OPZELURA 1.5 % — DIN 02552434
RUXOLITINIB (RUXOLITINIB PHOSPHATE) : 1.5 % · INCYTE CORPORATION · CREAM · wholesale supply in Canada
Health Canada status: MARKETED
What is OPZELURA?
OPZELURA 1.5 % contains RUXOLITINIB (RUXOLITINIB PHOSPHATE) : 1.5 %. It is listed in the Health Canada Drug Product Database under DIN 02552434, held by INCYTE CORPORATION, supplied as CREAM for TOPICAL administration. Health Canada currently lists it as marketed, status dated 28-Nov-2024. 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 OPZELURA used for?
OPZELURA (ruxolitinib (as ruxolitinib phosphate)) cream 1.5% is indicated for: • topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. • topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) or when those therapies are not advisable. Limitations of Use: Use of OPZELURA in combination with other JAK inhibitors, biological immunomodulators or potent immunosuppressants has not been studied and is not recommended.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ruxolitinib cost around the world?
Ruxolitinib is listed on 9 of the national price registers Nexara ingests. Each country publishes on a different basis, so 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; Greece publishes a producer price (ex-factory); Hungary publishes a 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 |
|---|---|---|---|
| Australia | ex-manufacturer | 1 | 22 |
| Saudi Arabia | public | 5 | 11 |
| Greece | producer price (ex-factory) | 5 | 5 |
| Iceland | max wholesale | 2 | 5 |
| Hungary | producer price (ex-factory) | 4 | 4 |
| Italy | ex-factory (classe H) | 4 | 4 |
| Romania | max producer price | 1 | 4 |
| Slovakia | categorised final price | 3 | 3 |
| Italy | prezzo al pubblico (classe A) | 1 | 2 |
| Luxembourg | reimbursement | 2 | 2 |
62 pack listings across 28 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Ruxolitinib 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 | 1.5 % |
|---|---|
| Dosage form | CREAM |
| Route | TOPICAL |
| Pack configuration (monograph) | 5 g (sample) aluminum tube with white high-density polyethylene (HDPE) caps. 60 g and 100 g aluminum tubes with polypropylene (PP) caps or laminate polyfoil tubes with PP caps. |
| Storage | Store OPZELURA at room temperature, 15°C to 25°C. Keep out of reach and sight of children. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Ruxolitinib |
|---|---|
| ATC code | D11AH09 |
| 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) | 02552434 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2552434 |
| Brand name | OPZELURA |
| Generic / active ingredient | RUXOLITINIB (RUXOLITINIB PHOSPHATE) : 1.5 % |
| Market authorization holder | INCYTE CORPORATION |
| Health Canada schedule | Prescription |
| ATC code | D11AH09 |
| ATC anatomical main group | D — Dermatologicals |
| ATC therapeutic subgroup | D11AH |
| Current status | MARKETED |
| Status date | 28-Nov-2024 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use. In order to avoid ingestion of cream, do not apply to the lips. OPZELURA should be applied topically twice daily to affected areas of skin with a minimum of 8 hours between applications. Patients should be instructed to wash their hands after applying OPZELURA, unless their hands are being treated. If someone else applies OPZELURA onto the patient, they should wash their hands after application. Vitiligo: Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. The recommended dose is a thin layer of OPZELURA applied twice daily to affected skin areas up to a maximum of 10% of body surface area (BSA) for each application. Satisfactory patient response may require treatment with OPZELURA for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, consider re-evaluation by the healthcare provider. Atopic Dermatitis: Adult and Pediatric Patients 12 Years of Age and Older: Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Pediatric Patients 2 to 11 Years of Age: Do not use more than one 60 gram tube per 2 weeks or one 100 gram tube per 4 weeks. The recommended dose is a thin layer of OPZELURA applied twice daily to affected skin areas up to a maximum of 20% of body surface area (BSA) for each application. Total BSA calculation excludes the scalp. Discontinue use when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, consider re-evaluation by the healthcare provider. Missed Dose: If a dose is missed, resume application at the next regularly scheduled time.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
OPZELURA 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
