ORKAMBI 125 MG — DIN 02451379
IVACAFTOR : 125 MG LUMACAFTOR : 200 MG · VERTEX PHARMACEUTICALS (CANADA) INCORPORATED · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is ORKAMBI?
ORKAMBI 125 MG contains IVACAFTOR : 125 MG LUMACAFTOR : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02451379, held by VERTEX PHARMACEUTICALS (CANADA) INCORPORATED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 27-Jan-2016. 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 ORKAMBI used for?
ORKAMBI (lumacaftor/ivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients 1 year of age and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ivacaftor And Lumacaftor cost around the world?
Ivacaftor And Lumacaftor 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; Austria publishes a KVP (Kassenverkaufspreis); Brazil publishes a preco fabrica (ex-factory ceiling). 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 | 1 | 20 | AUD███.██ |
| Luxembourg | reimbursement | 14 | 14 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 10 | 12 | EUR███.██ |
| Romania | max producer price | 7 | 12 | RON███.██ |
| Iceland | max wholesale | 2 | 8 | ISK███.██ |
| Italy | prezzo al pubblico (classe A) | 7 | 7 | EUR███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 2 | 5 | BRL███.██ |
| Czechia | max producer price (ex-factory) | 1 | 4 | CZK███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
83 pack listings across 45 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Ivacaftor And Lumacaftor 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 Ivacaftor And Lumacaftor 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 Ivacaftor And Lumacaftor — 5 DINs, of which 5 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 |
|---|---|---|---|---|
| VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | 5 | 5 | ORKAMBI | 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 | 125 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Orkambi Tablets (100 mg / 125 mg): 112 tablets (supplied in a box containing 4 cartons, with each carton containing 7 blister strips with 4 tablets per strip). Orkambi Tablets (200 mg / 125 mg): 112 tablets (supplied in a box containing 4 cartons, with each carton containing 7 blister strips, with 4 tablets per strip). Orkambi Granules (75 mg / 94 mg) 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 75 mg/ 94 mg granules per printed foil laminate packet). Orkambi Granules (100 mg / 125 mg): 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 100 mg / 125 mg granules per printed foil laminate packet). Orkambi Granules (150 mg / 188 mg): 56 packets (supplied in a box containing 4 wallets, with each wallet containing 14 packets of 150 mg / 188 mg granules per printed foil laminate packet). |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Ivacaftor And Lumacaftor |
|---|---|
| ATC code | R07AX30 |
| AHFS class | 48:14.04 ; 48:14.12 |
| 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) | 02451379 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2451379 |
| Brand name | ORKAMBI |
| Generic / active ingredient | IVACAFTOR : 125 MG LUMACAFTOR : 200 MG |
| Market authorization holder | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED |
| Health Canada schedule | Prescription |
| ATC code | R07AX30 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R07AX |
| Current status | MARKETED |
| Status date | 27-Jan-2016 |
| Original market date | 2016-01-27 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
5 of 5 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ORKAMBI | 125 MG | TABLET | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | 02463040 |
| ORKAMBI | 100 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | 02483831 |
| ORKAMBI | 150 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | 02483858 |
| ORKAMBI | 94 MG | GRANULES | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | MARKETED | 02537087 |
2 · Same class — other molecules in ATC R07AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Ivacaftor | KALYDECO | 5 | 5 | Yes |
| Ivacaftor And Lumacaftor | ORKAMBI | 5 | 5 | Yes |
| Ivacaftor, Tezacaftor And Elexacaftor | TRIKAFTA | 4 | 4 | Yes |
| Nitric Oxide | INOMAX · KINOX · NOXIVENT | 6 | 2 | Yes |
| Other Respiratory System Products | ALYFTREK · STERILE WATER FOR INHALATION USP | 3 | 2 | Yes |
| Ivacaftor And Tezacaftor | SYMDEKO | 1 | 1 | Yes |
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 R07A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R07AA | Colfosceril Palmitate · Natural Phospholipids | 6 | 3 |
| R07AB | Doxapram | 2 | 0 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| BLES | PHOSPHOLIPID : 27 MG SURFACTANT-ASSOCIATED PROTEINS SP-B AND SP-C : 500 MCG | BLES BIOCHEMICALS INC | MARKETED | 02245464 |
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 ORKAMBI called?
The same molecule, Ivacaftor And Lumacaftor, 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 |
|---|---|---|
| Kalydeco | Latin | Australia, Brazil, Iceland |
| Kaftrio | Latin | Czechia, Iceland |
| SYMDEKO | Latin | Brazil |
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.