TRACLEER 62.5 MG — DIN 02244981
BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG · JANSSEN INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is TRACLEER?
TRACLEER 62.5 MG contains BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02244981, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Feb-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 TRACLEER used for?
TRACLEER ® (bosentan monohydrate) is indicated for the treatment of pulmonary arterial hypertension in patients with WHO functional class III or IV primary pulmonary hypertension, or pulmonary hypertension secondary to scleroderma or congenital heart disease or human immunodeficiency virus in patients who did not respond adequately to conventional therapy. A prolongation of time to clinical worsening was also shown in patients with WHO functional class II.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Bosentan cost around the world?
Bosentan is listed on 9 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; Bahrain publishes a retail (max); 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 |
|---|---|---|---|---|
| Australia | ex-manufacturer | 5 | 44 | AUD███.██ |
| Saudi Arabia | public | 11 | 15 | SAR███.██ |
| Italy | prezzo al pubblico (classe A) | 6 | 14 | EUR███.██ |
| Greece | producer price (ex-factory) | 13 | 13 | EUR███.██ |
| Sweden | AIP (pharmacy purchase price) | 5 | 13 | SEK███.██ |
| Hungary | producer price (ex-factory) | 4 | 4 | HUF███.██ |
| Romania | max producer price | 2 | 4 | RON███.██ |
| Bahrain | retail (max) | 1 | 3 | BHD███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Italy | ex-factory (classe H) | 1 | 1 | EUR███.██ |
113 pack listings across 50 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Bosentan 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 Bosentan 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.
17 holders have a Canadian DIN containing Bosentan, across 32 DINs, of which 6 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 |
|---|---|---|---|---|
| JANSSEN INC | 2 | 2 | TRACLEER | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-BOSENTAN | Sourceable in Canada |
| TARO PHARMACEUTICALS INC | 2 | 2 | TARO-BOSENTAN | Sourceable in Canada |
| ALEMBIC PHARMACEUTICALS LIMITED | 2 | 0 | ALEMBIC-BOSENTAN | No marketed DIN |
| APOTEX INC | 2 | 0 | APO-BOSENTAN | No marketed DIN |
| AURO PHARMA INC | 2 | 0 | AURO-BOSENTAN | No marketed DIN |
| BIOMED PHARMA | 2 | 0 | BIO-BOSENTAN | No marketed DIN |
| MARCAN PHARMACEUTICALS INC | 2 | 0 | MAR-BOSENTAN | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 2 | 0 | MYLAN-BOSENTAN | No marketed DIN |
| NATCO PHARMA (CANADA) INC | 2 | 0 | NAT-BOSENTAN | No marketed DIN |
| PANDA PHARMACEUTICALS INC. | 2 | 0 | BOSENTAN | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 2 | 0 | SANDOZ BOSENTAN | No marketed DIN |
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 | 62.5 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | 62.5 mg film - coated, round, biconvex, orange - white tablets debossed with '62,5' on one side in carton box containing 4 blisters of 14 tablets each (56 tablets in total). • 125 mg film - coated, oval, biconvex, orange - white tablets debossed with '125' on one side in carton box containing 4 blisters of 14 tablets each (56 tablets in total). |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Bosentan |
|---|---|
| ATC code | C02KX01 |
| AHFS class | 48:48.12 |
| 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) | 02244981 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2244981 |
| Brand name | TRACLEER |
| Generic / active ingredient | BOSENTAN (BOSENTAN MONOHYDRATE) : 62.5 MG |
| Market authorization holder | JANSSEN INC |
| Health Canada schedule | Prescription |
| ATC code | C02KX01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C02KX |
| Current status | MARKETED |
| Status date | 20-Feb-2020 |
| Original market date | 2001-12-14 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
6 of 32 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| PMS-BOSENTAN | 62.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02383012 |
| PMS-BOSENTAN | 125 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02383020 |
| TARO-BOSENTAN | 62.5 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | 02483130 |
| TARO-BOSENTAN | 125 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | 02483149 |
| TRACLEER | 125 MG | TABLET | JANSSEN INC | MARKETED | 02244982 |
| ACCEL-BOSENTAN | 125 MG | TABLET | ACCEL PHARMA INC | CANCELLED PRE MARKET | 02435403 |
| ACT BOSENTAN | 125 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | 02386208 |
| ACT BOSENTAN | 62.5 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | 02386194 |
| ALEMBIC-BOSENTAN | 62.5 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | 02423057 |
| ALEMBIC-BOSENTAN | 125 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | 02423065 |
2 · Same class — other molecules in ATC C02KX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Riociguat | ADEMPAS · SANDOZ RIOCIGUAT | 10 | 10 | Yes |
| Bosentan | ACCEL-BOSENTAN · ACT BOSENTAN · ALEMBIC-BOSENTAN · APO-BOSENTAN · +12 more | 32 | 6 | Yes |
| Antihypertensives For Pulmonary Arterial Hypertension | APO-SILDENAFIL R · FINASTERIDE · JAMP-SILDENAFIL R · PMS-SILDENAFIL R · +3 more | 8 | 5 | Yes |
| Ambrisentan | APO-AMBRISENTAN · AURO-AMBRISENTAN · JAMP AMBRISENTAN · M-AMBRISENTAN · +4 more | 16 | 4 | Yes |
| Sotatercept | WINREVAIR | 4 | 2 | Yes |
| Macitentan And Tadalafil | OPSYNVI | 1 | 1 | Yes |
| Macitentan | OPSUMIT | 1 | 1 | Yes |
| Sitaxentan | THELIN | 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 C02K
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| C02KN | Aprocitentan | 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 TRACLEER called?
The same molecule, Bosentan, 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 |
|---|---|---|
| Bosentan APO | Latin | Australia |
| BOSENTAN DR.REDDY'S | Latin | Australia |
| Bosentan RBX | Latin | Australia |
| Bosentan GH | Latin | Australia |
| Bosentan Viatris | Latin | Australia |
| Bosentan Accord | Latin | Sweden |
| Bosentan Aurobindo | Latin | Sweden |
| Bosentan OHRE Pharma | Latin | Saudi Arabia |
| Bosentan Sandoz | Latin | Sweden |
| Bosfit | Latin | Saudi Arabia |
| STAYVEER | 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.