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FEBUXOSTAT

All products: not a benefit

Other products in the same Health Canada class (M04AA) — coverage varies; not interchangeable

  • Allopurinol (Apo-Allopurinol Tablets): general benefit, Not a benefit

Mar-Febuxostat · DIN 02473607 · 80mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-19
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Febuxostat Brand(s): Generics of Uloric (see formulary OFIs) DOSAGE FORM/ STRENGTH: 80 mg Effective date: February 22, 2012, Criteria Updated: September 29, 2022 To lower serum uric acid levels, where recommended according to clinical guidelines, in patients with gout or hyperuricemia meeting at least one of the following: i. Patient has experienced an inadequate response to maximum tolerated doses of allopurinol; OR ii. Patient has experienced a hypersensitivity reaction to allopurinol; OR iii. Patient has documentation of an absolute contraindication to allopurinol. Patients who have experienced severe intolerances to allopurinol not meeting the above criteria will be considered on a case-by-case basis. Duration of approval: 1 year Renewal of funding will be considered for patients where there is objective evidence of clinical benefit from the use of febuxostat. Renewal approval period: 5 years 121 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 121, record 76, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)
1 brand, same coverage
Mar-Febuxostat · DIN 02473607 Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2019-07-31 Health Canada: Marketed since 2019-05-16 · brand MAR-FEBUXOSTAT · ATC M04AA03 FEBUXOSTAT · form Tablet · route Oral · ingredients FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80 MG · company Marcan pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

Mar-Febuxostat: Formulary list price $1.3515/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.3515 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

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=96300 · Verify on the e-Formulary ↗ (DIN 02473607)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02473607). DIN 02473607: Mar-Febuxostat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000658; group id 913; item number 2186; lccId None; manufacturer id MAR Source form: Tab; strength: 80mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.3515; ministry $1.3515 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02473607 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96300
Interchangeable products
Auro-Febuxostat · DIN 02533243 · $1.3515 Febuxostat · DIN 02539837 · $1.3515 Jamp-Febuxostat · DIN 02490870 · $1.3515 Teva-Febuxostat · DIN 02466198 · $1.3515 Uloric · DIN 02357380 · not recorded
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC 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: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

LEVODOPA & BENSERAZIDE

· 3 products · General benefit · strengths: 50mg & 12.5mg, 100mg & 25mg, 200mg & 50mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: 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 TEVA-FEBUXOSTAT (febuxostat) is indicated to lower serum uric acid levels in patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate. Geriatrics (> 65 years of age): No clinically significant differences in safety or efficacy were observed in geriatric patients compared to younger patients in clinical studies. Pediatrics (< 18 years of age): Safety and efficacy in pediatric patients have not been established. https://pdf.hres.ca/dpd_pm/00054874.PDF PM date: January 27, 2020 Source product: TEVA-FEBUXOSTAT; DIN 02466198; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Febuxostat (Generics of Uloric (see formulary OFIs))

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 121

Febuxostat Brand(s): Generics of Uloric (see formulary OFIs) DOSAGE FORM/ STRENGTH: 80 mg Effective date: February 22, 2012, Criteria Updated: September 29, 2022
To lower serum uric acid levels, where recommended according to clinical guidelines, in patients with gout or hyperuricemia meeting at least one of the following:
i. Patient has experienced an inadequate response to maximum tolerated doses of allopurinol; OR ii. Patient has experienced a hypersensitivity reaction to allopurinol; OR iii. Patient has documentation of an absolute contraindication to allopurinol.
Patients who have experienced severe intolerances to allopurinol not meeting the above criteria will be considered on a case-by-case basis.
Duration of approval: 1 year
Renewal of funding will be considered for patients where there is objective evidence of clinical benefit from the use of febuxostat.
Renewal approval period: 5 years
121

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.