BIKTARVY 50 MG — DIN 02478579
BICTEGRAVIR (BICTEGRAVIR SODIUM) : 50 MG EMTRICITABINE : 200 MG TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) : 25 MG · GILEAD SCIENCES CANADA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is BIKTARVY?
BIKTARVY 50 MG contains BICTEGRAVIR (BICTEGRAVIR SODIUM) : 50 MG EMTRICITABINE : 200 MG TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02478579, held by GILEAD SCIENCES CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Aug-2018. 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 BIKTARVY used for?
BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg with no known substitution associated with resistance to bictegravir or tenofovir.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Emtricitabine, Tenofovir Alafenamide And Bictegravir 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 Emtricitabine, Tenofovir Alafenamide And Bictegravir — 2 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 |
|---|---|---|---|---|
| GILEAD SCIENCES CANADA INC | 2 | 2 | BIKTARVY | 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) | Each bottle contains 7 or 30 tablets. There are 4 blister cards containing 7 tablets and 1 card containing 2 tablets placed inside a paperboard carton for a total of 30 tablets per pack. |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Emtricitabine, Tenofovir Alafenamide And Bictegravir |
|---|---|
| ATC code | J05AR20 |
| AHFS class | 24:06.05 |
| 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) | 02478579 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2478579 |
| Brand name | BIKTARVY |
| Generic / active ingredient | BICTEGRAVIR (BICTEGRAVIR SODIUM) : 50 MG EMTRICITABINE : 200 MG TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE) : 25 MG |
| Market authorization holder | GILEAD SCIENCES CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | J05AR20 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AR |
| Current status | MARKETED |
| Status date | 08-Aug-2018 |
| Original market date | 2018-08-14 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
2 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| BIKTARVY | 10MG | Capsule | GILEAD SCIENCES CANADA INC | MARKETED | 02561492 |
2 · Same class — other molecules in ATC J05AR
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Tenofovir Disoproxil And Emtricitabine | AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE · APO-EMTRICITABINE-TENOFOVIR · AURO-EMTRICITABINE-TENOFOVIR · JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE · +6 more | 10 | 9 | Yes |
| Emtricitabine, Tenofovir Disoproxil And Efavirenz | APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR · ATRIPLA · AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR · JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE · +5 more | 9 | 5 | Yes |
| Lamivudine And Abacavir | APO-ABACAVIR-LAMIVUDINE · APO-ABACAVIR-LAMIVUDINE TABLETS · AURO-ABACAVIR/LAMIVUDINE · JAMP ABACAVIR / LAMIVUDINE · +5 more | 9 | 4 | Yes |
| Zidovudine And Lamivudine | APO-LAMIVUDINE-ZIDOVUDINE · AURO-LAMIVUDINE/ZIDOVUDINE · COMBIVIR · JAMP LAMIVUDINE / ZIDOVUDINE · +1 more | 5 | 3 | Yes |
| Lopinavir And Ritonavir | KALETRA | 4 | 3 | Yes |
| Emtricitabine, Tenofovir Alafenamide And Bictegravir | BIKTARVY | 2 | 2 | Yes |
| Emtricitabine And Tenofovir Alafenamide | DESCOVY | 2 | 2 | Yes |
| Emtricitabine, Tenofovir Alafenamide And Rilpivirine | ODEFSEY | 1 | 1 | Yes |
| Darunavir And Cobicistat | PREZCOBIX | 1 | 1 | Yes |
| Emtricitabine, Tenofovir Alafenamide, Elvitegravir And Cobicistat | GENVOYA | 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 J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · +3 more | 143 | 55 |
| J05AF | Abacavir · Adefovir Dipivoxil · Didanosine · Emtricitabine · Entecavir · +7 more | 71 | 39 |
| J05AH | Neuraminidase Inhibitors · Oseltamivir · Zanamivir | 33 | 16 |
| J05AX | Baloxavir Marboxil · Bulevirtide · Enfuvirtide · Fostemsavir · Inosine Pranobex · +5 more | 19 | 14 |
| J05AE | Amprenavir · Atazanavir · Darunavir · Fosamprenavir · Indinavir · +5 more | 75 | 14 |
| J05AG | Delavirdine · Doravirine · Efavirenz · Etravirine · Nevirapine · +1 more | 22 | 10 |
| J05AJ | Cabotegravir · Dolutegravir · Elvitegravir · Raltegravir | 12 | 6 |
| J05AP | Asunaprevir · Boceprevir · Daclatasvir · Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir · Elbasvir And Grazoprevir · +8 more | 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.
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.