Esperion Therapeutics announced on May 12, 2025, that it has successfully reached a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited to protect its cholesterol-lowering medication NEXLETOL (bempedoic acid) from generic competition until 2040.
The agreement resolves the patent litigation Esperion initiated against Micro Labs following the company's submission of an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL. Under the terms of the settlement, Micro Labs has agreed not to market a generic version of NEXLETOL in the United States prior to April 19, 2040, unless certain limited circumstances typically included in such agreements occur.
"This settlement represents an important step in protecting our intellectual property and ensuring continued patient access to NEXLETOL," said a representative from Esperion, though the company did not provide specific quotes in its announcement.
Patent Litigation Landscape
While this settlement marks a win for Esperion, the company continues to face patent challenges from multiple fronts. The pending patent litigation against eight remaining defendants is ongoing, including Accord Healthcare Inc., Alkem Laboratories Ltd., Aurobindo Pharma Limited, Dr. Reddy's Laboratories Inc., Hetero USA Inc., MSN Pharmaceuticals Inc., Renata Limited, and Sandoz Inc.
Esperion cautioned investors that there can be no assurance whether the ongoing patent litigation will prevent these companies from marketing generic versions of NEXLETOL and/or NEXLIZET prior to the April 19, 2040 patent expiration date.
NEXLETOL's Clinical Significance
NEXLETOL represents an important advancement in cardiovascular disease management as one of the only FDA-approved oral, once-daily, non-statin medicines for patients struggling with elevated low-density lipoprotein cholesterol (LDL-C). The medication is supported by data from the CLEAR Cardiovascular Outcomes Trial, which included nearly 14,000 patients.
Bempedoic acid works by inhibiting ATP citrate lyase, an enzyme involved in cholesterol synthesis in the liver, offering an alternative mechanism of action compared to statins. This provides an important treatment option for the estimated 10-30% of patients who experience statin intolerance or insufficient LDL-C reduction with existing therapies.
Company Growth Strategy
Esperion continues to evolve its business strategy beyond its current commercial products. The company is advancing its next-generation program focused on developing ATP citrate lyase inhibitors (ACLYi) with potentially improved potency and specificity through allosteric mechanisms.
The biopharmaceutical company has emphasized its commitment to expanding globally through commercial execution, international partnerships, and advancement of its pre-clinical pipeline. These efforts align with Esperion's goal of addressing unmet needs in cardiovascular disease management.
Market Implications
Patent settlements like this one are crucial for pharmaceutical companies to protect revenue streams and continue investing in research and development. NEXLETOL, approved by the FDA in February 2020, represents a significant portion of Esperion's commercial portfolio alongside its combination product NEXLIZET (bempedoic acid and ezetimibe).
Industry analysts note that securing patent protection until 2040 provides Esperion with a substantial runway to maximize the commercial potential of NEXLETOL before facing generic competition. This settlement may also strengthen Esperion's position in negotiations with the remaining ANDA filers.
The outcome of the ongoing litigation against other generic manufacturers will be closely watched by investors and industry observers, as it will significantly impact Esperion's long-term financial outlook and ability to fund future drug development efforts.
