TRACLEER 125 MG
BOSENTAN (BOSENTAN MONOHYDRATE) : 125 MG · DIN 02244982 · JANSSEN INC
Health Canada status: MARKETED
What is TRACLEER?
TRACLEER 125 MG contains BOSENTAN (BOSENTAN MONOHYDRATE) : 125 MG. It is listed in the Health Canada Drug Product Database under DIN 02244982, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 18-Oct-2019. 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 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.
Product details and regulatory record
| DIN | 02244982 |
|---|---|
| Brand name | TRACLEER |
| Generic / active ingredient | BOSENTAN (BOSENTAN MONOHYDRATE) : 125 MG |
| Manufacturer | JANSSEN INC |
| Strength | 125 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C02KX01 BOSENTAN |
| AHFS class | 48:48.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 18-Oct-2019 |
| Original market date | 2001-12-14 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02244982 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2244982 |
| Brand name | TRACLEER |
| Active ingredient / INN | BOSENTAN (BOSENTAN MONOHYDRATE) : 125 MG |
| ATC code | C02KX01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C02 |
| AHFS class | 48:48.12 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | JANSSEN INC |
Which pack is which?
| Strength on the label | 125 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
What can be used instead?
Other Canadian products sharing ATC code C02KX01 BOSENTAN. 6 of 32 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| PMS-BOSENTAN | 125 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02383020 |
| PMS-BOSENTAN | 62.5 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02383012 |
| TARO-BOSENTAN | 125 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02483149 |
| TARO-BOSENTAN | 62.5 MG | TABLET | TARO PHARMACEUTICALS INC | MARKETED | DIN 02483130 |
| TRACLEER | 62.5 MG | TABLET | JANSSEN INC | MARKETED | DIN 02244981 |
| ACCEL-BOSENTAN | 125 MG | TABLET | ACCEL PHARMA INC | CANCELLED PRE MARKET | DIN 02435403 |
| ACT BOSENTAN | 125 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02386208 |
| ACT BOSENTAN | 62.5 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02386194 |
| ALEMBIC-BOSENTAN | 125 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | DIN 02423065 |
| ALEMBIC-BOSENTAN | 62.5 MG | TABLET | ALEMBIC PHARMACEUTICALS LIMITED | APPROVED | DIN 02423057 |
Who else supplies BOSENTAN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BOSENTAN appears in 262 registered pack listings across 13 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.
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.