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Odevixibat bulk supplier for pharma manufacturers

Odevixibat 200mcg, 600mcg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 200mcg, 600mcg

Reference Brands: Bylvay (USA/EU)

Category: Gastrointestinal Drugs

Odevixibat is a selective ileal bile acid transporter (IBAT) inhibitor that reduces bile acid reabsorption in the intestine. It is primarily used to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged 3 months and older. By lowering bile acid levels, it helps reduce itching (pruritus) and improves liver function markers.

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Product Description:

Odevixibat is a reversible inhibitor of the ileal bile acid transporter, the protein in the terminal ileum that reabsorbs around ninety-five percent of bile acids for return to the liver. Blocking it interrupts that recycling, so more bile acid is lost in the stool and less reaches the liver and blood. In cholestatic liver diseases of childhood, where bile acids accumulate and cause intense, disabling itch, lower serum bile acids bring relief.

It is used for pruritus in progressive familial intrahepatic cholestasis and, in the US, in Alagille syndrome. It is taken once daily in the morning; capsules can be opened and the pellets sprinkled on soft food for young children. Diarrhoea and abdominal pain are common because more bile acid reaches the colon. Fat-soluble vitamin deficiency — vitamins A, D, E and K — can develop, so levels and clotting are monitored. Liver tests are checked, and it is not suitable in some PFIC subtypes where the transporter defect makes it ineffective.

Sourcing notes. Originator orphan product, on patent, no generic. Very high cost and rare-disease use mean supply is through authorised distribution or named-patient access. A competing IBAT inhibitor is also approved, and genetic confirmation of subtype is normally required for reimbursement.

How Odevixibat 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

Bylvay (Odevixibat) is developed and sold by Ipsen. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.

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