accord Healthcare provides clarity on patent protection for NEXLETOL.
  • Agreement extends market exclusivity for NEXLETOL until April 19, 2040.
  • Esperion's commitment to addressing unmet patient needs and advancing biopharmaceuticals remains strong.

Full Press Release Details

ANN ARBOR, Mich., July 08, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed not to market a generic version of NEXLETOL 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 (Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (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.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding pending patent litigation and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:

Frequently Asked Questions

What settlement did Esperion announce with Accord Healthcare?

Esperion settled patent litigation with Accord Healthcare, preventing the sale of a generic NEXLETOL until April 19, 2040.

When can Accord Healthcare market a generic NEXLETOL?

Accord Healthcare cannot market a generic NEXLETOL in the U.S. before April 19, 2040, barring specific circumstances.

Is Esperion involved in other patent litigations?

Yes, Esperion is still engaged in ongoing patent litigation with other defendants regarding NEXLETOL and NEXLIZET.

What type of company is Esperion Therapeutics?

Esperion Therapeutics is a biopharmaceutical company focused on developing medicines for cardiovascular disease.

What is the CLEAR Cardiovascular Outcomes Trial?

The CLEAR trial supports Esperion’s medications for patients with elevated LDL cholesterol, involving nearly 14,000 participants.

Last updated: Jul 8, 2025