GILENYA 0.5 MG — DIN 02365480
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) : 0.5 MG · NOVARTIS PHARMACEUTICALS CANADA INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is GILENYA?
GILENYA 0.5 MG contains FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02365480, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 28-Mar-2011. 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 GILENYA used for?
Monotherapy for relapsing-remitting multiple sclerosis (RRMS) in adults and pediatric patients (10 to <18 years) to reduce frequency of clinical exacerbations and delay physical disability.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fingolimod cost around the world?
Fingolimod is listed on 15 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; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 |
|---|---|---|---|---|
| Austria | KVP (Kassenverkaufspreis) | 11 | 22 | EUR███.██ |
| Sweden | AIP (pharmacy purchase price) | 14 | 18 | SEK███.██ |
| Czechia | max producer price (ex-factory) | 15 | 17 | CZK███.██ |
| Greece | producer price (ex-factory) | 15 | 15 | EUR███.██ |
| Slovakia | categorised final price | 15 | 15 | EUR███.██ |
| Italy | prezzo al pubblico (classe A) | 5 | 11 | EUR███.██ |
| United States | acquisition | 1 | 11 | USD███.██ |
| Australia | ex-manufacturer | 9 | 10 | AUD███.██ |
| Hungary | producer price (ex-factory) | 10 | 10 | HUF███.██ |
| Romania | max producer price | 6 | 6 | RON███.██ |
| Luxembourg | reimbursement | 4 | 4 | EUR███.██ |
| Iceland | max wholesale | 2 | 3 | ISK███.██ |
| Bahrain | retail (max) | 2 | 2 | BHD███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
147 pack listings across 112 brand entries and 14 price bases, refreshed 08 Sep 2026. Ranges span every Fingolimod 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 Fingolimod 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.
11 holders have a Canadian DIN containing Fingolimod, 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 |
|---|---|---|---|---|
| NOVARTIS PHARMACEUTICALS CANADA INC | 2 | 2 | GILENYA | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 1 | 1 | ACH-FINGOLIMOD | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP FINGOLIMOD | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 1 | 1 | MYLAN-FINGOLIMOD | Sourceable in Canada |
| PHARMASCIENCE INC | 1 | 1 | PMS-FINGOLIMOD | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | SANDOZ FINGOLIMOD | Sourceable in Canada |
| TARO PHARMACEUTICALS INC | 1 | 1 | TARO-FINGOLIMOD | Sourceable in Canada |
| APOTEX INC | 1 | 0 | APO-FINGOLIMOD | No marketed DIN |
| ASCEND LABORATORIES LTD | 1 | 0 | ASN-FINGOLIMOD | No marketed DIN |
| MARCAN PHARMACEUTICALS INC | 1 | 0 | MAR-FINGOLIMOD | No marketed DIN |
| TEVA CANADA LIMITED | 1 | 0 | TEVA-FINGOLIMOD | 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 | 0.5 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | 0.5 mg: Cartons of 7 or 28 capsules (blister cards). 0.25 mg: Cartons of 28 capsules (blister cards). |
| Storage | Not explicitly detailed in provided text snippet (Table of Contents points to section 11). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Fingolimod |
|---|---|
| ATC code | L04AE01 |
| 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) | 02365480 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2365480 |
| Brand name | GILENYA |
| Generic / active ingredient | FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) : 0.5 MG |
| Market authorization holder | NOVARTIS PHARMACEUTICALS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | L04AE01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L04AE |
| Current status | MARKETED |
| Status date | 28-Mar-2011 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults: 0.5 mg daily. Pediatrics (10-17 years): 0.25 mg (<=40 kg) or 0.5 mg (>40 kg) daily. Requires 6-hour cardiac monitoring after first dose. Taken with or without food.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity; risk of opportunistic infections; severe active infections; active malignancies; severe hepatic impairment; recent (6 months) MI, unstable angina, stroke, or heart failure.
