LYSODREN 500 MG — DIN 00463221
MITOTANE : 500 MG · ESTEVE PHARMACEUTICALS S.A. · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is LYSODREN?
LYSODREN 500 MG contains MITOTANE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 00463221, held by ESTEVE PHARMACEUTICALS S.A., supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Jun-2025. 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 Mitotane cost around the world?
Mitotane is listed on 4 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. Austria publishes a KVP (Kassenverkaufspreis); Czechia publishes a max producer price (ex-factory); 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 |
|---|---|---|---|---|
| Romania | max producer price | 1 | 2 | RON███.██ |
| Austria | KVP (Kassenverkaufspreis) | 1 | 1 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 1 | 1 | CZK███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
5 pack listings across 4 brand entries and 4 price bases, refreshed 03 Sep 2026. Ranges span every Mitotane 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.
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 | 500 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Storage | Room Temperature |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Mitotane |
|---|---|
| ATC code | L01XX23 |
| AHFS class | 10:00.00 |
| 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) | 00463221 |
|---|---|
| DIN (unpadded, as printed on some documents) | 463221 |
| Brand name | LYSODREN |
| Generic / active ingredient | MITOTANE : 500 MG |
| Market authorization holder | ESTEVE PHARMACEUTICALS S.A. |
| Health Canada schedule | Prescription |
| ATC code | L01XX23 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01XX |
| Current status | MARKETED |
| Status date | 26-Jun-2025 |
| Original market date | 1979-12-31 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.
2 · Same class — other molecules in ATC L01XX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Arsenic Trioxide | ARSENIC TRIOXIDE FOR INJECTION · ARSENIC TRIOXIDE SOLUTION FOR INJECTION · TEVA-ARSENIC TRIOXIDE FOR INJECTION · TRISENOX | 10 | 4 | Yes |
| Hydroxycarbamide | APO-HYDROXYUREA · EUGIA-HYDROXYUREA · HYDREA · HYDROXYUREA · +2 more | 6 | 4 | Yes |
| Venetoclax | VENCLEXTA | 4 | 4 | Yes |
| Eribulin | ERIBULIN MESYLATE INJECTION · HALAVEN · NAT-ERIBULIN | 3 | 2 | Yes |
| Sotorasib | LUMAKRAS | 2 | 2 | Yes |
| Anagrelide | AGRYLIN · DOM-ANAGRELIDE · MYLAN-ANAGRELIDE · PHL-ANAGRELIDE · +2 more | 6 | 1 | Yes |
| Asparaginase | ERWINASE · KIDROLASE · RYLAZE | 3 | 1 | Yes |
| Pegaspargase | ONCASPAR | 2 | 1 | Yes |
| Belzutifan | WELIREG | 1 | 1 | Yes |
| Tebentafusp | KIMMTRAK | 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 L01X
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01XG | Bortezomib · Carfilzomib · Ixazomib | 30 | 18 |
| L01XA | Carboplatin · Cisplatin · Oxaliplatin | 45 | 12 |
| L01XK | Niraparib · Niraparib And Abiraterone · Olaparib · Talazoparib | 12 | 7 |
| L01XL | Axicabtagene Ciloleucel · Brexucabtagene Autoleucel · Ciltacabtagene Autoleucel · Idecabtagene Vicleucel · Lifileucel · +2 more | 8 | 5 |
| L01XJ | Glasdegib · Sonidegib · Vismodegib | 4 | 4 |
| L01XD | Aminolevulinic Acid · Methyl Aminolevulinate · Porfimer Sodium | 5 | 3 |
| L01XH | Romidepsin · Vorinostat | 2 | 2 |
| L01XF | Tretinoin | 2 | 2 |
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.