TIVICAY 50 MG — DIN 02414945
DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) : 50 MG · VIIV HEALTHCARE ULC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is TIVICAY?
TIVICAY 50 MG contains DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02414945, held by VIIV HEALTHCARE ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Nov-2013. 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 TIVICAY used for?
Treatment of HIV-1 infection in adults and INSTI-naïve pediatric patients aged 4 weeks and older and weighing at least 3 kg, in combination with other antiretroviral agents.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Dolutegravir cost around the world?
Dolutegravir is listed on 13 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); Belgium publishes a public. 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 |
|---|---|---|---|---|
| South Africa | single exit price | 40 | 50 | ZAR███.██ |
| Belgium | public | 12 | 12 | EUR███.██ |
| Romania | max producer price | 7 | 7 | RON███.██ |
| Australia | ex-manufacturer | 4 | 4 | AUD███.██ |
| Bahrain | retail (max) | 3 | 4 | BHD███.██ |
| Italy | ex-factory (classe H) | 3 | 3 | EUR███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| Saudi Arabia | public | 2 | 2 | SAR███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 1 | 1 | BRL███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 1 | NOK███.██ |
| Slovakia | categorised final price | 1 | 1 | EUR███.██ |
90 pack listings across 79 brand entries and 11 price bases, refreshed 08 Sep 2026. Ranges span every Dolutegravir 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 Dolutegravir 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 Dolutegravir — 4 DINs, of which 2 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 |
|---|---|---|---|---|
| VIIV HEALTHCARE ULC | 4 | 2 | TIVICAY | 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 | 50 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | 10, 25, 50 mg tablets: Bottles of 30. 5 mg dispersible tablets: Kit with bottle of 60 tablets, dosing cup, and oral syringe. |
| Storage | Not explicitly detailed in provided text (standard storage section 11 mentioned in TOC but text cuts off). Packaging mentions silica gel desiccant. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Dolutegravir |
|---|---|
| ATC code | J05AJ03 |
| AHFS class | 08:18.08.12 |
| 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) | 02414945 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2414945 |
| Brand name | TIVICAY |
| Generic / active ingredient | DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) : 50 MG |
| Market authorization holder | VIIV HEALTHCARE ULC |
| Health Canada schedule | Prescription |
| ATC code | J05AJ03 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AJ |
| Current status | MARKETED |
| Status date | 08-Nov-2013 |
| Original market date | 2013-11-08 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults: 50 mg QD (naïve/INSTI-naïve) or 50 mg BID (INSTI-resistant). Pediatrics (>=4 weeks and >=3 kg): weight-based dosing. Dispersible tablets must be fully dispersed in water before swallowing.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to dolutegravir or any ingredient; co-administration with dofetilide or fampridine (dalfampridine).
Warnings and precautions
Hepatotoxicity (including acute liver failure), hypersensitivity reactions (discontinue immediately), Immune Reconstitution Inflammatory Syndrome (IRIS). Not bioequivalent across forms.
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
2 of 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| TIVICAY | 5 MG | TABLET FOR SUSPENSION | VIIV HEALTHCARE ULC | MARKETED | 02511517 |
| TIVICAY | 10 MG | TABLET | VIIV HEALTHCARE ULC | CANCELLED POST MARKET | 02461218 |
| TIVICAY | 25 MG | TABLET | VIIV HEALTHCARE ULC | CANCELLED POST MARKET | 02461226 |
2 · Same class — other molecules in ATC J05AJ
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Dolutegravir | TIVICAY | 4 | 2 | Yes |
| Raltegravir | ISENTRESS · ISENTRESS HD | 4 | 2 | Yes |
| Cabotegravir | APRETUDE · VOCABRIA | 2 | 2 | Yes |
| Elvitegravir | VITEKTA | 2 | 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 J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · Remdesivir · Valaciclovir · Valganciclovir | 143 | 55 |
| J05AR | Antivirals For Treatment Of Hiv Infections, Combinations · Atanazavir And Cobicistat · Darunavir And Cobicistat · Dolutegravir And Rilpivirine · Emtricitabine And Tenofovir Alafenamide · Emtricitabine, Tenofovir Alafenamide And Bictegravir · Emtricitabine, Tenofovir Alafenamide And Rilpivirine · Emtricitabine, Tenofovir Alafenamide, Darunavir And Cobicistat · Emtricitabine, Tenofovir Alafenamide, Elvitegravir And Cobicistat · Emtricitabine, Tenofovir Disoproxil And Efavirenz · Emtricitabine, Tenofovir Disoproxil And Rilpivirine · Emtricitabine, Tenofovir Disoproxil, Elvitegravir And Cobicistat · Lamivudine And Abacavir · Lamivudine And Dolutegravir · Lamivudine, Abacavir And Dolutegravir · Lamivudine, Tenofovir Disoproxil And Doravirine · Lopinavir And Ritonavir · Tenofovir Disoproxil And Emtricitabine · Zidovudine And Lamivudine · Zidovudine, Lamivudine And Abacavir · Zidovudine, Lamivudine And Nevirapine | 56 | 39 |
| J05AF | Abacavir · Adefovir Dipivoxil · Didanosine · Emtricitabine · Entecavir · Lamivudine · Stavudine · Telbivudine · Tenofovir Alafenamide · Tenofovir Disoproxil · Zalcitabine · Zidovudine | 71 | 39 |
| J05AH | Neuraminidase Inhibitors · Oseltamivir · Zanamivir | 33 | 16 |
| J05AX | Baloxavir Marboxil · Bulevirtide · Enfuvirtide · Fostemsavir · Inosine Pranobex · Lenacapavir · Letermovir · Maraviroc · Maribavir · Other Antivirals | 19 | 14 |
| J05AE | Amprenavir · Atazanavir · Darunavir · Fosamprenavir · Indinavir · Nelfinavir · Nirmatrelvir And Ritonavir · Ritonavir · Saquinavir · Tipranavir | 75 | 14 |
| J05AG | Delavirdine · Doravirine · Efavirenz · Etravirine · Nevirapine · Rilpivirine | 22 | 10 |
| J05AP | Asunaprevir · Boceprevir · Daclatasvir · Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir · Elbasvir And Grazoprevir · Glecaprevir And Pibrentasvir · Ombitasvir, Paritaprevir And Ritonavir · Ribavirin · Simeprevir · Sofosbuvir · Sofosbuvir And Ledipasvir · Sofosbuvir, Velpatasvir And Voxilaprevir · Telaprevir | 22 | 6 |
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 TIVICAY called?
The same molecule, Dolutegravir, 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 |
|---|---|---|
| Acriptega | Latin | South Africa |
| Dovato | Latin | Australia, Bahrain, Brazil |
| VOLUTRIP | Latin | South Africa |
| Aedatri | Latin | South Africa |
| Lanograv | Latin | South Africa |
| Milutin | Latin | South Africa |
| Reydin | Latin | South Africa |
| Triumeq | Latin | Australia, Bahrain |
| Altaeda | Latin | South Africa |
| Daliduo | Latin | South Africa |
| Dalimune | Latin | South Africa |
| Divtrida | Latin | South Africa |
| Dolutegravir Mylan | Latin | South Africa |
| Dotenal | Latin | South Africa |
| Gradovir | Latin | 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.