Warnings and precautions
Risk of bradyarrhythmia and AV block (requires monitoring); infections (VZV, PML); macular edema; respiratory effects; liver injury; skin cancer; posterior reversible encephalopathy syndrome.
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 |
|---|---|---|---|---|---|
| ACH-FINGOLIMOD | 0.5 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | 02475669 |
| GILENYA | 0.25 MG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | 02482533 |
| JAMP FINGOLIMOD | 0.5 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | 02487772 |
| MYLAN-FINGOLIMOD | 0.5 MG | CAPSULE | MYLAN PHARMACEUTICALS ULC | MARKETED | 02469715 |
| PMS-FINGOLIMOD | 0.5 MG | CAPSULE | PHARMASCIENCE INC | MARKETED | 02469782 |
| SANDOZ FINGOLIMOD | 0.5 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | 02482606 |
| TARO-FINGOLIMOD | 0.5 MG | CAPSULE | TARO PHARMACEUTICALS INC | MARKETED | 02469618 |
| APO-FINGOLIMOD | 0.5 MG | CAPSULE | APOTEX INC | DORMANT | 02469936 |
| ASN-FINGOLIMOD | 0.5 MG | CAPSULE | ASCEND LABORATORIES LTD | APPROVED | 02500914 |
| MAR-FINGOLIMOD | 0.5 MG | CAPSULE | MARCAN PHARMACEUTICALS INC | DORMANT | 02474743 |
2 · Same class — other molecules in ATC L04AE
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fingolimod | ACH-FINGOLIMOD · APO-FINGOLIMOD · ASN-FINGOLIMOD · GILENYA · +7 more | 12 | 8 | Yes |
| Siponimod | MAYZENT | 3 | 2 | Yes |
| Ozanimod | ZEPOSIA | 2 | 2 | Yes |
| Ponesimod | PONVORY | 2 | 1 | Yes |
| Etrasimod | VELSIPITY | 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 L04A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L04AX | Azathioprine · Dimethyl Fumarate · Lenalidomide · Methotrexate · Other Immunosuppressants · +3 more | 191 | 124 |
| L04AC | Anakinra · Basiliximab · Bimekizumab · Brodalumab · Canakinumab · +13 more | 85 | 75 |
| L04AB | Adalimumab · Certolizumab Pegol · Etanercept · Golimumab · Infliximab | 71 | 55 |
| L04AA | Abatacept · Alefacept · Antilymphocyte Immunoglobulin (Horse) · Antithymocyte Immunoglobulin (Rabbit) · Apremilast · +4 more | 73 | 42 |
| L04AD | Ciclosporin · Tacrolimus | 49 | 30 |
| L04AK | Leflunomide · Teriflunomide | 44 | 25 |
| L04AH | Everolimus · Sirolimus | 36 | 23 |
| L04AF | Baricitinib · Deucravacitinib · Ritlecitinib · Tofacitinib · Upadacitinib | 23 | 19 |
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 GILENYA called?
The same molecule, Fingolimod, 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 |
|---|---|---|
| GILENYA® | Latin | Sweden |
| Fingolimod STADA | Latin | Czechia, Sweden |
| Fingolimod Zentiva | Latin | Czechia, Iceland, Sweden |
| Fingolimod Accord | Latin | Czechia, Sweden |
| Fingolimod Glenmark | Latin | Czechia, Sweden |
| Fingolimod Mylan | Latin | Czechia, Sweden |
| Fingolimod Reddy | Latin | Czechia, Sweden |
| Fingolimod Teva | Latin | Sweden |
| GAXENIM | Latin | Czechia |
| AKM Fingolimod | Latin | Australia |
| Bonaxon | Latin | Slovakia |
| CHANTICO | Latin | Czechia |
| FILOSIR | Latin | Australia |
| FIMODIGO | Latin | Czechia |
| FINGOLIMOD +PHARMA | Latin | Czechia |
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.
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.