Esperion settles patent case with Hetero USA over cholesterol drug

ANN ARBOR, Mich. - Esperion Therapeutics Inc. (NASDAQ:ESPR), a biopharmaceutical company with a market capitalization of $168 million and annual revenue of $260 million, has reached a settlement agreement with Hetero USA, Inc. and its affiliates over a patent litigation case. According to InvestingPro data, the company has shown revenue growth of ~13% over the last twelve months, despite operating with significant debt obligations. The dispute stemmed from Hetero USA’s attempt to market a generic version of Esperion’s cholesterol-lowering drug, NEXLETOL, before the expiration of its patents.

Under the terms of the settlement, announced today, Hetero USA will refrain from selling a generic NEXLETOL in the United States until at least April 19, 2040, barring a few exceptional circumstances typically accounted for in such agreements. The settlement effectively ends the litigation between Esperion and Hetero USA.

However, Esperion’s ongoing patent litigation against other defendants, including Accord Healthcare Inc.; Alkem Laboratories Ltd.; Aurobindo Pharma Limited and affiliates; Dr. Reddy’s Laboratories Inc. and affiliates; MSN Pharmaceuticals Inc. and affiliates; Renata Limited; and Sandoz Inc., remains unresolved. There is no certainty regarding the outcome of these cases or if they will allow for generic versions of NEXLETOL and/or NEXLIZET to enter the U.S. market before April 2040.

Esperion specializes in developing non-statin, oral, once-daily medications for individuals at risk of cardiovascular diseases who have elevated low-density lipoprotein cholesterol (LDL-C). The company’s products are backed by a substantial clinical trial involving nearly 14,000 patients. Esperion is also advancing its next-generation program, focusing on ATP citrate lyase inhibitors (ACLYi) for drug development.

The company’s statement also contained forward-looking remarks about its commercial products, ongoing clinical activities, supply chain, and legal proceedings, emphasizing that these statements are subject to risks and uncertainties. InvestingPro analysis reveals several challenges ahead, with analysts projecting a decline in net income this year. For deeper insights into Esperion’s financial health and future prospects, investors can access the comprehensive Pro Research Report, which provides detailed analysis of the company’s performance metrics and growth potential.

This news is based on a press release statement from Esperion Therapeutics.

In other recent news, Esperion Therapeutics reported its Q1 2025 earnings, revealing a wider-than-expected loss per share but significant revenue growth. The company posted an EPS of -$0.21, missing the forecast of -$0.16, while revenue surpassed expectations, reaching $65 million against a forecast of $50.64 million. Despite the revenue beat, the company faced challenges with investor sentiment due to the EPS miss. Additionally, Esperion entered a strategic partnership with HLS Therapeutics, granting HLS exclusive rights to commercialize two cardiovascular treatments, NEXLETOL and NEXLIZET, in Canada. This agreement involves an upfront payment, potential milestones totaling up to $5 million, and tiered royalties on future sales. The company is also focusing on expanding its international partnerships and targeting a new product launch in 2027. Furthermore, Esperion’s products were recently included in the 2025 ACC/AHA multi-society guidelines for managing patients with acute coronary syndrome, potentially aiding in physician adoption. The firm continues to work on enhancing its global reach and expects further prescription volume growth in the coming quarters.

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