Esperion settles patent dispute with Aurobindo, delaying generic launches until 2040
Key Facts
Esperion announced on November 10, 2026, a settlement with Aurobindo Pharma Limited and one of its affiliates to resolve a patent lawsuit related to applications to market generic versions of NEXLETOL and NEXLIZET in the United States. Under the agreement, Aurobindo will not market a generic version of either drug before April 19, 2040, subject to customary limited exceptions of the kind included in such agreements. Esperion said the lawsuit was filed in response to ANDA applications seeking approval to market the generic versions before the applicable patents expire. The agreement sets a conditional date for the start of marketing and does not end the company's other patent disputes. The company had previously announced a settlement with Renata Limited and one of its affiliates on October 7, 2026.
The case concerns two treatments Esperion markets as part of its current portfolio of once-daily oral non-statin therapies. NEXLETOL contains bempedoic acid, while NEXLIZET combines bempedoic acid and ezetimibe. The U.S. Food and Drug Administration's labeling says NEXLETOL is indicated to reduce the risk of major cardiovascular events in adults at higher risk who are unable to take recommended statin therapy. The label also cites its use to lower low-density lipoprotein cholesterol in patients with hypercholesterolemia. The company said it markets two therapies in this class, each taken once daily.
Product sales put the two drugs in context of the settlement's importance to Esperion's business, although the agreement does not specify an expected financial impact. The company recorded net product sales of 159.6 million dollars in 2025, compared with 115.7 million dollars in 2024. Esperion attributed the increase to prescription growth for NEXLETOL and NEXLIZET. In its annual results published in March 2026, it said U.S. product sales in the fourth quarter of 2025 rose about 38% year over year to 43.7 million dollars. Retail prescription equivalents increased 34% in the same quarter compared with the corresponding period of 2024.
The patent disputes that led to this settlement stem from generic drugmakers' applications for marketing approval before the patents expire. Esperion said in its annual filing that, beginning in May 2024, it filed lawsuits under the Hatch-Waxman Act in the U.S. District Court for the District of New Jersey against ANDA applicants. Following the Aurobindo settlement, the announced lawsuits against MSN Pharmaceuticals and Sandoz remained ongoing, according to the company. When Esperion announced the Renata settlement on October 7, it said the three cases were still pending at that time. This means the November 10 agreement resolves one dispute in the litigation, but does not settle the remaining lawsuits.
According to the FDA's 2026 labeling, the NEXLETOL cardiovascular outcomes trial included 6,992 patients, compared with 6,978 patients who received a placebo, with a median follow-up of 3.4 years. The primary composite endpoint was recorded in 11.7% of the NEXLETOL group, compared with 13.3% of the placebo group. The label presents these results as part of the treatment data, while the settlement is limited to the timing and terms of Aurobindo's generic marketing. The company's statement described Esperion as wholly owned by ARCHIMED. The EL7 data provided did not include daily closing prices or a share-price reaction specific to the announcement.