Ann Arbor, Michigan — October 3, 2025 — Leads & Copy — Esperion (NASDAQ: ESPR) announced today it has settled a patent litigation with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd., preventing Dr. Reddy’s from marketing a generic version of NEXLETOL or NEXLIZET in the U.S. before April 19, 2040, unless certain conditions occur.
The agreement resolves the litigation initiated by Esperion in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents.
Esperion previously settled with Micro Labs USA, Inc. and its affiliate; Hetero USA Inc. and its affiliates; and Accord Healthcare Inc. regarding their generic versions of NEXLETOL. Bempedoic acid is claimed in Esperion’s U.S Patent No. 7,335,799, which is scheduled to expire in December 2030. With this latest settlement with Dr. Reddy’s Laboratories, there are no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation. Certain of Esperion’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040.
The patent litigation against Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited (along with an affiliate); and Sandoz Inc. is ongoing. There is no assurance that such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET to be marketed in the U.S. prior to April 19, 2040.
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.
Esperion Contact Information:
Investors: Alina Venezia, investorrelations@esperion.com, (734) 887-3903
Media: Tiffany Aldrich, corporateteam@esperion.com, (616) 443-8438
Source: Esperion Therapeutics, Inc.
