DARUNAVIR 800 MG — DIN 02521350
DARUNAVIR : 800 MG · JAMP PHARMA CORPORATION · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is DARUNAVIR?
DARUNAVIR 800 MG contains DARUNAVIR : 800 MG. It is listed in the Health Canada Drug Product Database under DIN 02521350, held by JAMP PHARMA CORPORATION, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 25-Apr-2022. 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 DARUNAVIR used for?
Darunavir (darunavir), co-administered with 100 mg ritonavir, and with other antiretroviralagents, is indicated for the treatment of HIV-1 infection in patients > 40 kg. For a description of the clinical data in support of this indication, refer to 14 CLINICAL TRIALS.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Darunavir cost around the world?
Darunavir 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; Belgium publishes a public; 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 |
|---|---|---|---|---|
| United States | acquisition | 2 | 22 | USD███.██ |
| Sweden | AIP (pharmacy purchase price) | 8 | 17 | SEK███.██ |
| Greece | producer price (ex-factory) | 14 | 14 | EUR███.██ |
| Romania | max producer price | 11 | 14 | RON███.██ |
| South Africa | single exit price | 14 | 14 | ZAR███.██ |
| Italy | ex-factory (classe H) | 7 | 13 | EUR███.██ |
| Saudi Arabia | public | 5 | 7 | SAR███.██ |
| Australia | ex-manufacturer | 4 | 6 | AUD███.██ |
| Belgium | public | 3 | 3 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 2 | NOK███.██ |
| Slovakia | categorised final price | 2 | 2 | EUR███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 1 | 1 | BRL███.██ |
| Czechia | max producer price (ex-factory) | 1 | 1 | CZK███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
| Luxembourg | reimbursement | 1 | 1 | EUR███.██ |
118 pack listings across 75 brand entries and 14 price bases, refreshed 08 Sep 2026. Ranges span every Darunavir 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 Darunavir 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.
10 holders have a Canadian DIN containing Darunavir, across 37 DINs, of which 5 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 |
|---|---|---|---|---|
| AURO PHARMA INC | 3 | 2 | AURO-DARUNAVIR | Sourceable in Canada |
| APOTEX INC | 2 | 2 | APO-DARUNAVIR | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 3 | 1 | DARUNAVIR | Sourceable in Canada |
| JANSSEN INC | 7 | 0 | PREZISTA | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 6 | 0 | MYLAN-DARUNAVIR | No marketed DIN |
| PATRIOT A DIVISION OF JANSSEN INC | 5 | 0 | PAT-DARUNAVIR | No marketed DIN |
| MANTRA PHARMA INC | 3 | 0 | M-DARUNAVIR | No marketed DIN |
| MARCAN PHARMACEUTICALS INC | 3 | 0 | MAR-DARUNAVIR | No marketed DIN |
| NATCO PHARMA (CANADA) INC | 3 | 0 | NAT-DARUNAVIR | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 2 | 0 | SANDOZ DARUNAVIR | 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 | 800 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Darunavir Tablets 400 mg and 800 mg are available in HDPE bottles of 30 tablets. Darunavir Tablets 600 mg is available in HDPE bottles of 30 tablets and 60 tablets. |
| Storage | null |
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 | Darunavir |
|---|---|
| ATC code | J05AE10 |
| AHFS class | 08:18.08.08 |
| 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) | 02521350 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2521350 |
| Brand name | DARUNAVIR |
| Generic / active ingredient | DARUNAVIR : 800 MG |
| Market authorization holder | JAMP PHARMA CORPORATION |
| Health Canada schedule | Prescription |
| ATC code | J05AE10 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AE |
| Current status | MARKETED |
| Status date | 25-Apr-2022 |
| Original market date | 2022-04-25 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 37 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-DARUNAVIR | 800 MG | TABLET | APOTEX INC | MARKETED | 02487268 |
| APO-DARUNAVIR | 600 MG | TABLET | APOTEX INC | MARKETED | 02487241 |
| AURO-DARUNAVIR | 800 MG | TABLET | AURO PHARMA INC | MARKETED | 02486148 |
| AURO-DARUNAVIR | 600 MG | TABLET | AURO PHARMA INC | MARKETED | 02486121 |
| AURO-DARUNAVIR | 400 MG | TABLET | AURO PHARMA INC | APPROVED | 02486113 |
| DARUNAVIR | 400 MG | TABLET | JAMP PHARMA CORPORATION | APPROVED | 02521334 |
| DARUNAVIR | 600 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | 02521342 |
| M-DARUNAVIR | 600 MG | TABLET | MANTRA PHARMA INC | CANCELLED POST MARKET | 02522284 |
| M-DARUNAVIR | 400 MG | TABLET | MANTRA PHARMA INC | CANCELLED PRE MARKET | 02522276 |
| M-DARUNAVIR | 800 MG | TABLET | MANTRA PHARMA INC | CANCELLED POST MARKET | 02522292 |
2 · Same class — other molecules in ATC J05AE
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Atazanavir | APO-ATAZANAVIR · JAMP ATAZANAVIR · MYLAN-ATAZANAVIR · REYATAZ · +1 more | 16 | 6 | Yes |
| Darunavir | APO-DARUNAVIR · AURO-DARUNAVIR · DARUNAVIR · M-DARUNAVIR · +6 more | 37 | 5 | Yes |
| Ritonavir | AURO-RITONAVIR · NORVIR · NORVIR SEC | 5 | 2 | Yes |
| Nirmatrelvir And Ritonavir | PAXLOVID | 2 | 1 | Yes |
| Amprenavir | AGENERASE | 3 | 0 | Not in Canada |
| Indinavir | CRIXIVAN | 3 | 0 | Not in Canada |
| Nelfinavir | VIRACEPT · VIRACEPT -250MG · VIRACEPT -50MG | 3 | 0 | Not in Canada |
| Saquinavir | FORTOVASE ROCHE · INVIRASE · INVIRASE - CAP 200MG | 3 | 0 | Not in Canada |
| Fosamprenavir | TELZIR | 2 | 0 | Not in Canada |
| Tipranavir | APTIVUS | 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 J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · +3 more | 143 | 55 |
| J05AR | Antivirals For Treatment Of Hiv Infections, Combinations · Atanazavir And Cobicistat · Darunavir And Cobicistat · Dolutegravir And Rilpivirine · Emtricitabine And Tenofovir Alafenamide · +16 more | 56 | 39 |
| 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 |
| 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.
What else is DARUNAVIR called?
The same molecule, Darunavir, 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 |
|---|---|---|
| Darunavir Krka | Latin | Norway, Sweden |
| Prezista | Latin | Australia, Brazil, South Africa |
| PREZISTA® | Latin | Sweden |
| Symtuza | Latin | Australia, Czechia, Iceland |
| Darista | Latin | Saudi Arabia |
| Darunavir Accord | Latin | Sweden |
| Darunavir Amarox | Latin | Sweden |
| Darunavir Glenmark | Latin | Sweden |
| Darunavir Juno | Latin | Australia |
| Darunavir Medical Valley | Latin | Sweden |
| Darunavir STADA | Latin | Sweden |
| Darunavir Viatris | Latin | Sweden |
| Dunarez | Latin | Saudi Arabia |
| Prezcobix | Latin | Australia |
| Zadurna | 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.