BLEXTEN 10 MG — DIN 02519038
BILASTINE : 10 MG · ARALEZ PHARMACEUTICALS CANADA INC · TABLET (ORALLY DISINTEGRATING) · wholesale supply in Canada
Health Canada status: MARKETED
What is BLEXTEN?
BLEXTEN 10 MG contains BILASTINE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02519038, held by ARALEZ PHARMACEUTICALS CANADA INC, supplied as TABLET (ORALLY DISINTEGRATING) for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Feb-2022. 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 BLEXTEN used for?
Symptomatic relief of seasonal allergic rhinitis (SAR) and chronic spontaneous urticaria (CSU) in patients 4 years of age and older with a body weight of at least 16 kg.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Bilastine cost around the world?
Bilastine is listed on 7 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); Czechia publishes a max producer price (ex-factory); Greece 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 | Range |
|---|---|---|---|---|
| Czechia | max producer price (ex-factory) | 5 | 14 | CZK███.██ |
| Greece | producer price (ex-factory) | 12 | 12 | EUR███.██ |
| Bahrain | retail (max) | 3 | 5 | BHD███.██ |
| Luxembourg | reimbursement | 4 | 4 | EUR███.██ |
| Saudi Arabia | public | 3 | 4 | SAR███.██ |
| United Arab Emirates | public | 3 | 3 | AED███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
44 pack listings across 32 brand entries and 6 price bases, refreshed 05 Sep 2026. Ranges span every Bilastine 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 Bilastine 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.
8 holders have a Canadian DIN containing Bilastine, across 10 DINs, of which 10 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 |
|---|---|---|---|---|
| ARALEZ PHARMACEUTICALS CANADA INC | 3 | 3 | BLEXTEN | Sourceable in Canada |
| AURO PHARMA INC | 1 | 1 | AURO-BILASTINE | Sourceable in Canada |
| GLENMARK PHARMACEUTICALS CANADA INC. | 1 | 1 | GLN-BILASTINE | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP BILASTINE | Sourceable in Canada |
| MANTRA PHARMA INC | 1 | 1 | M-BILASTINE | Sourceable in Canada |
| MARCAN PHARMACEUTICALS INC | 1 | 1 | MAR-BILASTINE | Sourceable in Canada |
| NORA PHARMA INC | 1 | 1 | NRA-BILASTINE | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | SANDOZ BILASTINE | 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 | 10 MG |
|---|---|
| Dosage form | TABLET (ORALLY DISINTEGRATING) |
| Route | ORAL |
| Pack configuration (monograph) | 10 mg orodispersible tablets: Blister packs of 10, cartons of 30. 20 mg tablets: Blister packs of 10, cartons of 30. 2.5 mg/mL oral solution: 120 mL amber glass bottle with dosing cup. |
| Storage | Not explicitly detailed in provided text snippet (refer to full monograph Section 11). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Bilastine |
|---|---|
| ATC code | R06AX29 |
| 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) | 02519038 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2519038 |
| Brand name | BLEXTEN |
| Generic / active ingredient | BILASTINE : 10 MG |
| Market authorization holder | ARALEZ PHARMACEUTICALS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | R06AX29 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R06AX |
| Current status | MARKETED |
| Status date | 10-Feb-2022 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
4-11 years (≥16 kg): 10 mg once daily. ≥12 years: 20 mg once daily. Take on an empty stomach 1 hour before or 2 hours after food or fruit juice.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to bilastine or any ingredient; history of QT prolongation and/or torsade de pointes, including congenital long QT syndromes.
Warnings and precautions
Associated with QTc interval prolongation; exercise care in patients with cardiac risks. Very rarely may cause drowsiness affecting driving. Avoid P-gp inhibitors in renal impairment.