SERIOUS INFECTIONS: Serious bacterial, mycobacterial, fungal and viral infections including viral reactivation and other opportunistic infections (in some cases life-threatening or fatal) have been reported in patients treated with oral JAK inhibitors, including oral ruxolitinib (for noninflammatory conditions). Reported infections included: Tuberculosis, Herpes Zoster, JC Virus, Hepatitis B and Pneumonia. Patients with risk factors should be carefully assessed and monitored for the risk of developing serious infections. MALIGNANCIES: In a large, randomized, post-marketing safety study with an oral JAK inhibitor in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased risk of lymphoma and other malignancies, excluding non-melanoma skin cancers (NMSCs), was observed compared to those treated with TNF blockers. OPZELURA is not indicated for rheumatoid arthritis. The benefits and risks should be evaluated for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. THROMBOSIS: Thromboembolic events were observed in clinical trials with OPZELURA in patients with vitiligo and atopic dermatitis (AD). In a large, randomized, post-marketing safety study with an oral JAK inhibitor in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis, was observed compared to those treated with TNF blockers. OPZELURA is not indicated for rheumatoid arthritis. OPZELURA should be avoided in patients with a known risk of thrombosis. If symptoms of thrombosis occur, discontinue OPZELURA and evaluate and treat appropriately. MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): MACE were observed in clinical trials with OPZELURA in patients with AD. In a large, randomized, post-marketing safety study with an oral JAK inhibitor in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of MACE, including non-fatal myocardial infarction, was observed compared to those treated with TNF blockers. OPZELURA is not indicated for rheumatoid arthritis. The benefits and risks for the individual patient should be evaluated prior to initiating or continuing therapy with OPZELURA in patients who are current or past smokers or patients with cardiovascular risk factors. Non-melanoma Skin Cancer: NMSCs, including basal cell carcinoma and squamous cell carcinoma, were observed in patients with vitiligo and AD treated with OPZELURA. A skin examination prior to initiation and periodically during treatment with OPZELURA should be considered for patients with a history of skin cancers or who have risk factors for the development of skin cancers. Decrease in Blood Cell Count: Thrombocytopenia, anemia, and neutropenia were reported in clinical trials with OPZELURA in patients with vitiligo and AD. Consider the benefits and risks for individual patients who have a known history of thrombocytopenia, anemia, or neutropenia prior to initiating therapy with OPZELURA. If clinically indicated, consider monitoring complete blood count in these patients. If clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA. Infections: Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection, a history of a serious or an opportunistic infection, who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or w
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 D11AH
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Dupilumab | DUPIXENT | 5 | 4 | Yes |
| Abrocitinib | CIBINQO | 3 | 3 | Yes |
| Alitretinoin | HANZEMA · PANRETIN · TOCTINO | 5 | 2 | Yes |
| Tacrolimus | LEO PHARMA - TACROLIMUS · PROTOPIC | 4 | 2 | Yes |
| Tralokinumab | ADTRALZA | 2 | 2 | Yes |
| Lebrikizumab | EBGLYSS | 2 | 2 | Yes |
| Pimecrolimus | ELIDEL | 1 | 1 | Yes |
| Ruxolitinib | OPZELURA | 1 | 1 | Yes |
| Delgocitinib | ANZUPGO | 1 | 1 | Yes |
| Crisaborole | EUCRISA | 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 D11A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| D11AX | Brimonidine · Deoxycholic Acid · Eflornithine · Finasteride · Hydroquinone · +6 more | 466 | 88 |
| D11AF | Wart And Anti-Corn Preparations | 33 | 1 |
| D11AA | Antihidrotics | 397 | 0 |
| D11AC | Cetrimide · Medicated Shampoos · Others · Povidone-Iodine · Selenium Compounds · +1 more | 27 | 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 OPZELURA called?
Also recorded in Canada as: JAKAVI (GLOBAL), JAKAFY (US), RUXOLITINIB (GLOBAL), RUXOLITINIB PHOSPHATE (US), RUXOLITINIB PHOSPHATE (UK), RUXOLITINIB PHOSPHATE (JP), RUXOLITINIBUM (GLOBAL).
The same molecule, Ruxolitinib, 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 |
|---|---|---|
| Jakavi | Latin | Australia, Iceland, Romania |
| Celezon | Latin | Saudi Arabia |
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.