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ESLICARBAZEPINE ACETATE

All products: Limited Use (codes 430)

Other products in the same Health Canada class (N03A, N03AF) — coverage varies; not interchangeable

  • Carbamazepine (Tegretol): general benefit, Limited Use, Not a benefit, Listing status unconfirmed
  • Oxcarbazepine (Trileptal): not a benefit
  • Rufinamide (Banzel): not a benefit
  • Clonazepam (Rivotril): general benefit
  • Divalproex (Epival): general benefit
  • Ethosuximide (Zarontin): general benefit

14 more in the class list below

Apo-Eslicarbazepine · DIN 02537974 · 800mg · tablet

Limited Use — Reason for Use code 430 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 430 required
Write on scriptLU code 430 (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.
Ontario Limited Use criteria — code 430
Reason for Use code 430 As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc. Coverage limit: LU Authorization Period: Indefinite
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
Apo-Eslicarbazepine · DIN 02537974 Manufacturer: Apotex Inc.; listing date 2025-06-30 Health Canada: Marketed since 2025-05-06 · brand APO-ESLICARBAZEPINE · ATC N03AF04 ESLICARBAZEPINE · form Tablet · route Oral · ingredients ESLICARBAZEPINE ACETATE 800 MG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product record

Apo-Eslicarbazepine: Formulary list price $4.9350/unit (unit not stated in source; not the patient's cost)

Ministry pays: $4.9350 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=102672 · Verify on the e-Formulary ↗ (DIN 02537974)

Source record
DIN 02537974: Apo-Eslicarbazepine Raw flags: sec12=Y, sec3=Y Item: 281200172; group id 428; item number 1067; lccId 00259; manufacturer id APX Source form: Tab; strength: 800mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4.9350; ministry $4.9350 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02537974 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102672
Interchangeable products
Aptiom · DIN 02426897 · $4.9350 Auro-Eslicarbazepine · DIN 02527464 · $4.9350
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=02537974
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (28:12 Anticonvulsants) and how they are covered

Matched class: 28:12 Anticonvulsants

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: CLONAZEPAM, DIVALPROEX SODIUM, ETHOSUXIMIDE, LAMOTRIGINE, VALPROATE SODIUM Some products covered without a code (check the product listing): CARBAMAZEPINE, GABAPENTIN, PHENYTOIN (DIPHENYLHYDANTOIN), PHENYTOIN (DIPHENYLHYDANTOIN) SODIUM, PREGABALIN, PRIMIDONE, TOPIRAMATE, VALPROIC ACID 28:12 Anticonvulsants

CARBAMAZEPINE

· 15 products · Listed, not a benefit (3), General benefit (6), Temporary benefit (2), Limited Use, codes 67 (4) · strengths: 100mg, 200mg, 400mg, 100mg/5mL · Chew Tab, ER Tab, LA Tab, Oral Susp, Tab

OXCARBAZEPINE

· 12 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 150mg, 300mg, 600mg · Tab

RUFINAMIDE

· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 200mg, 400mg · Tab

CLONAZEPAM

· 9 products · General benefit · strengths: 0.5mg, 2mg · Tab

DIVALPROEX SODIUM

· 9 products · General benefit · strengths: 125mg, 250mg, 500mg · Ent Tab

ETHOSUXIMIDE

· 4 products · General benefit · strengths: 250mg, 50mg/mL · Cap, O/L

LAMOTRIGINE

· 28 products · General benefit · strengths: 25mg, 100mg, 150mg · Tab

PHENYTOIN (DIPHENYLHYDANTOIN)

· 4 products · General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (2), General benefit (2) · strengths: 6mg/mL, 25mg/mL, 50mg · O/L, Tab

PHENYTOIN (DIPHENYLHYDANTOIN) SODIUM

· 4 products · General benefit (3), Limited Use, codes 481, 657 (1) · strengths: 30mg, 100mg, 50mg/mL · Cap, Inj Sol (Preservative Free)

PRIMIDONE

· 4 products · General benefit (2), Listed, not a benefit (2) · strengths: 125mg, 250mg · Tab

TOPIRAMATE

· 54 products · Limited Use, codes 321 (2), Off-Formulary Interchangeable, not an ODB benefit (3), General benefit (49) · strengths: 15mg, 25mg, 50mg, 100mg, 200mg · Sprinkle Cap, Tab

VALPROATE SODIUM

· 5 products · General benefit · strengths: 50mg/mL · O/L Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:12 and 11 more
Full class listing Related classes: 28:08 Analgesics, 28:10 Opiate Antagonists, 28:16 Psychotherapeutic Agents, 28:20 C.N.S. Stimulants, 28:24 Sedatives and Hypnotics, 28:36 Antiparkinsonian Agents, 28:92 Miscellaneous Central Nervous System Drugs 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 Auro-Eslicarbazepine (eslicarbazepine acetate) is indicated as: • Monotherapy in the management of partial-onset seizures in adult patients with epilepsy. All patients who participated in the monotherapy trial were newly or recently diagnosed with epilepsy (see CLINICAL TRIALS). • Adjunctive therapy in the management of adults, and children above 6 years of age, with partial-onset seizures who are not satisfactorily controlled with conventional therapy. Geriatrics (>65 years of age) There were insufficient numbers of elderly patients who completed partial-onset seizure-controlled trials (N=39) to determine the safety and efficacy of eslicarbazepine acetate in this patient population. Caution should be exercised during dose titration, and age-associated decrease in renal clearance should be considered in elderly patients [see also WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics; ADVERSE REACTIONS, Comparison of Gender, Age and Race, and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics]. Pediatrics (<18 years of age) The safety and efficacy of eslicarbazepine acetate has not been e… https://pdf.hres.ca/dpd_pm/00080459.PDF PM date: not printed or not captured Source product: AURO-ESLICARBAZEPINE; DIN 02527421; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.