Prescription medicine
Alirocumab Brand names: Praluent
Alirocumab (Praluent) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $258.01 per mL (Praluent 150 mg/mL pen) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the alirocumab FDA label on DailyMed (effective July 16, 2026, Regeneron Pharmaceuticals, Inc.); the BLA 125559 record on Drugs@FDA; every alirocumab label on DailyMed.
Highlights of the record
FDA label of July 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events.
Forms and strengths
- 75 mg/ml
- 150 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- July 24, 2015 Praluent, Regeneron Pharmaceuticals; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $258.01 per mL Praluent 150 mg/mL pen
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 24,935 through July 30, 2026
What is alirocumab used for?
From the label: indications and usagePRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH). […]
Conditions named in the indications of alirocumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: PCSK9 Inhibitor.
Source: FDA drug label (Praluent), Regeneron Pharmaceuticals, Inc., effective July 16, 2026 (SPL set 7bcfbac2-e8ac-4569-8edc-bcde3b1fd172), via openFDA; the full label on DailyMed
Is there a generic for alirocumab (Praluent)?
No generic alirocumab is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alirocumab (Praluent)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $258.01 per mL (Praluent 150 mg/mL pen), up 3% from $250.59 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.
- Praluent 75 mg/mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Praluent 150 mg/mL pen | Brand | $258.01 per mL | n/a | +3% |
| Praluent 75 mg/mL pen | Brand | $257.73 per mL | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for alirocumab?
The FDA Adverse Event Reporting System holds 24,935 reports that list alirocumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 506 are coded as a death and 2,620 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 alirocumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as alirocumab or labeled mainly for the same use (angina), the same class first. Angina lists all 21 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Evolocumab | Angina, Heart attack and coronary artery disease, High cholesterol | none listed | $281.96 per mL 140 mg/mL sureclick | No current entry |
| Enoxaparin | Angina, Heart attack and coronary artery disease | 14 labelers | $6.45 per mL 100 mg/mL syringe | No current entry |
| Dalteparin | Angina, Heart attack and coronary artery disease | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as alirocumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does alirocumab compare with medicines for the same use?
1 side-by-side page set alirocumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to alirocumab
- 3 medicines for the same use
- Other pcsk9 inhibitors
- the pharmacologic class, with prices and generics
- Alirocumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other