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

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TERIFLUNOMIDE

All products: Limited Use (codes 647)

Other products in the same Health Canada class (L04A, L04AK) — coverage varies; not interchangeable

  • Leflunomide (Arava): general benefit
  • Azathioprine (Imuran): general benefit
  • Cyclosporine (Neoral): general benefit
  • Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
  • Mycophenolate (Myfortic): general benefit
  • Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634

15 more in the class list below

Jamp Teriflunomide · DIN 02504170 · 14mg · tablet

Limited Use — Reason for Use code 647 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 647 required
Write on scriptLU code 647 (patient must meet the criteria below)
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

Ontario Limited Use criteria — code 647
Reason for Use code 647 For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older; AND 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following: - 2 or more attacks (Note 1) and clinical evidence of 2 or more lesions (Note 2); OR - 2 or more attacks and clinical evidence of 1 lesion with clear historical evidence of a prior attack involving a lesion in a different location; Note 1: If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: - Additional clinical attack - Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR a new T2 or enhancing MRI lesion compared to a baseline scan (without regard to timing of baseline scan) - Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands Note 2: If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: - additional clinical attack implicating different CNS site - 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 4. Patient has an Expanded Disability Status Scale (EDSS) score less than 6.0 before start of therapy; AND 5. Teriflunomide is used as monotherapy; AND 6. The drug request is from a neurologist experienced in the management of RRMS. Exclusion Criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0. LU Authorization Period: 1 year Renewal Criteria: Teriflunomide may be continued for the treatment of RRMS for patients who have not experienced a suboptimal response with teriflunomide monotherapy and who have an EDSS score less than 7.0. Patients who continue to experience clinical attacks or increased lesions or worsening EDSS should be evaluated for appropriateness of therapy and consideration of other treatment options available on the ODB formulary or through the Exceptional Access Program. Renewal duration: 1 year Recommended Dose: 14mg once daily Refer to the product monograph for prescribing information. Exceptional Access criteria on record are for Brand(s): Aubagio; DOSAGE FORM/ STRENGTH: 14 mg tablet — not this product; no criteria on record for this product in this block. 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 Teriflunomide Brand(s): Aubagio DOSAGE FORM/ STRENGTH: 14 mg tablet Moved to ODB formulary effective May 31, 2023 This drug is available on the ODB formulary as a Limited Use Benefit. Please refer to the formulary for the updated ODB funding criteria. 241 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 241, record 142, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Jamp Teriflunomide · DIN 02504170 Manufacturer: Jamp Pharma Corporation; listing date 2022-07-29 Health Canada: Marketed since 2022-05-16 · brand JAMP TERIFLUNOMIDE · ATC L04AK02 TERIFLUNOMIDE · form Tablet · route Oral · ingredients TERIFLUNOMIDE 14 MG · company Jamp pharma corporation · schedule Prescription
Check this DIN again · Health Canada product record

Jamp Teriflunomide: Formulary list price $14.9300/unit (unit not stated in source; not the patient's cost)

Ministry pays: $14.9300 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=99361 · Verify on the e-Formulary ↗ (DIN 02504170)

Source record
DIN 02504170: Jamp Teriflunomide Raw flags: sec12=Y, sec3=Y Item: 920000701; group id 967; item number 2297; lccId 00370; manufacturer id JPC Source form: Tab; strength: 14mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $14.9300; ministry $14.9300 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02504170 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99361
Interchangeable products
Ach-Teriflunomide · DIN 02502933 · $14.9300 Apo-Teriflunomide · DIN 02500639 · $14.9300 Aubagio · DIN 02416328 · not recorded M-Teriflunomide · DIN 02523833 · $14.9300 Mar-Teriflunomide · DIN 02500469 · $14.9300 Nat-Teriflunomide · DIN 02500310 · $14.9300 PMS-Teriflunomide · DIN 02500434 · $14.9300 Sandoz Teriflunomide · DIN 02505843 · $14.9300 Teva-Teriflunomide · DIN 02501090 · $14.9300
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

LEFLUNOMIDE

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

AZATHIOPRINE

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

CYCLOSPORINE

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

MYCOPHENOLATE MOFETIL

· 16 products · General benefit (14), Limited Use, codes 556 (2) · strengths: 250mg, 200mg/mL, 500mg · Cap, Pd for Oral Susp-175mL Pk, Tab

MYCOPHENOLATE SODIUM

· 8 products · General benefit · strengths: 180mg, 360mg · Ent Tab

LENALIDOMIDE

· 42 products · Limited Use, codes 630, 631, 632, 659, 741 · strengths: 2.5mg, 15mg, 20mg, 25mg, 5mg, 10mg · Cap

SIROLIMUS

· 2 products · Limited Use, codes 392 · strengths: 1mg/mL, 1mg · O/L, Tab

TACROLIMUS

· 20 products · Limited Use, codes 173 (10), Limited Use, codes 410 (8), Limited Use, codes 383 (2) · strengths: 5mg/mL, 0.5mg, 1mg, 5mg, 3mg, 0.03%, 0.1% · Amp, Cap, ER Cap, Oint

USTEKINUMAB

· 14 products · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (2), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (2) · strengths: 45mg/0.5mL, 90mg/1.0mL, 90mg/mL, 130mg/26mL, 5mg/mL · Inj Sol-0.5mL Pref Autoinj (Preservative-Free), Inj Sol-0.5mL Pref Syr Pk, Inj Sol-0.5mL Pref Syr Pk (Preservative-Free), Inj Sol-0.5mL Vial Pk, Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr Pk, Inj Sol-26mL Vial Pk, Inj Sol-26mL Vial Pk (Preservative-Free), Inj Sol-Vial Pk (Preservative-Free)

FINGOLIMOD

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg · Cap

PIRFENIDONE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 267mg · Cap

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab 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.
Other drugs whose Health Canada label lists a similar indication: relapsing remitting multiple sclerosis
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. DIMETHYL FUMARATE · Off-Formulary Interchangeable, not an ODB benefit Indications TECFIDERA (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability. PM: https://pdf.hres.ca/dpd_pm/00085501.PDF; date 2026-07-23; DIN 02404508; 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 NAT-TERIFLUNOMIDE (teriflunomide) is indicated for: • monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. NAT-TERIFLUNOMIDE should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of teriflunomide tablets have not been established in pediatric patients and NAT-TERIFLUNOMIDE is not recommended in this patient population. 1.2 Geriatrics Clinical studies of teriflunomide did not include patients over 65 years old. NAT-TERIFLUNOMIDE should be used with caution in patients aged 65 years and over. Physicians who choose to treat geriatric patients should consider that treatment with NAT-TERIFLUNOMIDE in the context of a greater frequency of other concomitant diseases and concomitant drug therapy warrants caution and may necessitate additional or more frequent monitoring (see 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.4 Geriatrics). https://pdf.hres.ca/dpd_pm/00073931.PDF PM date: June 16, 2020 Source product: NAT-TERIFLUNOMIDE; DIN 02500310; 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

Teriflunomide (Aubagio)

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 241

Teriflunomide Brand(s): Aubagio DOSAGE FORM/ STRENGTH: 14 mg tablet Moved to ODB formulary effective May 31, 2023
This drug is available on the ODB formulary as a Limited Use Benefit.
Please refer to the formulary for the updated ODB funding criteria.
241

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