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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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KETOTIFEN

All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules

Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

Other products in the same Health Canada class (S01GX) — coverage varies; not interchangeable

  • Cromoglycate (Cromolyn Eye Drops): general benefit, Not a benefit
  • Olopatadine (Pataday): not a benefit

Jamp Ketotifen Ophthalmic · DIN 02542722 · 0.25mg/mL · Oph Sol-5mL Pk

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Jamp Ketotifen Ophthalmic · DIN 02542722 Manufacturer: Jamp Pharma Corporation; listing date 2024-06-28 Health Canada: Marketed since 2025-02-21 · brand JAMP KETOTIFEN OPHTHALMIC · ATC S01GX08 KETOTIFEN · form Solution · route Ophthalmic · ingredients KETOTIFEN (KETOTIFEN FUMARATE) 0.25 MG/ML · company Jamp pharma corporation · schedule Prescription
Check this DIN again · Health Canada product record

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103126 · Verify on the e-Formulary ↗ (DIN 02542722)

Source record
DIN 02542722: Jamp Ketotifen Ophthalmic Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 523600136; group id 628; item number 1597; lccId None; manufacturer id JPC Source form: Oph Sol-5mL Pk; strength: 0.25mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $25.7800; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02542722 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103126
Interchangeable products
Ketotifen Ophthalmic Solution · DIN 02400871 · not recorded Zaditor · DIN 02242324 · not recorded
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02542722
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Zaditor · DIN 02242324 · 0.25mg/mL · Oph Sol-5mL Pk

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Zaditor · DIN 02242324 Manufacturer: Laboratoires Thea; listing date 2013-07-30 Health Canada: Marketed since 2012-08-10 · brand ZADITOR · ATC S01GX08 KETOTIFEN · form Solution · route Ophthalmic · ingredients KETOTIFEN (KETOTIFEN FUMARATE) 0.25 MG/ML · company Laboratoires thea · schedule Prescription
Check this DIN again · Health Canada product record

Zaditor: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=66035 · Verify on the e-Formulary ↗ (DIN 02242324)

Source record
DIN 02242324: Zaditor Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 523600136; group id 628; item number 1597; lccId None; manufacturer id LBT Source form: Oph Sol-5mL Pk; strength: 0.25mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02242324 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=66035
Interchangeable products
Jamp Ketotifen Ophthalmic · DIN 02542722 · not recorded Ketotifen Ophthalmic Solution · DIN 02400871 · not recorded
Shortage status: active shortage (reported 2026-07-14, estimated to end 2027-02-01, last updated 2026-08-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02242324
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Ketotifen Ophthalmic Solution · DIN 02400871 · 0.25mg/mL · Oph Sol-5mL Pk

Off-Formulary Interchangeable, not an ODB benefitDormant since 2021-08-19 · checked 2026-09-02 · What does dormant mean?
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Ketotifen Ophthalmic Solution · DIN 02400871 Manufacturer: Sterimax Inc.; listing date 2013-07-30 Health Canada: Dormant since 2021-08-19 · brand KETOTIFEN OPHTHALMIC SOLUTION · ATC S01GX08 KETOTIFEN · form Solution · route Ophthalmic · ingredients KETOTIFEN (KETOTIFEN FUMARATE) 0.25 MG/ML · company Sterimax inc · schedule Prescription
Check this DIN again · Health Canada product record

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88567 · Verify on the e-Formulary ↗ (DIN 02400871)

Source record
DIN 02400871: Ketotifen Ophthalmic Solution Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 523600136; group id 628; item number 1597; lccId None; manufacturer id STE Source form: Oph Sol-5mL Pk; strength: 0.25mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $21.1700; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02400871 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88567
Interchangeable products
Jamp Ketotifen Ophthalmic · DIN 02542722 · not recorded Zaditor · DIN 02242324 · not recorded
Shortage status: resolved shortage (ended 2019-06-27); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02400871
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2021-08-19 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (52:36 Other Eye, Ear, Nose and Throat Agents) and how they are covered

