VOLIBRIS 10 MG — DIN 02307073
AMBRISENTAN : 10 MG · GLAXOSMITHKLINE INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is VOLIBRIS?
VOLIBRIS 10 MG contains AMBRISENTAN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02307073, held by GLAXOSMITHKLINE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Jun-2008. 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 VOLIBRIS used for?
Treatment of idiopathic pulmonary arterial hypertension (IPAH) and PAH associated with connective tissue disease (WHO class II or III); initiation therapy in combination with tadalafil.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ambrisentan cost around the world?
Ambrisentan is listed on 15 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; Austria publishes a KVP (Kassenverkaufspreis); 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 |
|---|---|---|---|---|
| Australia | ex-manufacturer | 4 | 28 | AUD███.██ |
| Sweden | AIP (pharmacy purchase price) | 5 | 19 | SEK███.██ |
| Italy | prezzo al pubblico (classe A) | 10 | 11 | EUR███.██ |
| United States | acquisition | 1 | 9 | USD███.██ |
| Greece | producer price (ex-factory) | 8 | 8 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 3 | 8 | NOK███.██ |
| Saudi Arabia | public | 4 | 8 | SAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 6 | 6 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 3 | 5 | CZK███.██ |
| South Africa | single exit price | 4 | 4 | ZAR███.██ |
| Iceland | max wholesale | 2 | 3 | ISK███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
117 pack listings across 58 brand entries and 13 price bases, refreshed 08 Sep 2026. Ranges span every Ambrisentan 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 Ambrisentan 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.
7 holders have a Canadian DIN containing Ambrisentan, across 16 DINs, of which 4 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 |
|---|---|---|---|---|
| APOTEX INC | 2 | 2 | APO-AMBRISENTAN | Sourceable in Canada |
| GLAXOSMITHKLINE INC | 2 | 2 | VOLIBRIS | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 4 | 0 | SANDOZ AMBRISENTAN, SANDOZ AMBRISENTAN TABLETS | No marketed DIN |
| AURO PHARMA INC | 2 | 0 | AURO-AMBRISENTAN | No marketed DIN |
| JAMP PHARMA CORPORATION | 2 | 0 | JAMP AMBRISENTAN | No marketed DIN |
| MANTRA PHARMA INC | 2 | 0 | M-AMBRISENTAN | No marketed DIN |
| TEVA CANADA LIMITED | 2 | 0 | TEVA-AMBRISENTAN | 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 | 10 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Blister packs of 30 tablets. |
| Storage | Not explicitly detailed in provided text (standard section 11 header present but content truncated). |
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 | Ambrisentan |
|---|---|
| ATC code | C02KX02 |
| AHFS class | 48:48.00 |
| 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) | 02307073 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2307073 |
| Brand name | VOLIBRIS |
| Generic / active ingredient | AMBRISENTAN : 10 MG |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Prescription |
| ATC code | C02KX02 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C02KX |
| Current status | MARKETED |
| Status date | 24-Jun-2008 |
| Original market date | 2008-06-24 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Initiate at 5 mg once daily. May increase to 10 mg once daily. In combination with tadalafil, uptitrate both drugs over 8 weeks. Max dose 10 mg. Limit to 5 mg when used with cyclosporine A.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity; Pregnancy; Breastfeeding; Severe hepatic impairment; Baseline AST/ALT >3x ULN; Idiopathic pulmonary fibrosis (IPF).
Warnings and precautions
Fluid retention/peripheral edema; decreased hemoglobin/hematocrit (anemia); potential hepatotoxicity; pulmonary veno-occlusive disease risk; potential effect on male fertility.
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
4 of 16 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-AMBRISENTAN | 10 MG | TABLET | APOTEX INC | MARKETED | 02475383 |
| APO-AMBRISENTAN | 5 MG | TABLET | APOTEX INC | MARKETED | 02475375 |
| VOLIBRIS | 5 MG | TABLET | GLAXOSMITHKLINE INC | MARKETED | 02307065 |
| AURO-AMBRISENTAN | 10 MG | TABLET | AURO PHARMA INC | APPROVED | 02527103 |
| AURO-AMBRISENTAN | 5 MG | TABLET | AURO PHARMA INC | APPROVED | 02527081 |
| JAMP AMBRISENTAN | 5 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | 02521938 |
| JAMP AMBRISENTAN | 10 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | 02521946 |
| M-AMBRISENTAN | 10 MG | TABLET | MANTRA PHARMA INC | APPROVED | 02554097 |
| M-AMBRISENTAN | 5 MG | TABLET | MANTRA PHARMA INC | APPROVED | 02554089 |
| SANDOZ AMBRISENTAN | 10 MG | TABLET | SANDOZ CANADA INCORPORATED | CANCELLED PRE MARKET | 02525313 |
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 VOLIBRIS called?
The same molecule, Ambrisentan, 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 |
|---|---|---|
| Ambrisentan Viatris | Latin | Australia, Norway, Sweden |
| PULMORIS | Latin | Australia |
| Ambrisentan Accord | Latin | Czechia, Norway, Sweden |
| Cipla Ambrisentan | Latin | Australia |
| AMBRISENTAN ZENTIVA | Latin | Czechia |
| Ambracy | Latin | Saudi Arabia |
| Ambrisentan Bluefish | Latin | Sweden |
| AMBRISENTAN GENEPHARM | Latin | Saudi Arabia |
| Ambrisentan Sandoz | Latin | Sweden |
| Ambrisentan Mylan | Latin | Iceland |
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.