NUBEQA 300 MG — DIN 02496348
DAROLUTAMIDE : 300 MG · BAYER INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is NUBEQA?
NUBEQA 300 MG contains DAROLUTAMIDE : 300 MG. It is listed in the Health Canada Drug Product Database under DIN 02496348, held by BAYER INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Mar-2020. 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 NUBEQA used for?
NUBEQA (darolutamide) is indicated for: • the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC). NUBEQA has not been studied in patients with nmCRPC at low risk of developing metastases (see 14 Clinical Trials). The benefit and risk profile in these patients is unknown. • the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). • the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Darolutamide cost around the world?
Darolutamide is listed on 10 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); Czechia publishes a max producer price (ex-factory). 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 | 2 | AUD███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
| Austria | KVP (Kassenverkaufspreis) | 1 | 1 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 1 | 1 | CZK███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Hungary | producer price (ex-factory) | 1 | 1 | HUF███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
| Italy | ex-factory (classe H) | 1 | 1 | EUR███.██ |
| Saudi Arabia | public | 1 | 1 | SAR███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
11 pack listings across 10 brand entries and 8 price bases, refreshed 08 Sep 2026. Ranges span every Darolutamide 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 | 300 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | NUBEQA (darolutamide) 300 mg tablet is presented as white to off-white film-coated oval tablets. The tablets are marked with BAYER on one side and with 300 on the other side. The product is supplied in 120 mL bottles of 120 tablets or blisters containing 112 tablets. |
| Storage | Store bottles or blisters at room temperature 15°C to 30°C. Keep out of sight and reach of children. Keep the bottle tightly closed after first opening. Once the bottle is opened the medicinal product has shown to be stable for 3 months. Do NOT use this medicine after the expiry date stated on the product labels. Use this medicine only for 3 months after you first open the bottle. The medicine may not be as effective after 3 months. Do NOT throw away any medicines in the garbage, down the sink or in the toilet. Ask your pharmacist how to throw away expired or unused NUBEQA. These measures will help protect the environment. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Darolutamide |
|---|---|
| ATC code | L02BB06 |
| 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) | 02496348 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2496348 |
| Brand name | NUBEQA |
| Generic / active ingredient | DAROLUTAMIDE : 300 MG |
| Market authorization holder | BAYER INC |
| Health Canada schedule | Prescription |
| ATC code | L02BB06 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L02BB |
| Current status | MARKETED |
| Status date | 24-Mar-2020 |
| Original market date | 2020-03-24 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dose is 600 mg (two film-coated tablets of 300 mg) NUBEQA taken twice daily, equivalent to a total daily dose of 1200 mg. NUBEQA should be continued until disease progression or unacceptable toxicity. If a patient experiences a Grade 3 or higher toxicity or an intolerable adverse reaction, dosing should be withheld or reduced to 300 mg twice daily until symptoms improve. Then treatment may be resumed at a dose of 600 mg twice daily. Dose reduction below 300 mg twice daily is not recommended. The maximum daily dose is 1200 mg (600 mg twice daily). When NUBEQA is used in combination with docetaxel, dosage and administration recommendations in the docetaxel product monograph should be followed. Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy. When used in combination with docetaxel for patients with mCSPC, the first cycle of docetaxel should be administered within 6 weeks after the start of NUBEQA treatment. Docetaxel should be administered every 3 weeks for up to 6 cycles. Treatment with NUBEQA should be continued until disease progression or unacceptable toxicity even if the administration of docetaxel is delayed, interrupted, or discontinued before completion of 6 cycles. For oral use. The tablets should be taken whole with food. If a dose of NUBEQA is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. The patient should not take two doses together to make up for a missed dose.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
NUBEQA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition, and Packaging.
Warnings and precautions
Cardiovascular: Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. Patients should be monitored for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Hepatic/Biliary/Pancreatic: Serious cases of drug-induced liver injury (DILI), including Hy's law cases, with increases in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) to ≥5x and ≥20x upper limit of normal (ULN), including with concomitant bilirubin elevations ≥2x ULN, have been reported in patients treated with NUBEQA. Monitor serum transaminases and bilirubin as per routine clinical practice. In case of liver function test abnormalities suggestive of idiosyncratic drug-induced liver injury, permanently discontinue NUBEQA. Neurologic: Seizure occurred in patients receiving NUBEQA. Consider withholding NUBEQA in patients who develop a seizure during treatment. Reproductive Health - Teratogenic Risk: Based on the mechanism of action, darolutamide can cause harm to the developing fetus or lead to loss of pregnancy. If the patient is engaged in sexual activity with a pregnant individual, a condom should be used during and for 3 months after completion of treatment with NUBEQA. If the patient is engaged in sexual activity with an individual of childbearing potential, a highly effective contraceptive method (<1% failure rate per year) should be used during and for 3 months after completion of treatment with NUBEQA to prevent pregnancy. Reproductive Health - Fertility: Based on animal studies, NUBEQA may impair fertility in patients of reproductive potential. Patients should not donate sperm during treatment and for 3 months after the last dose of NUBEQA.
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 L02BB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Bicalutamide | ACCEL-BICALUTAMIDE TABLETS USP · ACH-BICALUTAMIDE · ACT BICALUTAMIDE · AG-BICALUTAMIDE · +19 more | 25 | 6 | Yes |
| Apalutamide | ERLEADA | 2 | 2 | Yes |
| Flutamide | DOM-FLUTAMIDE · EUFLEX · FLUTAMIDE · FLUTAMIDE-250 · +4 more | 11 | 1 | Yes |
| Darolutamide | NUBEQA | 1 | 1 | Yes |
| Enzalutamide | XTANDI | 1 | 1 | Yes |
| Nilutamide | ANANDRON · ANANDRON - TAB 100MG · ANANDRON TAB 100MG · ANANDRON TAB 50MG | 6 | 0 | Not in Canada |
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 L02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L02BG | Aminogluthetimide · Anastrozole · Exemestane · Formestane · Letrozole | 79 | 39 |
| L02BX | Abiraterone · Degarelix · Relugolix | 27 | 20 |
| L02BA | Fulvestrant · Tamoxifen | 36 | 10 |
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 NUBEQA called?
Also recorded in Canada as: darolutamide 300 MG Oral Tablet [Nubeqa] (US), darolutamide 300 MG Oral Tablet (US), DAROLUTAMIDE (US), DAROLUTAMIDE (GLOBAL), DAROLUTAMIDE (UK), DAROLUTAMIDE (JP), ODM-201 (GLOBAL).
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.