Rozanolixizumab Injection bulk supplier for pharma manufacturers

Rozanolixizumab Injection 140 mg/mL (280 mg/2 mL vial) Suppliers & Bulk Manufacturers

Available Forms: Vial for subcutaneous infusion

Available Strengths: 140 mg/mL (280 mg/2 mL vial)

Pack Sizes: Single vial

Reference Brands: Rystiggo (UCB)

Rozanolixizumab (Rystiggo, UCB) is an FcRn-blocking antibody for generalised myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive. It is given by weekly subcutaneous infusion in six-week cycles. 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:

Rozanolixizumab is a monoclonal antibody that binds the neonatal Fc receptor (FcRn), so IgG antibodies are recycled less and cleared faster. In myasthenia gravis this lowers the autoantibodies that block nerve-to-muscle signals, improving muscle weakness, double vision and difficulty swallowing.

It is approved in the US, EU and Japan for adults with generalised myasthenia gravis who are positive for anti-acetylcholine-receptor (AChR) or anti-muscle-specific-kinase (MuSK) antibodies. It is one of the few treatments with an approval covering MuSK-positive disease. Treatment is given as a weekly subcutaneous infusion with a pump for six weeks, with further cycles based on symptoms. The dose is set by body weight.

Sourcing notes. Rozanolixizumab is patented and there is no biosimilar. Orders should be planned per cycle and per weight band. It needs cold-chain shipping. Efgartigimod is also listed on PharmaTradz.

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

Rozanolixizumab 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 Rozanolixizumab 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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