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

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ATOMOXETINE HCL

All products: not a benefit

Auro-Atomoxetine · DIN 02471558 · 100mg · capsule

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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.
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
Auro-Atomoxetine · DIN 02471558 Manufacturer: Auro Pharma Inc.; listing date 2019-03-28 Health Canada: Marketed since 2019-02-04 · brand AURO-ATOMOXETINE · ATC N06BA09 ATOMOXETINE · form Capsule · route Oral · ingredients ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 100 MG · company Auro pharma 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=96070 · Verify on the e-Formulary ↗ (DIN 02471558)

Source record
DIN 02471558: Auro-Atomoxetine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 289200039; group id 535; item number 1451; lccId None; manufacturer id AUR Source form: Cap; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $4.3520; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02471558 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96070
Interchangeable products
Apo-Atomoxetine · DIN 02318083 · not recorded Atomoxetine · DIN 02467828 · not recorded Jamp Atomoxetine · DIN 02506874 · not recorded Sandoz Atomoxetine · DIN 02386488 · not recorded Strattera · DIN 02279355 · not recorded Teva-Atomoxetin · DIN 02362538 · not recorded
Shortage status: resolved shortage (ended 2025-11-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02471558
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (28:92 Miscellaneous Central Nervous System Drugs) and how they are covered

Matched class: 28:92 Miscellaneous Central Nervous System Drugs

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: PIZOTYLINE Some products covered without a code (check the product listing): PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 28:92 Miscellaneous Central Nervous System Drugs

PIZOTYLINE

· 1 products · General benefit · strengths: 1mg · Tab

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

· 28 products · General benefit (19), Off-Formulary Interchangeable, not an ODB benefit (7), Listed, not a benefit (2) · strengths: 0.25mg, 0.5mg, 1mg, 1.5mg · Tab

ACAMPROSATE CALCIUM

· 1 products · Limited Use, codes 531 · strengths: 333mg · DR Tab

ENTACAPONE

· 4 products · Limited Use, codes 367 · strengths: 200mg · Tab

ALMOTRIPTAN

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 6.25mg, 12.5mg · Tab

DIMETHYL FUMARATE

· 18 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 120mg, 240mg · DR Cap

ELETRIPTAN

· 16 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 40mg · Tab

FROVATRIPTAN SUCCINATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 2.5mg · Tab

MEMANTINE HCL

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

NARATRIPTAN HYDROCHLORIDE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 1mg, 2.5mg · Tab

RIZATRIPTAN

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

SUMATRIPTAN SUCCINATE

· 37 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 6mg/0.5mL, 25mg, 50mg, 100mg · Inj Sol-Pref Syr 0.5mL Pk, Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:92 and 1 more
Full class listing Related classes: 28:08 Analgesics, 28:10 Opiate Antagonists, 28:12 Anticonvulsants, 28:16 Psychotherapeutic Agents, 28:20 C.N.S. Stimulants, 28:24 Sedatives and Hypnotics, 28:36 Antiparkinsonian Agents Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: an integral part of a total treatment program for adhd that may include other measures
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. Covered without a code on the Ontario formulary: DEXTROAMPHETAMINE SULFATE, MIXED SALT AMPHETAMINE DEXTROAMPHETAMINE SULFATE · General benefit Need for Comprehensive Treatment Program: DEXEDRINE/DEXEDRINE SPANSULE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. PM: https://pdf.hres.ca/dpd_pm/00083629.PDF; date FEB 25, 2026; DIN 01924516; fetched 2026-09-10 Product monograph GUANFACINE · Limited Use, codes 540 Need for Comprehensive Treatment Program INTUNIV XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational/vocational, social) for patients with this syndrome. PM: https://pdf.hres.ca/dpd_pm/00082036.PDF; date not captured; DIN 02409100; fetched 2026-09-10 Product monograph LISDEXAMFETAMINE DIMESYLATE · General benefit (54), Off-Formulary Interchangeable, not an ODB benefit (6) Need for Comprehensive Treatment Program VYVANSE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational/vocational, social) for patients with this syndrome. PM: https://pdf.hres.ca/dpd_pm/00081828.PDF; date 2025-09-15; DIN 02322951; fetched 2026-09-10 Product monograph METHYLPHENIDATE HCL · General benefit (43), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (3) INDICATION AND CLINICAL USE pms-METHYLPHENIDATE is indicated for the treatment of:  Attention Deficit Hyperactivity Disorder (ADHD) Need for Comprehensive Treatment Program pms-METHYLPHENIDATE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. PM: https://pdf.hres.ca/dpd_pm/00068339.PDF; date October 17, 2022; DIN 00584991; fetched 2026-09-10 Product monograph MIXED SALT AMPHETAMINE · General benefit Indications ADDERALL XR (mixed salts amphetamine extended-release capsules) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in: • Children (6 – 12 years of age) • Adolescents (13 – 17 years of age) • Adults (18 years of age or older) Need for Comprehensive Treatment Program ADDERALL XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. PM: https://pdf.hres.ca/dpd_pm/00081719.PDF; date 2025-09-12; DIN 02248808; 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 TEVA-ATOMOXETINE (atomoxetine hydrochloride) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level TEVA-ATOMOXETINE Page 3 of 64 of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forg… https://pdf.hres.ca/dpd_pm/00052053.PDF PM date: July 2, 2019 Source product: TEVA-ATOMOXETINE; DIN 02314541; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Auro-Atomoxetine: 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