Prescription medicine

Enlicitide Brand names: Lipfendra

Enlicitide (Lipfendra) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the enlicitide FDA label on DailyMed (effective July 15, 2026, Merck Sharp & Dohme LLC); the NDA 220848 record on Drugs@FDA; every enlicitide label on DailyMed.

Highlights of the record

FDA label of July 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Forms and strengths

20 mg

Film-coated tablet.

On the market

Earliest approval on file: July 15, 2026 Lipfendra, Msd; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: February 4, 2040 Lipfendra tablets; 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

What is enlicitide used for?

From the label: indications and usage
LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). 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 enlicitide's FDA labels, with every medicine labeled for each:

High cholesterol

Source: FDA drug label (LIPFENDRA), NDA220848 (Msd), as published by Merck Sharp & Dohme LLC, effective July 15, 2026 (SPL set 100ec543-fbd0-44fc-b740-db9cdff39145), via openFDA; the full label on DailyMed

Is there a generic for enlicitide (Lipfendra)?

No generic enlicitide is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Lipfendra tablets: the compound patent runs to February 4, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2026 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 else is labeled for the same conditions as enlicitide?

15 other medicines are given the same way (oral) and in the same FDA class as enlicitide 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	High cholesterol	61 labelers	$0.0228 per tablet 10 mg tablet	No current entry
Fenofibrate	High cholesterol	54 labelers	$0.103 per tablet 160 mg tablet	No current entry
Lovastatin	High cholesterol	19 labelers	$0.0436 per tablet 20 mg tablet	No current entry
Gemfibrozil	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
Ezetimibe	High cholesterol	23 labelers	$0.0667 per tablet 10 mg tablet	No current entry
Cholestyramine	High cholesterol	15 labelers	$0.834 per packet Cholestyramine packet	No current entry
Colesevelam	High cholesterol	15 labelers	$0.262 per tablet 625 mg tablet	No current entry

Every medicine labeled for the same conditions as enlicitide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to enlicitide: 15 medicines for the same use
Check an interaction: what two or more labels say about each other