Matched class: 52:36 Other Eye, Ear, Nose and Throat Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: BETAXOLOL HCL, DICLOFENAC SODIUM, LEVOBUNOLOL HCL Some products covered without a code (check the product listing): ACETAZOLAMIDE, METHAZOLAMIDE, SODIUM CROMOGLYCATE, TIMOLOL MALEATE 52:36 Other Eye, Ear, Nose and Throat Agents

SODIUM CROMOGLYCATE

· 2 products · General benefit (1), Listed, not a benefit (1) · strengths: 2% · Oph Sol

OLOPATADINE HCL

· 14 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.2%, 0.1% · Oph Sol-2.5mL Pk, Oph Sol-5mL Pk

ACETAZOLAMIDE

· 2 products · General benefit (1), Listed, not a benefit (1) · strengths: 250mg · Tab

BETAXOLOL HCL

· 1 products · General benefit · strengths: 0.25% · Oph Susp

DICLOFENAC SODIUM

· 6 products · General benefit · strengths: 0.1% · Oph Sol

LEVOBUNOLOL HCL

· 1 products · General benefit · strengths: 0.5% · Oph Sol

METHAZOLAMIDE

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 50mg · Tab

TIMOLOL MALEATE

· 10 products · Listed, not a benefit (2), General benefit (8) · strengths: 0.25%, 0.5% · Oph Gellan Sol, Oph Sol

AFLIBERCEPT

· 6 products · Limited Use, codes 729, 730, 731 (4), Limited Use, codes 694, 695 (2) · strengths: 2mg/0.05mL, 8mg/0.07mL · Inj Sol-0.05mL Pref Syr (Preservative-Free), Inj Sol-0.07mL Pref Syr, Inj Sol-0.07mL Vial Pk, Sol for Intravitreal Inj-0.05mL Vial Pk

BIMATOPROST

· 8 products · Listed, not a benefit (1), Limited Use, codes 171, 172, 387 (7) · strengths: 0.03%, 0.01% · Oph Sol, Oph Sol-5mL Pk, Oph Sol-7.5mL Pk

BRIMONIDINE

· 7 products · Limited Use, codes 171, 172, 387 · strengths: 0.15%, 0.2% · Oph Sol

BRIMONIDINE TARTRATE & TIMOLOL MALEATE

· 3 products · Limited Use, codes 310, 393 · strengths: 0.2% & 0.5% · Oph Sol-10mL Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 52:36 and 20 more
Full class listing Related classes: 52:04 Anti-Infectives, 52:08 Anti-Inflammatory Agents, 52:16 Local Anesthetics, 52:20 Miotics, 52:24 Mydriatics, 52:32 Vasoconstrictors Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: allergic conjunctivitis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. OLOPATADINE HCL · Off-Formulary Interchangeable, not an ODB benefit INDICATIONS AND CLINICAL USE PATANOL® (olopatadine hydrochloride ophthalmic solution) is indicated for the treatment of allergic conjunctivitis. PM: https://pdf.hres.ca/dpd_pm/00044108.PDF; date March 2, 2018; DIN 02233143; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS ZADITOR* (ketotifen fumarate ophthalmic solution) is indicated for: • treatment of allergic conjunctivitis. 1.1 Pediatrics • Pediatrics (> 3 years of age): ZADITOR* is indicated for use in pediatric patients over the age of 3 years. 1.2 Geriatrics • Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use https://pdf.hres.ca/dpd_pm/00076212.PDF PM date: February 23, 2012 Source product: ZADITOR; DIN 02242324; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Zaditor · DIN 02242324 Shortage status: active shortage (reported 2026-07-14, estimated to end 2027-02-01, last updated 2026-08-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02242324

Check this DIN again
Health Canada: dormant products
Health Canada defines dormant products as: “products that were previously marketed in Canada but for which the manufacturer has suspended sale for period of at least 12 months.” (canada.ca, Sep 10, 2026 ↗)

Other review policies

For Jamp Ketotifen Ophthalmic, Zaditor, Ketotifen Ophthalmic Solution: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026