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

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CICLOPIROX

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 (D01A, D01AE) — coverage varies; not interchangeable

  • Terbinafine (Lamisil): general benefit
  • Clotrimazole (Clotrimaderm): general benefit, Not a benefit
  • Ketoconazole (Nizoral): general benefit, Not a benefit
  • Miconazole nitrate (Micatin): general benefit
  • Nystatin (Mycostatin): general benefit, Not a benefit
  • Betamethasone dipropionate + clotrimazole (Lotriderm Cream): not a benefit

Apo-Ciclopirox · DIN 02298953 · 8% W/W · Top Sol

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
Apo-Ciclopirox · DIN 02298953 Manufacturer: Apotex Inc.; listing date 2017-01-31 Health Canada: Marketed since 2008-04-18 · brand APO-CICLOPIROX · ATC D01AE14 CICLOPIROX · form Solution · route Topical · ingredients CICLOPIROX 8 %/W/W · company Apotex 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=78435 · Verify on the e-Formulary ↗ (DIN 02298953)

Source record
DIN 02298953: Apo-Ciclopirox Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 840408055; group id 817; item number 1996; lccId None; manufacturer id APX Source form: Top Sol; strength: 8% W/W Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $7.7433; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02298953 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78435
Interchangeable products
Penlac · DIN 02250535 · not recorded Taro-Ciclopirox · DIN 02353288 · not recorded
Shortage status: resolved shortage (ended 2019-05-22); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02298953
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Taro-Ciclopirox · DIN 02353288 · 8% W/W · Top Sol

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
Taro-Ciclopirox · DIN 02353288 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2017-03-28 Health Canada: Marketed since 2011-10-25 · brand TARO-CICLOPIROX · ATC D01AE14 CICLOPIROX · form Solution · route Topical · ingredients CICLOPIROX 8 %/W/W · company Taro pharmaceuticals 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=83849 · Verify on the e-Formulary ↗ (DIN 02353288)

Source record
DIN 02353288: Taro-Ciclopirox Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 840408055; group id 817; item number 1996; lccId None; manufacturer id TAR Source form: Top Sol; strength: 8% W/W Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $7.7433; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02353288 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=83849
Interchangeable products
Apo-Ciclopirox · DIN 02298953 · not recorded Penlac · DIN 02250535 · not recorded
Shortage status: active shortage (reported 2025-08-01, last updated 2026-07-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02353288
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Penlac · DIN 02250535 · 8% W/W · Top Sol

Off-Formulary Interchangeable, not an ODB benefitDormant since 2022-07-28 · 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
Penlac · DIN 02250535 Manufacturer: Valeant Canada Ltd.; listing date 2017-01-31 Health Canada: Dormant since 2022-07-28 · brand PENLAC · ATC D01AE14 CICLOPIROX · form Solution · route Topical · ingredients CICLOPIROX 8 %/W/W · company Bausch health, canada inc. · schedule Prescription
Check this DIN again · Health Canada product record

Penlac: 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=73535 · Verify on the e-Formulary ↗ (DIN 02250535)

Source record
DIN 02250535: Penlac Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 840408055; group id 817; item number 1996; lccId None; manufacturer id VAL Source form: Top Sol; strength: 8% W/W 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=02250535 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=73535
Interchangeable products
Apo-Ciclopirox · DIN 02298953 · not recorded Taro-Ciclopirox · DIN 02353288 · 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=02250535
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2022-07-28 — choose a marketed DIN from the same-category list.
Other drugs in the same formulary class (84:04:08 Fungicides) and how they are covered

Matched class: 84:04:08 Fungicides

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: MICONAZOLE NITRATE, TERBINAFINE HCL Some products covered without a code (check the product listing): CLOTRIMAZOLE, KETOCONAZOLE, NYSTATIN, TERCONAZOLE 84:04:08 Fungicides

TERBINAFINE HCL

· 1 products · General benefit · strengths: 1% · Cr

CLOTRIMAZOLE

· 7 products · General benefit (6), Listed, not a benefit (1) · strengths: 10mg/g, 500mg & 1%, 20mg/g · Cr, Tab & Cr, Vag Cr-App

KETOCONAZOLE

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

MICONAZOLE NITRATE

· 1 products · General benefit · strengths: 2% · Cr

NYSTATIN

· 7 products · Listed, not a benefit (3), General benefit (4) · strengths: 100000U/g, 25000U/g · Cr, Oint, Vag Cr

CLOTRIMAZOLE & BETAMETHASONE DIPROPIONATE

· 2 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 1% w/w & 0.05% w/w · Top Cr

TERCONAZOLE

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 0.4% · Vag Cr

FLUCONAZOLE

· 8 products · Limited Use, codes 235 · strengths: 150mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 84:04:08
Full class listing Related classes: 84:04:04 Antibiotics, 84:04:12 Parasiticides, 84:04:16 Other Anti-Infectives Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Please read this entire section carefully to fully understand the indication for this product. Topical treatment with APO-CICLOPIROX (Ciclopirox Topical Solution, 8% w/w) Nail Lacquer is indicated as part of a comprehensive nail management program in immunocompetent patients with mild to moderate onychomycosis (due to Trichophyton rubrum) of fingernails and toenails without lunula involvement. The comprehensive management program includes frequent removal of unattached, infected nails (e.g., monthly) by a health care professional with special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. APO-CICLOPIROX should therefore be used only under medical supervision. The safety and efficacy of daily use for longer than 48 weeks have not been established. (See PRECAUTIONS) Pivotal Clinical Trial Data Ciclopirox topical solution was used to treat onychomycosis of the great toenail (without lunula involvement) in two double-blind, placebo-controlled pivotal studies. Patients were treated once daily for up to 48 weeks in conjunction with monthly removal of the unattached, infecte… https://pdf.hres.ca/dpd_pm/00005895.PDF PM date: not printed or not captured Source product: APO-CICLOPIROX; DIN 02298953; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Taro-Ciclopirox · DIN 02353288 Shortage status: active shortage (reported 2025-08-01, last updated 2026-07-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02353288

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 Apo-Ciclopirox, Taro-Ciclopirox, Penlac: 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