Esperion settles another lawsuit to keep generic versions of popular drug off shelves
Esperion Therapeutics has filed patent infringement lawsuits against eight generic drug makers for filing U.S. Food and Drug Administration (FDA) abbreviated new drug applications (ANDA) to make generic versions of bempedoic acid, which it sells under the brand name Nexletol. The company has now officially settled its lawsuit against Alkem Laboratories to prevent a generic version of the drug from entering the market until the patent expires.
Esperion gained FDA clearance in February 2020 for bempedoic acid, a first-in-class low density lipoprotein cholesterol (LDL-C) lowering medicine. The once-daily oral medication is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.
The drug saw a lot of interest and adoption in cardiology as an alternative to statins, which inspired several generic drug makers to seek ANDA approvals to produce low-cost versions.
In May 2025, Esperion reached its first settlement with generic vendor Micro Labs USA. Additional settlements were reached with Hetero USA in June, Accord Healthcare in July, and Dr. Reddy’s Laboratories in October. These settlements were for patent infringement on Esperion’s U.S patent No. 7,335,799 for bempedoic acid, which is scheduled to expire in December 2030.
Additional patent cases continued over seven other Esperion patents that expire in March 2036 and June 2040. Alkem Laboratories was the first of those cases to be settled. Esperion still has pending lawsuits against Aurobindo Pharma Ltd., MSN Pharmaceuticals Inc., Renata Limited and Sandoz Inc.
These companies filed ANDA requests, but the FDA usually keeps tabs on whether there are patents in place or not.
For example, Ascend Laboratories filed its ANDA letter with the FDA in February 2024. While the October 2025 response letter from the FDA said the company had met the ANDA drug requirements for approval, the FDA could not grant final approval because Esperion's patents covering the drug had not yet expired.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]