Generic Nexletol and Nexlizet: a seventh drugmaker agrees to wait until 2040
Aurobindo will not sell generic Nexletol or Nexlizet in the US before April 19, 2040, the seventh generic maker to settle with Esperion. Two remain in court.
Generic Nexletol and Nexlizet will not come from Aurobindo Pharma before April 19, 2040, under a patent settlement Esperion announced on November 10, 2026. Aurobindo is the seventh generic applicant to accept that date for the two non-statin cholesterol pills, leaving MSN Pharmaceuticals and Sandoz still in court.
Key points
- Aurobindo Pharma and an affiliate agreed not to market a generic version of NEXLETOL (bempedoic acid) or NEXLIZET (bempedoic acid and ezetimibe) in the United States before April 19, 2040, outside limited circumstances customary in such deals.
- The agreement ends the patent case Esperion brought over Aurobindo's abbreviated new drug applications for both medicines.
- Esperion calls Aurobindo the seventh generic filer to settle; its patent suits against MSN Pharmaceuticals and Sandoz continue.
- Esperion, wholly owned by the healthcare investor ARCHIMED, sells both drugs as oral, once-daily therapies for lowering LDL cholesterol.
Who takes Nexletol, and what has it been shown to do?
Nexletol lowers LDL cholesterol, and its largest trial was run in people who cannot take statins. A meta-analysis of 176 studies and more than 4.1 million patients in the European Heart Journal put the overall prevalence of statin intolerance at 9.1%, with higher rates among women, older patients, and people with obesity or diabetes.
For that group, the CLEAR Outcomes trial, published in the New England Journal of Medicine, randomized 13,970 statin-intolerant patients to bempedoic acid or placebo. Over a median of 40.6 months, 11.7% of the bempedoic acid group had a major cardiovascular event against 13.3% on placebo, a hazard ratio of 0.87.
Esperion's 2025 annual report says the FDA first approved both drugs in February 2020 and added a cardiovascular risk reduction indication in March 2024.
How did seven generic makers come to accept a 2040 date?
Each one challenged Esperion's patents and then settled. According to the company's annual report, notices from nine drugmakers began arriving in March 2024, each saying it had filed an abbreviated new drug application with a Paragraph IV certification, the route under the Hatch-Waxman Act for arguing that a brand's patents are invalid or not infringed.
The same report lists earlier settlements with Micro Labs, Hetero USA, Accord Healthcare, Dr. Reddy's Laboratories and Alkem Laboratories, reached between May 2025 and February 2026, each carrying the April 19, 2040 date. Renata Limited became the sixth in October 2026, agreeing to the same date for both drugs, according to Esperion's announcement of that settlement. Aurobindo is the seventh. The annual report also says the patents still in dispute expire in March 2036 or June 2040.
What is left in the generic Nexletol patent fight?
Two defendants. Esperion says its litigation against MSN Pharmaceuticals (with an affiliate) and Sandoz is ongoing, and that it cannot be assured whether those cases will allow either drug to reach the U.S. market as a generic before April 19, 2040. In its annual report, Esperion said a trial against the remaining filers was expected to begin no earlier than January 2027, with no date set.
What does it mean for clinicians and pharmacy teams?
Our analysis: for formulary and benefit planning, bempedoic acid should be treated as a branded product for the long term. Seven of the applicants that sought to copy it have now agreed to stay out of the U.S. market until 2040, and the outcome for the remaining two rests with the courts. That gives pharmacy and benefit teams a firmer horizon for budgeting a non-statin option for patients who stopped statins. For planning around branded medicines, see our roundup on how providers talk with patients about cost and our guide to strategies for healthcare cost reduction.
Frequently asked questions
What is the difference between Nexletol and Nexlizet?
NEXLETOL is bempedoic acid on its own. NEXLIZET combines bempedoic acid with ezetimibe in one tablet. Both are taken by mouth once a day to lower LDL cholesterol.
Who owns Esperion Therapeutics?
Esperion is wholly owned by ARCHIMED, an investment firm that focuses only on healthcare and says it manages €9 billion across its funds.
Does the Aurobindo settlement cover both drugs?
Yes. Aurobindo had filed for generic versions of both NEXLETOL and NEXLIZET, and the agreement keeps it out of the U.S. market for each until April 19, 2040.
Could a generic version arrive in the U.S. before 2040?
That now rests on the cases against MSN Pharmaceuticals and Sandoz. Esperion says there can be no assurance whether that litigation will allow a generic before April 19, 2040.
In how many countries does Esperion hold approvals?
Esperion says it holds approvals in more than 40 countries, alongside its U.S. commercial operation.
Sources
- Esperion settlement announcement: press release from Esperion via GlobeNewswire, 10 November 2026.
- Esperion Therapeutics Form 10-K, fiscal year 2025: the company's annual report filed with the SEC, covering the ANDA litigation, earlier settlements and approvals.
- Esperion settlement with Renata: press release from Esperion via GlobeNewswire, 7 October 2026.
- Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients: the CLEAR Outcomes trial, New England Journal of Medicine, 2023.
- Prevalence of statin intolerance: a meta-analysis: Bytyçi and colleagues, European Heart Journal, 2022.
- Esperion Therapeutics: the company's website.