Eplontersen Injection bulk supplier for pharma manufacturers

Eplontersen Injection 45 mg/0.8 mL Suppliers & Bulk Manufacturers

Available Forms: Pre-filled autoinjector (subcutaneous)

Available Strengths: 45 mg/0.8 mL

Pack Sizes: 1 autoinjector

Reference Brands: Wainua (US), Wainzua (EU) (Ionis / AstraZeneca)

Eplontersen (Wainua in the US, Wainzua in Europe; Ionis and AstraZeneca) is a monthly self-injected medicine for polyneuropathy caused by hereditary transthyretin amyloidosis (hATTR). PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

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Product Description:

In transthyretin amyloidosis, the liver protein transthyretin (TTR) misfolds and builds up as amyloid deposits in nerves and the heart. Eplontersen is an antisense oligonucleotide, linked to a sugar (GalNAc) that steers it to liver cells, where it lowers production of TTR protein. Less TTR means less new amyloid and slower nerve damage.

The US FDA approved eplontersen in December 2023 for polyneuropathy of hereditary ATTR in adults, and approvals in the EU and other markets followed. It is given as a 45 mg injection under the skin once a month from an autoinjector that patients can use at home. A large trial in ATTR cardiomyopathy is under way. Patients take vitamin A supplements, because lowering TTR also lowers vitamin A levels.

Sourcing notes. Eplontersen is patented and there is no generic. Requests usually come through named-patient routes for hereditary ATTR families. Tafamidis, patisiran and vutrisiran are also listed on PharmaTradz.

How Eplontersen Injection is supplied today, and licensing ahead of patent expiry

Eplontersen Injection is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Eplontersen Injection, hold a dossier for it or want to license it, talk to us.

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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