Atacicept Injection 150 mg Suppliers & Bulk Manufacturers

Available Forms: Autoinjector (subcutaneous)

Available Strengths: 150 mg

Reference Brands: Trutakna

Atacicept 150 mg subcutaneous autoinjector, a BAFF and APRIL blocking fusion protein for IgA nephropathy, for hospital pharmacies, specialist importers and named-patient programmes using authorised supply.

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Product Description:

Atacicept is a recombinant fusion protein joining part of the TACI receptor to the Fc portion of human IgG. It binds and neutralises two B-cell growth signals, BAFF and APRIL. In IgA nephropathy these signals sustain the B cells and plasma cells that make galactose-deficient IgA1, the abnormal antibody that deposits in the kidney filters. The page covers 150 mg in a prefilled autoinjector for weekly subcutaneous self-injection at home.

It is used to reduce proteinuria in adults with primary IgA nephropathy at risk of progression, alongside blood pressure control and renin-angiotensin blockade. In the US it holds accelerated approval on that basis, with continued approval depending on confirmatory kidney function data. Because it dampens B-cell activity and reduces immunoglobulin levels, prescribers rule out active infection before starting, review vaccination status and watch for infections. A nephrologist starts and supervises treatment.

Sourcing notes. Atacicept is a single-source originator biologic with no biosimilar, so supply runs through authorised channels only. Where it is not registered, it usually moves only as a named-patient or special import under a permit from the destination regulator, so confirm registration status first. Expect refrigerated storage at 2-8 °C, protected from light and never frozen, with an unbroken, logged cold chain; confirm conditions on the label. Ask for the batch release certificate or CoA, proof of the authorised supply chain and serialisation data. It is prescription-only. State the number of autoinjectors, the patient or programme and the import permit reference.

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

Atacicept 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 Atacicept Injection, hold a dossier for it or want to license it, talk to us.

Where atacicept is approved

Checked 3 Oct 2026

Market	Status	Brand · regulator · date
United States	Approved	Trutakna · FDA · Jul 2026 (accelerated)
Generic / biosimilar	None	None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

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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