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
10 of 10 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-BILASTINE | 20 MG | TABLET | AURO PHARMA INC | MARKETED | 02541556 |
| BLEXTEN | 2.5 MG | SOLUTION | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | 02519011 |
| BLEXTEN | 20 MG | TABLET | ARALEZ PHARMACEUTICALS CANADA INC | MARKETED | 02454130 |
| GLN-BILASTINE | 20 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | 02544369 |
| JAMP BILASTINE | 20 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02546795 |
| M-BILASTINE | 20 MG | TABLET | MANTRA PHARMA INC | MARKETED | 02548410 |
| MAR-BILASTINE | 20 MG | TABLET | MARCAN PHARMACEUTICALS INC | MARKETED | 02547279 |
| NRA-BILASTINE | 20 MG | TABLET | NORA PHARMA INC | MARKETED | 02551934 |
| SANDOZ BILASTINE | 20 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | 02536269 |
2 · Same class — other molecules in ATC R06AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Loratadine | 24 HOUR ALLERGY REMEDY · ALLERGY REMEDY · ALLERTIN · ALLERTIN TABLETS 10MG · +13 more | 20 | 11 | Yes |
| Bilastine | AURO-BILASTINE · BLEXTEN · GLN-BILASTINE · JAMP BILASTINE · +4 more | 10 | 10 | Yes |
| Rupatadine | APO-RUPATADINE · PMS-RUPATADINE · RIVA-RUPATADINE · RUPALL | 5 | 5 | Yes |
| Desloratadine | AERIUS · AERIUS KIDS · ALLERGY CONTROL DESLORATADINE · ALLERNIX MULTI SYMPTOM · +3 more | 9 | 4 | Yes |
| Cyproheptadine | EURO-CYPROHEPTADINE 2MG/5ML · EURO-CYPROHEPTADINE 4 MG/TABLET · JAMP CYPROHEPTADINE SYRUP · JAMP-CYPROHEPTADINE · +6 more | 10 | 3 | Yes |
| Fexofenadine | ALLEGRA 12 HOUR · ALLEGRA 24 HOUR · ALLEGRA HIVES | 3 | 3 | Yes |
| Ketotifen | APO-KETOTIFEN - SYR 1MG/5ML · NOVO-KETOTIFEN - SYR 1MG/5ML · NOVO-KETOTIFEN TAB 1MG · NU-KETOTIFEN SYRUP - 1MG/5ML · +3 more | 9 | 1 | Yes |
| Other Antihistamines For Systemic Use | APO-BILASTINE ORAL SOLUTION · APO-BILASTINE ORODISPERSIBLE TABLETS · APO-BILASTINE TABLETS | 3 | 1 | Yes |
| Terfenadine | ALLERGY RELIEF · APO-TERFENADINE TAB 120MG · APO-TERFENADINE TABLETS 60MG · NOVO-TERFENADINE TAB 60MG · +7 more | 11 | 0 | Not in Canada |
| Astemizole | HISMANAL - TAB 10MG · HISMANAL SUSPENSION 2MG/ML · HISMANAL TAB 10MG | 3 | 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 R06A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R06AA | Clemastine · Dimenhydrinate · Dimenhydrinate, Combinations · Diphenhydramine · Diphenhydramine, Combinations · +3 more | 264 | 76 |
| R06AE | Cetirizine · Cyclizine · Meclozine · Meclozine, Combinations | 69 | 27 |
| R06AB | Brompheniramine · Chlorpheniramine · Dexchlorpheniramine | 17 | 1 |
| R06AD | Alimemazine · Promethazine | 17 | 1 |
| R06AC | Tripelennamine | 1 | 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 BLEXTEN called?
The same molecule, Bilastine, 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 |
|---|---|---|
| Bilaxten | Latin | Bahrain, Saudi Arabia |
| BILASTIN TEVA | Latin | Czechia |
| XADOS | Latin | Czechia |
| BILASTINE GLENMARK | Latin | Czechia |
| BILASTINE MEDREG | Latin | Czechia |
| BILAZAP | Latin | Bahrain, Saudi Arabia |
| NESTIBIL | Latin | Czechia |
| Ilaxten | Latin | South Africa |
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.