WINLEVI 1 % — DIN 02538881
CLASCOTERONE : 1 % · SUN PHARMACEUTICAL INDUSTRIES LIMITED · CREAM · wholesale supply in Canada
Health Canada status: MARKETED
What is WINLEVI?
WINLEVI 1 % contains CLASCOTERONE : 1 %. It is listed in the Health Canada Drug Product Database under DIN 02538881, held by SUN PHARMACEUTICAL INDUSTRIES LIMITED, supplied as CREAM for TOPICAL administration. Health Canada currently lists it as marketed, status dated 08-Sep-2023. 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 WINLEVI used for?
WINLEVI (clascoterone) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Clascoterone cost around the world?
Clascoterone is listed on 2 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. Bahrain publishes a retail (max); Saudi Arabia publishes a public. 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 |
|---|---|---|---|---|
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
| Saudi Arabia | public | 1 | 1 | SAR███.██ |
2 pack listings across 2 brand entries and 2 price bases, refreshed 01 Sep 2026. Ranges span every Clascoterone 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 | 1 % |
|---|---|
| Dosage form | CREAM |
| Route | TOPICAL |
| Pack configuration (monograph) | WINLEVI is supplied in 30 gram and 60 gram aluminum tubes. Health professional samples are supplied in 2 gram and 10 gram aluminum tubes. |
| Storage | Prior to Dispensing: Store the product in a refrigerator between 2°C and 8°C. Do not freeze. Dispensing Instructions for the Pharmacist: Direct the patient to store the product while in use at room temperature (20°C to 25°C). Do not freeze. Discard the unused product 180 days after the date of dispensing or 1 month after first opening, whichever is sooner. Keep out of the reach and sight of children. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Clascoterone |
|---|---|
| ATC code | D10AX06 |
| 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) | 02538881 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2538881 |
| Brand name | WINLEVI |
| Generic / active ingredient | CLASCOTERONE : 1 % |
| Market authorization holder | SUN PHARMACEUTICAL INDUSTRIES LIMITED |
| Health Canada schedule | Prescription |
| ATC code | D10AX06 |
| ATC anatomical main group | D — Dermatologicals |
| ATC therapeutic subgroup | D10AX |
| Current status | MARKETED |
| Status date | 08-Sep-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
WINLEVI is for external use only. It is not for ophthalmic, oral or vaginal use. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. The recommended dose per application is up to approximately 1 gram, which corresponds to 2 fingertip units. The recommended dosing regimen for WINLEVI is to apply a thin uniform layer of cream twice per day, in the morning and the evening, over the area prone to acne, as instructed by a health professional. Do not spot treat for optimal efficacy. Cleanse the entire area to be treated and dry gently. After the skin is dry, apply a thin uniform layer of WINLEVI twice per day, in the morning and in the evening, over the area prone to acne, as instructed by a health professional. The recommended dose per application is up to approximately 1 gram, which corresponds to 2 fingertip units. Each fingertip unit (approximately 0.5 g) is the amount of cream squeezed along the index finger from the tip to the first joint. When spread on the skin, the cream is expected to cover an area approximately the size of two adult palms or one adult face. Hands should be washed before and after applying WINLEVI cream. Avoid accidental transfer of WINLEVI into eyes, lips, mouth, corners of the nose, or other mucous membranes. If contact with mucous membranes occurs, rinse immediately and thoroughly with water. If patients forget to take a dose of WINLEVI, they should be instructed to apply the next dose at the usual time. Patients should be instructed to not apply a double dose to make up for forgotten doses.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
WINLEVI 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.
Warnings and precautions
Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. All Phase 2 maximum use clinical-trial subjects with HPA-axis suppression returned to normal HPA axis function 4 weeks after stopping treatment. Conditions which augment systemic effects include use over large surface areas, prolonged use, concomitant use of corticosteroid-containing products, and the use of occlusive dressings. Pediatric patients may be more susceptible. If HPA axis suppression is suspected, consider withdrawing the drug. WINLEVI may induce local irritation (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. WINLEVI is for external use only. Not for ophthalmic, oral or vaginal use. WINLEVI should not be applied to cuts, abrasions, eczematous or sunburned skin. Avoid accidental transfer of WINLEVI into eyes, lips, mouth, corners of the nose, or other mucous membranes. If contact with mucous membranes occurs, rinse immediately and thoroughly with water.
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 D10AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Azelaic Acid | FINACEA | 1 | 1 | Yes |
| Clascoterone | WINLEVI | 1 | 1 | Yes |
| Dapsone | ACZONE | 1 | 1 | Yes |
| Aluminium Oxide | BRASIVOL FINE · BRASIVOL MEDIUM | 2 | 0 | Not in Canada |
| Various Combinations | ACNE AID SOAP 6.3% | 1 | 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 D10A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| D10AE | Benzoyl Peroxide · Benzoyl Peroxide, Combinations | 214 | 35 |
| D10AD | Adapalene · Adapalene, Combinations · Isotretinoin · Tretinoin · Tretinoin, Combinations · +1 more | 48 | 16 |
| D10AF | Chloramphenicol, Combinations · Clindamycin · Clindamycin, Combinations · Erythromycin, Combinations | 23 | 8 |
| D10AA | Corticosteroids,Combinations For Treatment Of Acne · Methylprednisolone | 3 | 0 |
| D10AB | Sulphur · Sulphur, Combinations | 33 | 0 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| CABTREO | CLINDAMYCIN PHOSPHATE 1.2 %; ADAPALENE 0.15 %; BENZOYL PEROXIDE 3.1 % | BAUSCH HEALTH, CANADA INC. | MARKETED | 02550423 |
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 WINLEVI called?
Also recorded in Canada as: clascoterone 10 MG/ML Topical Cream [Winlevi] (US), clascoterone 10 MG/ML Topical Cream (US), CLASCOTERONE (US), clascoterone (GLOBAL), clascoterone (UK), CB-03-01 (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.