ZORYVE 0.3 % — DIN 02537532
ROFLUMILAST : 0.3 % · ARCUTIS CANADA, INC. · CREAM · wholesale supply in Canada
Health Canada status: MARKETED
What is ZORYVE?
ZORYVE 0.3 % contains ROFLUMILAST : 0.3 %. It is listed in the Health Canada Drug Product Database under DIN 02537532, held by ARCUTIS CANADA, INC., supplied as CREAM for TOPICAL administration. Health Canada currently lists it as marketed, status dated 29-Apr-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.
What is ZORYVE used for?
ZORYVE® (roflumilast cream, 0.3%) is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older. ZORYVE® (roflumilast foam, 0.3%) is indicated for topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older. ZORYVE® (roflumilast cream, 0.15%) is indicated for topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. ZORYVE® (roflumilast foam, 0.3%) is indicated for topical treatment of seborrheic dermatitis in patients 9 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 Roflumilast cost around the world?
Roflumilast is listed on 12 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); Bahrain publishes a retail (max); 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 |
|---|---|---|---|---|
| United States | acquisition | 2 | 34 | USD███.██ |
| Sweden | AIP (pharmacy purchase price) | 4 | 15 | SEK███.██ |
| Norway | max AUP (pharmacy retail) | 3 | 9 | NOK███.██ |
| Saudi Arabia | public | 2 | 5 | SAR███.██ |
| Czechia | max producer price (ex-factory) | 2 | 4 | CZK███.██ |
| Spain | PVP con IVA (public price) | 4 | 4 | EUR███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
| Italy | prezzo al pubblico (classe A) | 2 | 2 | EUR███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
| Slovakia | categorised final price | 1 | 1 | EUR███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
81 pack listings across 27 brand entries and 12 price bases, refreshed 07 Sep 2026. Ranges span every Roflumilast 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 Roflumilast 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.
Only one market authorization holder has a Canadian DIN containing Roflumilast — 3 DINs, of which 3 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| ARCUTIS CANADA, INC. | 3 | 3 | ZORYVE | Sourceable in Canada |
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 | 0.3 % |
|---|---|
| Dosage form | CREAM |
| Route | TOPICAL |
| Pack configuration (monograph) | ZORYVE cream contains either 0.15% or 0.3% roflumilast (w/w) in a white to off-white cream and is supplied in 5-g (physician sample) and 60-g aluminum tubes. ZORYVE foam contains 0.3% roflumilast (w/w) in a white to off-white foam and is supplied in 25-g (physician sample) and 60-g pressurized aluminum cans. |
| Storage | Store at 15°C to 30°C. Keep out of reach and sight of children. Do not freeze ZORYVE foam. Do not puncture or incinerate container. Do not expose ZORYVE foam to heat or temperature above 50°C. Store ZORYVE foam in an upright position. This product in this pressurized can is very flammable. Do not use in the presence of open flame or spark. Do not expose to temperatures above 50°C. Do not puncture or burn the can. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Roflumilast |
|---|---|
| ATC code | D05AX06 |
| 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) | 02537532 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2537532 |
| Brand name | ZORYVE |
| Generic / active ingredient | ROFLUMILAST : 0.3 % |
| Market authorization holder | ARCUTIS CANADA, INC. |
| Health Canada schedule | Prescription |
| ATC code | D05AX06 |
| ATC anatomical main group | D — Dermatologicals |
| ATC therapeutic subgroup | D05AX |
| Current status | MARKETED |
| Status date | 29-Apr-2025 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Apply ZORYVE to affected areas once daily. Apply ZORYVE topically once a day to affected areas of skin and rub in completely. Wash hands after application unless hands are being treated. If deemed medically necessary to use during breastfeeding, use ZORYVE on the smallest area of skin for the shortest duration possible. Do not apply ZORYVE directly to the nipple or areola to avoid direct infant exposure. ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use. Advise patients if they forget to use ZORYVE as directed that they may skip the missed application and go back to their regular schedule the following day.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). ZORYVE 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
ZORYVE should not be used during labor and delivery. There are no human studies that have investigated effects of ZORYVE on preterm labor or labor at term; however, animal studies showed that oral roflumilast disrupted the labor and delivery process in mice. There are no adequate and well controlled studies of oral or topical roflumilast in pregnant women. The potential risk for humans is unknown. Studies of oral roflumilast in animals have shown reproductive toxicity at doses above the human recommended dose. ZORYVE should only be used by a breastfeeding mother if deemed medically necessary, considering a potential risk to the baby. To minimize potential exposure to the breastfed infant via breast milk, use ZORYVE on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply ZORYVE directly to the nipple or areola to avoid direct infant exposure. There is no information regarding the presence of topically administered roflumilast in human milk, the effects on the breastfed infant, or the effects on milk production. Oral roflumilast and/or its metabolites are excreted into the milk of lactating rats. Excretion of roflumilast and/or its metabolites into human milk is probable. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZORYVE and any potential adverse effects on the breastfed infant from ZORYVE or from the underlying maternal condition. The propellants in ZORYVE foam are very flammable. Do not use in presence of open flame or spark.
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
3 of 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ZORYVE | 0.3 % | FOAM | ARCUTIS CANADA, INC. | MARKETED | 02552566 |
| ZORYVE | 0.15 % | CREAM | ARCUTIS CANADA, INC. | MARKETED | 02556146 |
2 · Same class — other molecules in ATC D05AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Calcipotriol, Combinations | DOVOBET GEL · DOVOBET OINTMENT · ENSTILAR · TARO-CALCIPOTRIOL / BETAMETHASONE GEL | 4 | 4 | Yes |
| Roflumilast | ZORYVE | 3 | 3 | Yes |
| Tazarotene | ARAZLO · DUOBRII · TAZORAC | 6 | 2 | Yes |
| Calcipotriol | DOVONEX · DOVONEX - CRM 50MCG/GM · DOVONEX SOLUTION - TOP 50MCG/ML | 3 | 1 | Yes |
| Tapinarof | NDUVRA | 1 | 1 | Yes |
| Calcitriol | SILKIS | 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 D05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| D05AA | Tars | 100 | 4 |
| D05AC | Dithranol | 8 | 0 |
| D05AD | Methoxalen, Topical | 2 | 0 |
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 ZORYVE called?
Also recorded in Canada as: roflumilast 0.5 MG Oral Tablet [Daliresp] (US), roflumilast 0.25 MG Oral Tablet [Daliresp] (US), roflumilast 3 MG/ML Topical Cream [Zoryve] (US), roflumilast 3 MG/ML Topical Foam [Zoryve] (US), roflumilast 1.5 MG/ML Topical Cream [Zoryve] (US), roflumilast 0.5 MG/ML Topical Cream [Zoryve] (US), roflumilast 0.5 MG Oral Tablet (US), roflumilast 0.25 MG Oral Tablet (US), roflumilast 3 MG/ML Topical Cream (US), roflumilast 3 MG/ML Topical Foam (US), roflumilast 1.5 MG/ML Topical Cream (US), roflumilast 0.5 MG/ML Topical Cream (US), ROFLUMILAST (US), Daxas (EU), Daliresp (US).
The same molecule, Roflumilast, 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 |
|---|---|---|
| Daxas | Latin | Czechia, Norway, Sweden |
| Roflumilast Accord | Latin | Norway, Sweden |
| Firekol | Latin | Norway |
| RUMIXAFEN | Latin | Czechia |
| LEMITAT | Latin | Bahrain |
| Roflumilast Medartuum | Latin | Sweden |
| Roflumilast Orifarm | Latin | Sweden |
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.