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ESPR Positive Sentiment Score: 70/100

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

Key Takeaway: Esperion has entered a settlement with Alkem Laboratories to prevent the marketing of generic versions of its drugs NEXLETOL and NEXLIZET until April 19, 2040. This agreement resolves litigation related to Alkem's ANDA filings. However, the company continues to face ongoing patent litigation with other parties, which may affect the exclusivity of its products in the future. Despite these challenges, Esperion maintains a strong market presence and is advancing its pipeline in cardiometabolic therapies.

Market Sentiment Analysis

POSITIVE FACTORS

  • Esperion successfully reached a settlement preventing generic competition until 2040.
  • The company retains exclusivity for NEXLETOL and NEXLIZET, securing its market position.
  • Esperion is well-positioned with a solid commercial infrastructure and global approvals.

CONCERNS & RISKS

  • Ongoing patent litigation against other defendants may still pose risks for exclusivity.
  • There is uncertainty regarding the outcome of the remaining patent litigation.

Full Press Release Details

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. 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 marketing strategy and commercialization and business development plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, 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, business development, 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 agreement did Esperion reach with Alkem Laboratories?

Esperion settled its patent litigation with Alkem, preventing them from marketing generics of NEXLETOL and NEXLIZET in the U.S. before April 19, 2040.

Which companies are still involved in patent litigation?

The ongoing patent litigation includes Aurobindo Pharma, MSN Pharmaceuticals, Renata, and Sandoz.

What therapies does Esperion offer?

Esperion provides two oral, once-daily, non-statin therapies for managing LDL-C levels in patients.

How many countries has Esperion gained approvals in?

Esperion has received approvals in over 40 countries globally.

What potential future treatments is Esperion developing?

Esperion is advancing treatments for Primary Sclerosing Cholangitis and renal diseases.

Last updated: Feb 17, 2026