BYLVAY 200 MCG — DIN 02542641
ODEVIXIBAT : 200 MCG · MEDISON PHARMA CANADA INC. · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is BYLVAY?
BYLVAY 200 MCG contains ODEVIXIBAT : 200 MCG. It is listed in the Health Canada Drug Product Database under DIN 02542641, held by MEDISON PHARMA CANADA INC., supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 07-Feb-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is BYLVAY used for?
Treatment of pruritus in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC) and cholestatic pruritus in patients aged 12 months or older with Alagille syndrome.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Odevixibat cost around the world?
Odevixibat is listed on 7 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Bahrain publishes a retail (max); Iceland publishes a max wholesale. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 1 | 24 | AUD███.██ |
| Italy | ex-factory (classe H) | 8 | 8 | EUR███.██ |
| Luxembourg | reimbursement | 8 | 8 | EUR███.██ |
| Romania | max producer price | 3 | 6 | RON███.██ |
| Bahrain | retail (max) | 1 | 4 | BHD███.██ |
| Saudi Arabia | public | 1 | 4 | SAR███.██ |
| Iceland | max wholesale | 1 | 3 | ISK███.██ |
57 pack listings across 23 brand entries and 7 price bases, refreshed 08 Sep 2026. Ranges span every Odevixibat pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Odevixibat in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Odevixibat — 4 DINs, of which 4 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| MEDISON PHARMA CANADA INC. | 4 | 4 | BYLVAY | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 200 MCG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | High-density polyethylene (HDPE) bottle with a tamper evident, child resistant polypropylene closure. Pack size of 30 capsules. |
| Storage | Not explicitly detailed in provided text (standard section 11 mentioned in TOC but text cuts off). Standard practice: Store at room temperature. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Odevixibat |
|---|---|
| ATC code | A05AX05 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02542641 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2542641 |
| Brand name | BYLVAY |
| Generic / active ingredient | ODEVIXIBAT : 200 MCG |
| Market authorization holder | MEDISON PHARMA CANADA INC. |
| Health Canada schedule | Prescription |
| ATC code | A05AX05 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A05AX |
| Current status | MARKETED |
| Status date | 07-Feb-2024 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administer orally once daily in the morning with a meal. PFIC: 40 mcg/kg/day (may increase to 120 mcg/kg/day). ALGS: 120 mcg/kg/day. Capsules may be swallowed whole or sprinkled on soft food/liquid.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to odevixibat or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Diarrhea may lead to dehydration. Liver test abnormalities (ALT, AST, Bilirubin) and fat-soluble vitamin (A, D, E, K) deficiencies may occur; monitoring required. Not for non-functional BSEP protein.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
4 of 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| BYLVAY | 400 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | 02542676 |
| BYLVAY | 600 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | 02542684 |
| BYLVAY | 1200 MCG | CAPSULE | MEDISON PHARMA CANADA INC. | MARKETED | 02542692 |
2 · Same class — other molecules in ATC A05AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Odevixibat | BYLVAY | 4 | 4 | Yes |
| A05ax04 | LIVMARLI | 1 | 1 | Yes |
| Elafibranor | IQIRVO | 1 | 1 | Yes |
| Maraliximab Chloride | LIVMARLI | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC A05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A05AA | Bile Acid And Derivatives · Obeticholic Acid · Ursodeoxycholic Acid | 29 | 10 |
| A05AB | Preparations For Biliary Tract Therapy | 1 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.