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

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VARDENAFIL HCL

All products: not a benefit

Other products in the same Health Canada class (G04BE) — coverage varies; not interchangeable

  • Tadalafil (Cialis): not a benefit

Vardenafil · DIN 02520400 · 20mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-19
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Vardenafil · DIN 02520400 Manufacturer: Sanis Health Inc.; listing date 2021-12-17 Health Canada: Marketed since 2022-03-25 · brand VARDENAFIL · ATC G04BE09 VARDENAFIL · form Tablet · route Oral · ingredients VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE) 20 MG · company Sanis health 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=100960 · Verify on the e-Formulary ↗ (DIN 02520400)

Source record
DIN 02520400: Vardenafil Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 241200109; group id 372; item number 0887; lccId None; manufacturer id SAI Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $11.6811; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02520400 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100960
Interchangeable products
Apo-Vardenafil · DIN 02471663 · not recorded Jamp-Vardenafil IR · DIN 02475693 · not recorded Levitra · DIN 02250489 · not recorded Mylan-Vardenafil · DIN 02464233 · not recorded
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (24:12 Vasodilating Drugs) and how they are covered

Matched class: 24:12 Vasodilating Drugs

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Some products covered without a code (check the product listing): ISOSORBIDE DINITRATE, NITROGLYCERIN 24:12 Vasodilating Drugs

TADALAFIL

· 73 products · Off-Formulary Interchangeable, not an ODB benefit (72), Off-Formulary Interchangeable, not an ODB benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1) · strengths: 2.5mg, 5mg, 10mg, 20mg · Tab

ISOSORBIDE DINITRATE

· 6 products · General benefit (3), Listed, not a benefit (3) · strengths: 5mg, 10mg, 30mg · SL Tab, Tab

NITROGLYCERIN

· 20 products · General benefit (13), Temporary benefit (2), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 0.4mg/Hr/20 Sq Cm, 0.6mg/Hr/30 Sq Cm, 0.4mg/Hr/14 Sq Cm, 0.6mg/Hr/21 Sq Cm, 0.3mg, 0.6mg, 0.4mg/Metered Dose, 0.2mg/Hr, 0.4mg/Hr, 0.6mg/Hr, 0.8mg/Hr · Patch, SL Tab, Sp-180 Dose Pk, Sp-75 Dose Pk, Spray-200 Dose Pk, Transdermal Patch

DIPYRIDAMOLE & ACETYLSALICYLIC ACID

· 2 products · Listed, not a benefit (1), Limited Use, codes 349 (1) · strengths: 200mg/25mg · Cap

NIMODIPINE

· 1 products · Limited Use, codes 42, 43 · strengths: 30mg · Tab

VERICIGUAT

· 3 products · Limited Use, codes 685 · strengths: 2.5mg, 5mg, 10mg · Tab

AMBRISENTAN

· 7 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 10mg · Tab

BETAHISTINE DIHYDROCHLORIDE

· 24 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 8mg, 16mg, 24mg · Tab

BOSENTAN MONOHYDRATE

· 14 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 62.5mg, 125mg · Tab

DIPYRIDAMOLE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 25mg, 50mg, 75mg · Tab

ISOSORBIDE-5-MONONITRATE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 60mg · ER Tab

RIOCIGUAT

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg, 1.5mg, 1mg, 2.5mg, 2mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:12
Full class listing Related classes: 24:04 Cardiac Drugs, 24:06 Antilipemic Drugs, 24:08 Hypotensive Drugs (For Diuretics See 40:28), 24:32 Renin-Angiotensin Aldosterone Inhibitors Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: erectile dysfunction
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. TADALAFIL · Off-Formulary Interchangeable, not an ODB benefit (72), Off-Formulary Interchangeable, not an ODB benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1) INDICATIONS AND CLINICAL USE CIALIS (tadalafil) is indicated for the treatment of erectile dysfunction (ED) in men. PM: https://pdf.hres.ca/dpd_pm/00037181.PDF; date not captured; DIN 02248088; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE MYLAN-VARDENAFIL (vardenafil tablets) is indicated for:  Treatment of erectile dysfunction (difficulties or the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). Special Populations Pregnant and Nursing Women: MYLAN-VARDENAFIL is not indicated for use in women. There are no trials of vardenafil tablets in pregnant women. Pediatrics (< 18 years of age): MYLAN-VARDENAFIL is not indicated for use in individuals less than 18 years old. Geriatrics (≥ 65 years of age): A starting dose of 5 mg MYLAN-VARDENAFIL should be considered in patients 65 years and older. On average, elderly males (65 years and over) had a 52% higher vardenafil AUC than younger males (18-45 years); however, this difference was not statistically significant. (See ACTION AND CLINICAL PHARMACOLOGY and DETAILED PHARMACOLOGY.) Page 3 of 58 https://pdf.hres.ca/dpd_pm/00057041.PDF PM date: June 22, 2020 Source product: MYLAN-VARDENAFIL; DIN 02464209; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Vardenafil: 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