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TERIPARATIDE

All injection strengths: Limited Use (codes 635)

Osnuvo · DIN 02495589 · 250mcg/mL · injection solution-3mL Cart Pk

Limited Use — Reason for Use code 635 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 635 required
Write on scriptLU code 635 (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 635
Reason for Use code 635 For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria: - 65 years of age or older; AND - Has a documented bone mineral density [BMD] T-score of less than or equal to -3; AND - Has a history of prior fragility fracture(s); AND - Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture. Note: The maximum lifetime exposure to teriparatide for an individual patient is 24 months Coverage limit: LU Authorization Period: 2 years 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 Teriparatide Brand(s): Forteo and generics DOSAGE FORM/ STRENGTH: Please refer to the ODB Formulary for a list of funded products Effective with the May 31, 2024 Ontario Drug Benefit Formulary/ Comparative Drug Index update, Teriparatide as Forteo has transitioned to the ODB formulary with its generic versions. Also, please note that the Teriparatide biosimilar (Osnuvo) is also publicly funded as a limited use benefit on the Ontario Drug Benefit formulary effective on September 29, 2022. Refer to the ODB formulary for the Limited Use Criteria for all teriparatide products. 401 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 401, record 230, 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 ↗)
No interchangeable product listed in the Ontario extract
Osnuvo · DIN 02495589 Manufacturer: Avir Pharma Inc.; listing date 2022-09-29 Health Canada: Marketed since 2020-10-27 · brand OSNUVO · ATC H05AA02 TERIPARATIDE · form Solution · route Subcutaneous · ingredients TERIPARATIDE 250 MCG/ML · company Avir pharma inc. · schedule Schedule d, Prescription
Check this DIN again · Health Canada product record

Osnuvo: Formulary list price $565.2600/unit (unit not stated in source; not the patient's cost)

Ministry pays: $565.2600 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=98548 · Verify on the e-Formulary ↗ (DIN 02495589)

Source record
DIN 02495589: Osnuvo Raw flags: sec12=Y, sec3=Y Item: 682400015; group id 789; item number 1919; lccId 00361; manufacturer id AVP Source form: Inj Sol-3mL Cart Pk; strength: 250mcg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $565.2600; ministry $565.2600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495589 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98548
Shortage status: resolved shortage (ended 2023-03-17); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02495589
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (68:24 Parathyroid Agents) and how they are covered

Matched class: 68:24 Parathyroid Agents

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): CALCITONIN (SALMON SYNTHETIC) 68:24 Parathyroid Agents

CALCITONIN (SALMON SYNTHETIC)

· 3 products · General benefit (1), General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1), Temporary benefit (1) · strengths: 100IU/mL, 400IU/2mL, 200IU/mL · Inj Sol-1mL Pk, Inj Sol-2mL Pk, Inj Sol-2mL Vial Pk (With Preservative) Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:24
Full class listing Related classes: 68:04 Corticosteroids, 68:08 Androgens, 68:12 Contraceptives, 68:16 Estrogens, 68:20 Anti-Diabetic Agents, 68:28 Pituitary Agents, 68:32 Progestogens and Oral Contraceptives, 68:36 Thyroids, 68:38 Anti-Thyroids 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-TERIPARATIDE INJECTION is indicated: • For the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. • To increase bone mass in men with primary or hypogonadal severe osteoporosis who have failed or are intolerant to previous osteoporosis therapy. The effects of teriparatide on risk for fracture in men have not been demonstrated. • For the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture. The diagnosis of severe osteoporosis may be confirmed by the finding of low bone mass or the presence or history of osteoporotic fracture. While non-vertebral fractures are usually clinically apparent, vertebral fractures also may be manifested by back pain, height loss, or kyphosis. Teva-Teriparatide Injection Page 3 of 61 Geriatrics: Of the patients receiving teriparatide in the osteoporosis treatment trial of 1637 postmenopausal women, 75% were 6… https://pdf.hres.ca/dpd_pm/00070471.PDF PM date: April 17, 2023 Source product: TEVA-TERIPARATIDE INJECTION; DIN 02486423; 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

Teriparatide (Forteo and generics)

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 401

Teriparatide Brand(s): Forteo and generics DOSAGE FORM/ STRENGTH: Please refer to the ODB Formulary for a list of funded products
Effective with the May 31, 2024 Ontario Drug Benefit Formulary/ Comparative Drug Index update, Teriparatide as Forteo has transitioned to the ODB formulary with its generic versions. Also, please note that the Teriparatide biosimilar (Osnuvo) is also publicly funded as a limited use benefit on the Ontario Drug Benefit formulary effective on September 29, 2022. Refer to the ODB formulary for the Limited Use Criteria for all teriparatide products.
401

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