Prescription medicine
Inclisiran Brand names: Leqvio
Inclisiran (Leqvio) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the inclisiran FDA label on DailyMed (effective August 19, 2026, Novartis Pharmaceuticals Corporation); the NDA 214012 record on Drugs@FDA; every inclisiran label on DailyMed.
Highlights of the record
FDA label of August 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia.
Forms and strengths
- 284 mg/1.5ml
Injection (solution).
On the market
- Earliest approval on file
- December 22, 2021 Leqvio, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 25, 2036 Leqvio injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,973 through July 30, 2026
What is inclisiran used for?
From the label: indications and usageLEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. […]
Conditions named in the indications of inclisiran's FDA labels, with every medicine labeled for each:
Source: FDA drug label (LEQVIO), Novartis Pharmaceuticals Corporation, effective August 19, 2026 (SPL set 6fc0afca-4513-4c35-b594-6544aee29a44), via openFDA; the full label on DailyMed
Is there a generic for inclisiran (Leqvio)?
No generic inclisiran is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Leqvio injection: the compound patent runs to August 18, 2034, and the last listed entry to August 25, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for inclisiran?
The FDA Adverse Event Reporting System holds 7,973 reports that list inclisiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 226 are coded as a death and 793 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 rose sharply in 2023 (2,224, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 inclisiran?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as inclisiran 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. 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 |
|---|---|---|---|---|
| Lerodalcibep | High cholesterol | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Inclisiran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other