ORFADIN 20 MG — DIN 02459736
NITISINONE : 20 MG · SWEDISH ORPHAN BIOVITRUM AB (PUBL) · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is ORFADIN?
ORFADIN 20 MG contains NITISINONE : 20 MG. It is listed in the Health Canada Drug Product Database under DIN 02459736, held by SWEDISH ORPHAN BIOVITRUM AB (PUBL), supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Feb-2017. 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.
How much does Nitisinone cost around the world?
Nitisinone is listed on 6 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; Czechia publishes a max producer price (ex-factory); Italy publishes a prezzo al pubblico (classe A). 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 | 10 | AUD███.██ |
| Italy | prezzo al pubblico (classe A) | 9 | 9 | EUR███.██ |
| Saudi Arabia | public | 8 | 8 | SAR███.██ |
| United Kingdom | hospital | 5 | 5 | GBP███.██ |
| Luxembourg | reimbursement | 5 | 5 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 1 | 2 | CZK███.██ |
39 pack listings across 29 brand entries and 6 price bases, refreshed 08 Sep 2026. Ranges span every Nitisinone 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 Nitisinone 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.
3 holders have a Canadian DIN containing Nitisinone, across 12 DINs, of which 8 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 5 | 5 | ORFADIN | Sourceable in Canada |
| MENDELIKABS INC | 4 | 3 | MDK-NITISINONE | Sourceable in Canada |
| CYCLE PHARMACEUTICALS LTD. | 3 | 0 | NITISINONE TABLETS | No marketed DIN |
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 | 20 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Nitisinone |
|---|---|
| ATC code | A16AX04 |
| AHFS class | 92:92.00 |
| 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) | 02459736 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2459736 |
| Brand name | ORFADIN |
| Generic / active ingredient | NITISINONE : 20 MG |
| Market authorization holder | SWEDISH ORPHAN BIOVITRUM AB (PUBL) |
| Health Canada schedule | Prescription |
| ATC code | A16AX04 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A16AX |
| Current status | MARKETED |
| Status date | 17-Feb-2017 |
| Original market date | 2017-02-17 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
8 of 12 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| MDK-NITISINONE | 2 MG | CAPSULE | MENDELIKABS INC | MARKETED | 02457717 |
| MDK-NITISINONE | 5 MG | CAPSULE | MENDELIKABS INC | MARKETED | 02457725 |
| MDK-NITISINONE | 10 MG | CAPSULE | MENDELIKABS INC | MARKETED | 02457733 |
| ORFADIN | 5 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459701 |
| ORFADIN | 4 MG | SUSPENSION | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02469693 |
| ORFADIN | 10 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459728 |
| ORFADIN | 2 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459698 |
| MDK-NITISINONE | 20 MG | CAPSULE | MENDELIKABS INC | DORMANT | 02470055 |
| NITISINONE TABLETS | 10 MG | TABLET | CYCLE PHARMACEUTICALS LTD. | CANCELLED POST MARKET | 02458632 |
| NITISINONE TABLETS | 5 MG | TABLET | CYCLE PHARMACEUTICALS LTD. | CANCELLED POST MARKET | 02458624 |
2 · Same class — other molecules in ATC A16AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Nitisinone | MDK-NITISINONE · NITISINONE TABLETS · ORFADIN | 12 | 8 | Yes |
| Sapropterin | KUVAN · REDDY-SAPROPTERIN · TEVA-SAPROPTERIN | 7 | 5 | Yes |
| Miglustat | OPFOLDA · SANDOZ MIGLUSTAT · ZAVESCA | 3 | 3 | Yes |
| Trientine | MAR-TRIENTINE · WAYMADE-TRIENTINE | 2 | 2 | Yes |
| Anethole Trithione | SIALOR · SIALOR TAB 25MG · SULFARLEM TAB 12.5MG | 3 | 1 | Yes |
| Migalastat | GALAFOLD | 1 | 1 | Yes |
| Lumasiran | OXLUMO | 1 | 1 | Yes |
| Glycerol Phenylbutyrate | RAVICTI | 1 | 1 | Yes |
| Givosiran | GIVLAARI | 1 | 1 | Yes |
| Sodium Phenylbutyrate | PHEBURANE | 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 A16A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A16AB | Agalsidase Alfa · Agalsidase Beta · Alglucosidase Alfa · Asfotase Alfa · Avalglucosidase Alfa · +12 more | 26 | 22 |
| A16AA | Betaine · Carglumic Acid · Levocarnitine · Mercaptamine · Metreleptin | 11 | 11 |
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.