ATECTURA BREEZHALER 80 MCG — DIN 02498685
MOMETASONE FUROATE : 80 MCG INDACATEROL (INDACATEROL ACETATE) : 150 MCG · NOVARTIS PHARMACEUTICALS CANADA INC · CAPSULE · wholesale supply in Canada
Health Canada status: MARKETED
What is ATECTURA BREEZHALER?
ATECTURA BREEZHALER 80 MCG contains MOMETASONE FUROATE : 80 MCG INDACATEROL (INDACATEROL ACETATE) : 150 MCG. It is listed in the Health Canada Drug Product Database under DIN 02498685, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as CAPSULE for INHALATION administration. Health Canada currently lists it as marketed, status dated 19-Aug-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 ATECTURA BREEZHALER used for?
ATECTURA BREEZHALER (indacaterol/mometasone furoate) is a combination of a long-acting beta 2 - adrenergic agonist (LABA) and an inhaled corticosteroid (ICS) indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. ATECTURA BREEZHALER should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as ICS or whose disease severity clearly warrants treatment with both a LABA and an ICS.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Indacaterol And Mometasone cost around the world?
Indacaterol And Mometasone is listed on 12 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); Bahrain publishes a retail (max). 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 | 16 | AUD███.██ |
| Austria | KVP (Kassenverkaufspreis) | 4 | 8 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 3 | 7 | CZK███.██ |
| Luxembourg | reimbursement | 6 | 6 | EUR███.██ |
| South Africa | single exit price | 6 | 6 | ZAR███.██ |
| Belgium | public | 4 | 4 | EUR███.██ |
| Romania | max producer price | 3 | 4 | RON███.██ |
| Bahrain | retail (max) | 2 | 2 | BHD███.██ |
| Spain | PVP con IVA (public price) | 2 | 2 | EUR███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| Iceland | max wholesale | 1 | 2 | ISK███.██ |
61 pack listings across 39 brand entries and 11 price bases, refreshed 08 Sep 2026. Ranges span every Indacaterol And Mometasone 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 Indacaterol And Mometasone 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.
Only one market authorization holder has a Canadian DIN containing Indacaterol And Mometasone — 3 DINs, of which 3 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| NOVARTIS PHARMACEUTICALS CANADA INC | 3 | 3 | ATECTURA BREEZHALER | 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 | 80 MCG |
|---|---|
| Dosage form | CAPSULE |
| Route | INHALATION |
| Pack configuration (monograph) | Carton of 30 ATECTURA BREEZHALER capsules (3 blister cards of 10 capsules) and one ATECTURA BREEZHALER device. |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Indacaterol And Mometasone |
|---|---|
| ATC code | R03AK14 |
| AHFS class | 12:12.08.12 ; 68:04.00 |
| 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) | 02498685 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2498685 |
| Brand name | ATECTURA BREEZHALER |
| Generic / active ingredient | MOMETASONE FUROATE : 80 MCG INDACATEROL (INDACATEROL ACETATE) : 150 MCG |
| Market authorization holder | NOVARTIS PHARMACEUTICALS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | R03AK14 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03AK |
| Current status | MARKETED |
| Status date | 19-Aug-2020 |
| Original market date | 2020-08-19 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
3 of 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ATECTURA BREEZHALER | 150 MCG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | 02498693 |
| ATECTURA BREEZHALER | 150 MCG | CAPSULE | NOVARTIS PHARMACEUTICALS CANADA INC | MARKETED | 02498707 |
2 · Same class — other molecules in ATC R03AK
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Salmeterol And Fluticasone | ADVAIR · ADVAIR 100 DISKUS · ADVAIR 250 DISKUS · ADVAIR 500 DISKUS · +3 more | 14 | 11 | Yes |
| Indacaterol And Mometasone | ATECTURA BREEZHALER | 3 | 3 | Yes |
| Formoterol And Budesonide | SYMBICORT 100 TURBUHALER · SYMBICORT 200 TURBUHALER · SYMBICORT FORTE TURBUHALER | 3 | 2 | Yes |
| Formoterol And Mometasone | ZENHALE | 3 | 2 | Yes |
| Vilanterol And Fluticasone Furoate | BREO ELLIPTA | 2 | 2 | Yes |
| Salbutamol And Sodium Cromoglicate | COMBIVENT INHALATION AEROSOL | 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 R03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03AC | Fenoterol · Formoterol · Indacaterol · Olodaterol · Pirbuterol · +4 more | 81 | 15 |
| R03AL | Fenoterol And Ipratropium Bromide · Formoterol And Aclidinium Bromide · Formoterol And Glycopyrronium Bromide · Formoterol, Glycopyrronium Bromide And Beclometasone · Formoterol, Glycopyrronium Bromide And Budesonide · +6 more | 18 | 11 |
| R03AA | Epinephrine | 4 | 0 |
| R03AB | Isoprenaline · Orciprenaline | 6 | 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 ATECTURA BREEZHALER called?
The same molecule, Indacaterol And Mometasone, 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 |
|---|---|---|
| Enerzair Breezhaler | Latin | Australia, Czechia, Iceland |
| Onbrez | Latin | Australia |
| ONBREZ BREEZHALER | Latin | Bahrain, Czechia |
| Ultibro Breezhaler | Latin | Bahrain, 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.