Prescription medicine
Bempedoic acid Brand names: Nexletol
Bempedoic acid (Nexletol) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $13.81 per Nexletol 180 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the bempedoic acid FDA label on DailyMed (effective June 25, 2026, Esperion Therapeutics, Inc.); the NDA 211616 record on Drugs@FDA; every bempedoic acid 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 usageNEXLETOL 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).
Forms and strengths
- 180 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 21, 2020 Nexletol, Esperion Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 Nexletol tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $13.81 per tablet Nexletol 180 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,565 through July 30, 2026
What is bempedoic acid used for?
From the label: indications and usageNEXLETOL 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). as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). […]
Conditions named in the indications of bempedoic acid's FDA labels, with every medicine labeled for each:
From other bempedoic acid labelsHigh cholesterol: … diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including …
FDA pharmacologic class: Adenosine Triphosphate-Citrate Lyase Inhibitor.
Source: FDA drug label (Nexletol), Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 88d06d89-a3da-40b4-b273-8f4f7d56c4c9), via openFDA; the full label on DailyMed
Is there a generic for bempedoic acid (Nexletol)?
No generic bempedoic acid is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Nexletol 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
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bempedoic acid (Nexletol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.81 per Nexletol 180 mg tablet, up 3% from $13.42 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.
- Nexletol 180 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nexletol 180 mg tablet | Brand | $13.81 per tablet | $414.31 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the bempedoic acid label say about other medicines?
The bempedoic acid label names 2 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 |
|---|---|---|
| Pravastatin | drug interactions | Pravastatin Clinical Impact: Concomitant use of NEXLETOL with pravastatin causes an increase in pravastatin concentration and may increase the risk of pravastatin-related myopathy. Intervention: Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg. |
| Simvastatin | drug interactions | Simvastatin Clinical Impact: Concomitant use of NEXLETOL with simvastatin causes an increase in simvastatin concentration and may increase the risk of simvastatin-related myopathy. Intervention: Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg. |
Other labels that name bempedoic acid
Source: FDA drug label (Nexletol), Esperion Therapeutics, Inc., effective June 25, 2026 (SPL set 88d06d89-a3da-40b4-b273-8f4f7d56c4c9), via openFDA; the full label on DailyMed
What do FAERS reports show for bempedoic acid?
The FDA Adverse Event Reporting System holds 2,565 reports that list bempedoic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 240 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?
9 other medicines are given the same way (oral) and in the same FDA class as bempedoic acid or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 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 |
| 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 |
| Ezetimibe and simvastatin | Heart attack and coronary artery disease, High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
| Niacin | Heart attack and coronary artery disease, High cholesterol | 13 labelers | $0.193 per tablet 500 mg tablet | No current entry |
Every medicine labeled for the same conditions as bempedoic acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bempedoic acid
- 9 medicines for the same use
- Other adenosine triphosphate-citrate lyase inhibitors
- the pharmacologic class, with prices and generics
- Bempedoic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other