NAT-ERLOTINIB 25 MG — DIN 02483912
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) : 25 MG · NATCO PHARMA (CANADA) INC · TABLET · wholesale supply in Canada
Health Canada status: DORMANT
What is NAT-ERLOTINIB?
NAT-ERLOTINIB 25 MG contains ERLOTINIB (ERLOTINIB HYDROCHLORIDE) : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02483912, held by NATCO PHARMA (CANADA) INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 01-May-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is NAT-ERLOTINIB used for?
Monotherapy for locally advanced or metastatic NSCLC after failure of prior chemotherapy, or as first-line/maintenance treatment in patients with EGFR activating mutations.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Erlotinib cost around the world?
Erlotinib 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; Bahrain publishes a retail (max); Greece publishes a producer price (ex-factory). 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 | 2 | 18 | AUD███.██ |
| Saudi Arabia | public | 10 | 17 | SAR███.██ |
| Hungary | producer price (ex-factory) | 14 | 14 | HUF███.██ |
| Romania | max producer price | 6 | 10 | RON███.██ |
| Sweden | AIP (pharmacy purchase price) | 3 | 9 | SEK███.██ |
| Italy | ex-factory (classe H) | 4 | 8 | EUR███.██ |
| Greece | producer price (ex-factory) | 7 | 7 | EUR███.██ |
| Slovakia | categorised final price | 7 | 7 | EUR███.██ |
| South Africa | single exit price | 7 | 7 | ZAR███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| Iceland | max wholesale | 2 | 3 | ISK███.██ |
| Bahrain | retail (max) | 1 | 2 | BHD███.██ |
105 pack listings across 66 brand entries and 11 price bases, refreshed 08 Sep 2026. Ranges span every Erlotinib 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 Erlotinib 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.
5 holders have a Canadian DIN containing Erlotinib, across 14 DINs, of which 7 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 |
|---|---|---|---|---|
| APOTEX INC | 3 | 3 | APO-ERLOTINIB | Sourceable in Canada |
| TEVA CANADA LIMITED | 3 | 3 | TEVA-ERLOTINIB | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 1 | PMS-ERLOTINIB | Sourceable in Canada |
| HOFFMANN-LA ROCHE LIMITED | 3 | 0 | TARCEVA | No marketed DIN |
| NATCO PHARMA (CANADA) INC | 3 | 0 | NAT-ERLOTINIB | 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 | 25 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text (refers to DOSAGE FORMS, COMPOSITION AND PACKAGING section). |
| Storage | Not explicitly detailed in the provided text (refers to STORAGE AND STABILITY section). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Erlotinib |
|---|---|
| ATC code | L01EB02 |
| AHFS class | 84:80.00 |
| 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) | 02483912 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2483912 |
| Brand name | NAT-ERLOTINIB |
| Generic / active ingredient | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) : 25 MG |
| Market authorization holder | NATCO PHARMA (CANADA) INC |
| Health Canada schedule | Prescription |
| ATC code | L01EB02 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01EB |
| Current status | DORMANT |
| Status date | 01-May-2021 |
| Original market date | 2019-07-26 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Administered orally once daily. EGFR mutation-positive status must be confirmed prior to starting first-line or maintenance therapy. Dose reduction/interruption may be needed for toxicity.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Severe hypersensitivity to erlotinib or to any component of NAT-ERLOTINIB.
Warnings and precautions
Serious/fatal risks: Hepatotoxicity, Gastrointestinal Perforation, Interstitial Lung Disease (ILD), and severe bullous/exfoliative skin disorders. Monitor for dehydration and ocular disorders.
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
7 of 14 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-ERLOTINIB | 100 MG | TABLET | APOTEX INC | MARKETED | 02461870 |
| APO-ERLOTINIB | 150 MG | TABLET | APOTEX INC | MARKETED | 02461889 |
| APO-ERLOTINIB | 25 MG | TABLET | APOTEX INC | MARKETED | 02461862 |
| PMS-ERLOTINIB | 150 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02454394 |
| TEVA-ERLOTINIB | 25 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02377691 |
| TEVA-ERLOTINIB | 100 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02377705 |
| TEVA-ERLOTINIB | 150 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02377713 |
| NAT-ERLOTINIB | 150 MG | TABLET | NATCO PHARMA (CANADA) INC | DORMANT | 02483939 |
| NAT-ERLOTINIB | 100 MG | TABLET | NATCO PHARMA (CANADA) INC | DORMANT | 02483920 |
| PMS-ERLOTINIB | 100 MG | TABLET | PHARMASCIENCE INC | DORMANT | 02454386 |
2 · Same class — other molecules in ATC L01EB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Afatinib | GIOTRIF · MAR-AFATINIB · SANDOZ AFATINIB · TEVA-AFATINIB | 12 | 9 | Yes |
| Erlotinib | APO-ERLOTINIB · NAT-ERLOTINIB · PMS-ERLOTINIB · TARCEVA · +1 more | 14 | 7 | Yes |
| Gefitinib | APO-GEFITINIB · AURO-GEFITINIB · EUGIA-GEFITINIB · IRESSA · +3 more | 7 | 3 | Yes |
| Lazertinib | LAZCLUZE | 2 | 2 | Yes |
| Osimertinib | TAGRISSO | 2 | 2 | Yes |
| Dacomitinib | VIZIMPRO | 3 | 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 L01E
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01EX | Avapritinib · Cabozantinib · Capivasertib · Capmatinib · Entrectinib · +17 more | 80 | 64 |
| L01EA | Asciminib · Bosutinib · Dasatinib · Imatinib · Nilotinib · +1 more | 73 | 57 |
| L01EF | Abemaciclib · Palbociclib · Ribociclib | 17 | 14 |
| L01ED | Alectinib · Brigatinib · Ceritinib · Crizotinib · Lorlatinib | 10 | 10 |
| L01EJ | Fedratinib · Momelotinib · Ruxolitinib | 8 | 8 |
| L01EE | Binimetinib · Cobimetinib · Selumetinib · Trametinib | 8 | 7 |
| L01EN | Erdafitinib · Infigratinib · Pemigatinib | 11 | 6 |
| L01EC | Dabrafenib · Encorafenib · Vemurafenib | 5 | 5 |
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 NAT-ERLOTINIB called?
The same molecule, Erlotinib, 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 |
|---|---|---|
| ERLOTINIB ARX | Latin | Australia |
| Erlotinib Sandoz | Latin | Australia |
| Tarceva | Latin | Iceland, Sweden |
| CALIVERA | Latin | Saudi Arabia |
| Tyrox | Latin | Saudi Arabia |
| Erlotinib EPC | Latin | Saudi Arabia |
| Erlotinib SPC | Latin | Saudi Arabia |
| Erlotinib STADA | Latin | Sweden |
| Erlotinib WH | Latin | Iceland |
| Erloz | Latin | Saudi Arabia |
| PULECTUS | Latin | Bahrain |
| Erlotinib Krka | Latin | Sweden |
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?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.