Prescription medicine
Bempedoic acid and ezetimibe Brand names: Nexlizet
Bempedoic acid and ezetimibe (Nexlizet) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $13.80 per Nexlizet 180-10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the bempedoic acid and ezetimibe FDA label on DailyMed (effective June 25, 2026, Esperion Therapeutics, Inc.); the NDA 211617 record on Drugs@FDA; every bempedoic acid and ezetimibe label on DailyMed.
Highlights of the record
FDA label of June 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Forms and strengths
- 180 mg / 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 26, 2020 Nexlizet, Esperion Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 19, 2040 Nexlizet tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $13.80 per tablet Nexlizet 180-10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2023 0 Class I among all firms' recalls; latest March 27, 2024
- FAERS reports
- 687 through July 30, 2026
What is bempedoic acid and ezetimibe used for?
From the label: indications and usageNEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Bempedoic acid, a component of NEXLIZET, is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). […]
Conditions named in the indications of bempedoic acid and ezetimibe's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Adenosine Triphosphate-Citrate Lyase Inhibitor and Dietary Cholesterol Absorption Inhibitor.
Source: FDA drug label (Nexlizet), Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 3fa2108c-0300-47b8-9d34-f762af7c93c6), via openFDA; the full label on DailyMed
Is there a generic for bempedoic acid and ezetimibe (Nexlizet)?
No generic bempedoic acid and ezetimibe is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Nexlizet tablets: the compound patent runs to June 19, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bempedoic acid and ezetimibe (Nexlizet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.80 per Nexlizet 180-10 mg tablet, up 3% from $13.44 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nexlizet 180-10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nexlizet 180-10 mg tablet | Brand | $13.80 per tablet | $413.89 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bempedoic acid and ezetimibe been recalled?
The FDA's Enforcement Report lists 2 recalls naming bempedoic acid and ezetimibe since 2023: 0 Class I (the most serious), 0 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 27, 2024 | Class III | Esperion | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. |
| August 16, 2023 | Class III | Esperion | Failed dissolution specifications: below specification results at stability 12-month |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bempedoic acid and ezetimibe label say about other medicines?
The bempedoic acid and ezetimibe label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Clinical Impact: Concomitant use of NEXLIZET and cholestyramine decreases ezetimibe concentration. This may result in a reduction of efficacy. Intervention: Administer NEXLIZET either at least 2 hours before or at least 4 hours after bile acid sequestrants [see Dosage and Administration (2.2) ]. … |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of NEXLIZET and cyclosporine increases ezetimibe and cyclosporine concentrations. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency. Intervention: Monitor cyclosporine concentrations in patients receiving NEXLIZET and cyclosporine. In patients treated with cyclosporine, weigh the potential effects of the increased exposure to ezetimibe from … |
| Fenofibrate | drug interactions | Clinical Impact: Both fenofibrate and ezetimibe (a component of NEXLIZET) may increase cholesterol excretion into the bile, leading to cholelithiasis. Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended. Intervention: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. |
| Pravastatin | drug interactions | Pravastatin Clinical Impact: Concomitant use of NEXLIZET with pravastatin causes an increase in pravastatin concentration and may increase the risk of pravastatin-related myopathy. Intervention: Avoid concomitant use of NEXLIZET with pravastatin greater than 40 mg. |
| Simvastatin | drug interactions | Simvastatin Clinical Impact: Concomitant use of NEXLIZET with simvastatin causes an increase in simvastatin concentration and may increase the risk of simvastatin-related myopathy. Intervention: Avoid concomitant use of NEXLIZET with simvastatin greater than 20 mg. |
Other labels that name bempedoic acid and ezetimibe
Source: FDA drug label (Nexlizet), Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 3fa2108c-0300-47b8-9d34-f762af7c93c6), via openFDA; the full label on DailyMed
What do FAERS reports show for bempedoic acid and ezetimibe?
The FDA Adverse Event Reporting System holds 687 reports that list bempedoic acid and ezetimibe among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 61 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bempedoic acid and ezetimibe?
16 other medicines are given the same way (oral) and in the same FDA class as bempedoic acid and ezetimibe or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | Heart attack and coronary artery disease, High cholesterol | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Gemfibrozil | Heart attack and coronary artery disease, High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
Every medicine labeled for the same conditions as bempedoic acid and ezetimibe
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bempedoic acid and ezetimibe
- 16 medicines for the same use
- Other adenosine triphosphate-citrate lyase inhibitors
- the pharmacologic class, with prices and generics
- Bempedoic acid and ezetimibe side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other