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Enlicitide Tablets 20 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 20 mg

Reference Brands: Lipfendra (Merck & Co / MSD)

Category: Heart Disorder

Enlicitide (Lipfendra, Merck/MSD) is the first PCSK9 inhibitor taken as a tablet, used to lower LDL cholesterol. The US FDA approved it in July 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.

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Product Description:

Enlicitide decanoate blocks PCSK9, a protein that makes the liver destroy its own LDL receptors. With PCSK9 blocked, the liver keeps more receptors and clears more LDL ("bad") cholesterol from the blood. Until now this mechanism was only available as injections, either antibodies (evolocumab, alirocumab) or the siRNA inclisiran. Enlicitide is a macrocyclic peptide designed to be absorbed from the gut, so it is taken as a 20 mg tablet once a day.

The US FDA approved enlicitide as Lipfendra in July 2026 to lower LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, usually on top of a statin. It gives people who need more LDL lowering an oral option instead of regular injections.

Sourcing and licensing notes. Enlicitide is patented and made only by Merck & Co (MSD outside the US and Canada); there is no generic. We confirm registration status for each destination before quoting, handle enquiries for authorised supply of Lipfendra where it can lawfully be imported, and we connect developers and licensees interested in the oral PCSK9 class ahead of patent expiry.

How Enlicitide Tablets is supplied today, and licensing ahead of patent expiry

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions

Lowering LDL cholesterol in adults with high cholesterol, including inherited (heterozygous familial) hypercholesterolaemia, usually together with a statin.

Lipfendra, from Merck & Co (MSD). The US FDA approved it in July 2026.

No. It is a 20 mg tablet taken once a day, the first PCSK9 inhibitor that is not injected.

No. It is patented and only Merck makes it. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.

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