KETOTIFEN OPHTHALMIC SOLUTION 0.25 MG — DIN 02400871
KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG · STERIMAX INC · SOLUTION · wholesale supply in Canada
Health Canada status: DORMANT
What is KETOTIFEN OPHTHALMIC SOLUTION?
KETOTIFEN OPHTHALMIC SOLUTION 0.25 MG contains KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG. It is listed in the Health Canada Drug Product Database under DIN 02400871, held by STERIMAX INC, supplied as SOLUTION for OPHTHALMIC administration. Health Canada currently lists it as dormant, status dated 19-Aug-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 KETOTIFEN OPHTHALMIC SOLUTION used for?
Ketotifen Ophthalmic Solution is indicated for treatment of allergic conjunctivitis. It is used in adults and children older than 3 years of age, to treat itchy, watery, red or swollen eyes and/or eyelids, caused by seasonal allergies.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ketotifen cost around the world?
Ketotifen is listed on 9 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory); 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 |
|---|---|---|---|
| Saudi Arabia | public | 19 | 19 |
| Greece | producer price (ex-factory) | 8 | 8 |
| South Africa | single exit price | 3 | 5 |
| Romania | max producer price | 4 | 4 |
| Bahrain | retail (max) | 3 | 3 |
| United States | acquisition | 1 | 3 |
| Czechia | max producer price (ex-factory) | 1 | 2 |
| Iceland | max wholesale | 1 | 2 |
| United Arab Emirates | public | 1 | 1 |
47 pack listings across 41 brand entries and 8 price bases, refreshed 03 Sep 2026. Ranges span every Ketotifen 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 Ketotifen 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.
4 holders have a Canadian DIN containing Ketotifen, across 5 DINs, of which 2 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 |
|---|---|---|---|---|
| JAMP PHARMA CORPORATION | 2 | 1 | JAMP KETOTIFEN, JAMP KETOTIFEN OPHTHALMIC | Sourceable in Canada |
| LABORATOIRES THEA | 1 | 1 | ZADITOR | Sourceable in Canada |
| NOVARTIS PHARMACEUTICALS CANADA INC | 1 | 0 | ZADITOR | No marketed DIN |
| STERIMAX INC | 1 | 0 | KETOTIFEN OPHTHALMIC SOLUTION | 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 | 0.25 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | OPHTHALMIC |
| Pack configuration (monograph) | multi-dose white plastic bottles with controlled dropper tips containing 5 mL |
| Storage | Store between 4°C and 25°C. After opening the bottle, the eye drops can only be stored for 4 weeks. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Ketotifen |
|---|---|
| ATC code | S01GX08 |
| AHFS class | 52:02.00 |
| 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) | 02400871 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2400871 |
| Brand name | KETOTIFEN OPHTHALMIC SOLUTION |
| Generic / active ingredient | KETOTIFEN (KETOTIFEN FUMARATE) : 0.25 MG |
| Market authorization holder | STERIMAX INC |
| Health Canada schedule | Prescription |
| ATC code | S01GX08 |
| ATC anatomical main group | S — Sensory organs |
| ATC therapeutic subgroup | S01GX |
| Current status | DORMANT |
| Status date | 19-Aug-2021 |
| Original market date | 2013-03-07 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
One drop in the affected eye(s) every 8 to 12 hours. Use nasolacrimal occlusion for 1-2 minutes after administration to reduce systemic absorption.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to ketotifen or any ingredient in the formulation or component of the container.
Warnings and precautions
For topical use only. Not for injection/oral use. Contains benzalkonium chloride; remove soft contact lenses before use. May cause blurred vision or somnolence; caution when driving.
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 5 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP KETOTIFEN OPHTHALMIC | 0.25 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02542722 |
| ZADITOR | 0.25 MG | SOLUTION | LABORATOIRES THEA | MARKETED | 02242324 |
| JAMP KETOTIFEN | 0.025 % W/V | SOLUTION | JAMP PHARMA CORPORATION | APPROVED | 02489651 |
| ZADITOR | 0.25 MG | SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | 02279223 |
2 · Same class — other molecules in ATC S01GX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Olopatadine | ACT OLOPATADINE 0.1% · ACT OLOPATADINE 0.2% · APO-OLOPATADINE · JAMP-OLOPATADINE · +12 more | 17 | 9 | Yes |
| Ketotifen | JAMP KETOTIFEN · JAMP KETOTIFEN OPHTHALMIC · KETOTIFEN OPHTHALMIC SOLUTION · ZADITOR | 5 | 2 | Yes |
| Cromoglicic Acid | ALLERGAN EYE ITCH RELIEF · ANTI-ALLERGY EYE DROPS · CROMOLYN EYE DROPS · OPTICROM · +4 more | 8 | 1 | Yes |
| Lodoxamide | ALOMIDE | 1 | 1 | Yes |
| Nedocromil | ALOCRIL · MIREZE | 2 | 0 | Not in Canada |
| Levocabastine | LIVOSTIN EYE DROPS | 1 | 0 | Not in Canada |
| Emedastine | EMADINE | 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 S01G
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| S01GA | Naphazoline · Naphazoline, Combinations · Oxymetazoline · Phenylephrine · Phenylephrine, Combinations · +3 more | 75 | 17 |
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 KETOTIFEN OPHTHALMIC SOLUTION called?
The same molecule, Ketotifen, 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 |
|---|---|---|
| Zaditen | Latin | South Africa |
| Ketotifen | Latin | Iceland |
| KETOTIFEN AL | Latin | Czechia |
| Adco-Ketotifen | Latin | South Africa |
| Adco-Zetofen | Latin | South Africa |
| APIZAD | Latin | Bahrain |
| ASMAFORT | Latin | Bahrain |
| Fenobat | Latin | Saudi Arabia |
| HISTOFEN | Latin | Saudi Arabia |
| Keta | Latin | Saudi Arabia |
| PROFILAR | Latin | Bahrain |
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.