NITISINONE TABLETS 10 MG — DIN 02458632
NITISINONE : 10 MG · CYCLE PHARMACEUTICALS LTD. · TABLET · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is NITISINONE TABLETS?
NITISINONE TABLETS 10 MG contains NITISINONE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02458632, held by CYCLE PHARMACEUTICALS LTD., supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 31-Oct-2025. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is NITISINONE TABLETS used for?
NITISINONE TABLETS are indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Treatment with NITISINONE TABLETS should be initiated and supervised by a physician experienced in the treatment of HT-1.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
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.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
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 | 10 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Each bottle contains 60 tablets. |
| Storage | null |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
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) | 02458632 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2458632 |
| Brand name | NITISINONE TABLETS |
| Generic / active ingredient | NITISINONE : 10 MG |
| Market authorization holder | CYCLE PHARMACEUTICALS LTD. |
| Health Canada schedule | Prescription |
| ATC code | A16AX04 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A16AX |
| Current status | CANCELLED POST MARKET |
| Status date | 31-Oct-2025 |
| Original market date | 2016-12-19 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 | 2 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459698 |
| ORFADIN | 10 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459728 |
| ORFADIN | 20 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459736 |
| ORFADIN | 4 MG | SUSPENSION | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02469693 |
| ORFADIN | 5 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | 02459701 |
| MDK-NITISINONE | 20 MG | CAPSULE | MENDELIKABS INC | DORMANT | 02470055 |
| 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.
What else is NITISINONE TABLETS called?
The same molecule, Nitisinone, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Orfadin | Latin | Australia, Czechia, Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.