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

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CYPROTERONE ACETATE

All strengths: General benefit; same patient cost rules

Shared coverage and patient cost rules
StatusGeneral benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

Androcur · DIN 00704431 · 50mg · tablet

General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Androcur · DIN 00704431 Manufacturer: Amdipharm Limited; listing date 1996-10-01 Health Canada: Marketed since 2025-05-08 · brand ANDROCUR · ATC G03HA01 CYPROTERONE · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 50 MG · company Amdipharm limited · schedule Prescription
Check this DIN again · Health Canada product record

Androcur: Formulary list price $1.4000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.4000 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=7394 · Verify on the e-Formulary ↗ (DIN 00704431)

Source record
DIN 00704431: Androcur Raw flags: sec3=Y Item: 100000057; group id 152; item number 0257; lccId None; manufacturer id AMD Source form: Tab; strength: 50mg Recorded listing: General benefit Source prices (unrounded): $1.4000; ministry $1.4000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=00704431 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=7394
Interchangeable products
Cyproterone · DIN 02245898 · $1.4000 Med-Cyproterone · DIN 02390760 · $1.4000 Riva-Cyproterone · DIN 02395797 · $1.4000
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=00704431
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Cyproterone · DIN 02245898 · 50mg · tablet

General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Cyproterone · DIN 02245898 Manufacturer: A A Pharma Inc.; listing date 2004-07-20 Health Canada: Marketed since 2011-03-22 · brand CYPROTERONE · ATC G03HA01 CYPROTERONE · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 50 MG · company Aa pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

Cyproterone: Formulary list price $1.4000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.4000 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=70015 · Verify on the e-Formulary ↗ (DIN 02245898)

Source record
DIN 02245898: Cyproterone Raw flags: sec3=Y Item: 100000057; group id 152; item number 0257; lccId None; manufacturer id AAP Source form: Tab; strength: 50mg Recorded listing: General benefit Source prices (unrounded): $1.4000; ministry $1.4000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245898 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=70015
Interchangeable products
Androcur · DIN 00704431 · $1.4000 Med-Cyproterone · DIN 02390760 · $1.4000 Riva-Cyproterone · DIN 02395797 · $1.4000
Shortage status: resolved shortage (ended 2019-02-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02245898
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Med-Cyproterone · DIN 02390760 · 50mg · tablet

General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Med-Cyproterone · DIN 02390760 Manufacturer: Generic Medical Partners Inc.; listing date 2013-11-28 Health Canada: Marketed since 2012-10-02 · brand MED-CYPROTERONE · ATC G03HA01 CYPROTERONE · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 50 MG · company Generic medical partners inc · schedule Prescription
Check this DIN again · Health Canada product record

Med-Cyproterone: Formulary list price $1.4000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.4000 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=87616 · Verify on the e-Formulary ↗ (DIN 02390760)

Source record
DIN 02390760: Med-Cyproterone Raw flags: sec3=Y Item: 100000057; group id 152; item number 0257; lccId None; manufacturer id GMP Source form: Tab; strength: 50mg Recorded listing: General benefit Source prices (unrounded): $1.4000; ministry $1.4000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02390760 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87616
Interchangeable products
Androcur · DIN 00704431 · $1.4000 Cyproterone · DIN 02245898 · $1.4000 Riva-Cyproterone · DIN 02395797 · $1.4000
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=02390760
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Riva-Cyproterone · DIN 02395797 · 50mg · tablet

General benefitMarketed · checked 2026-09-02
Write on scriptno code needed
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Riva-Cyproterone · DIN 02395797 Manufacturer: Laboratoire Riva Inc.; listing date 2026-04-30 Health Canada: Marketed since 2012-11-28 · brand RIVA-CYPROTERONE · ATC G03HA01 CYPROTERONE · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 50 MG · company Laboratoire riva inc. · schedule Prescription
Check this DIN again · Health Canada product record

Riva-Cyproterone: Formulary list price $1.4000/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.4000 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=88085 · Verify on the e-Formulary ↗ (DIN 02395797)

Source record
DIN 02395797: Riva-Cyproterone Raw flags: sec3=Y Item: 100000057; group id 152; item number 0257; lccId None; manufacturer id RIA Source form: Tab; strength: 50mg Recorded listing: General benefit Source prices (unrounded): $1.4000; ministry $1.4000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02395797 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88085
Interchangeable products
Androcur · DIN 00704431 · $1.4000 Cyproterone · DIN 02245898 · $1.4000 Med-Cyproterone · DIN 02390760 · $1.4000
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=02395797
Shortage record checked 2026-09-13T08:10:21.292534+00:00

CYPROTERONE ACETATE & ETHINYL ESTRADIOL

All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules

Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 Manufacturer: Ambicare Pharmaceuticals Inc.; listing date 2026-05-29 Health Canada: Marketed since 2026-03-19 · brand AMB-CYPROTERONE ACETATE / ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Ambicare pharmaceuticals 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=106712 · Verify on the e-Formulary ↗ (DIN 02564424)

Source record
DIN 02564424: AMB-Cyproterone Acetate/EthinylEstradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id AMB Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02564424 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106712
Interchangeable products
Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded
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=02564424
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Cleo-35 · DIN 02436736 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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
Cleo-35 · DIN 02436736 Manufacturer: Altius Healthcare Inc.; listing date 2024-10-31 Health Canada: Marketed since 2018-05-04 · brand CLÉO -35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients ETHINYL ESTRADIOL 0.035 MG, CYPROTERONE ACETATE 2 MG · company Altius healthcare 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=92104 · Verify on the e-Formulary ↗ (DIN 02436736)

Source record
DIN 02436736: Cleo-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id ALH Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02436736 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92104
Interchangeable products
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded
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=02436736
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Cyestra-35 · DIN 02290308 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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
Cyestra-35 · DIN 02290308 Manufacturer: Paladin Labs Inc.; listing date 2007-12-19 Health Canada: Marketed since 2026-02-17 · brand CYESTRA-35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Knight therapeutics 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=77558 · Verify on the e-Formulary ↗ (DIN 02290308)

Source record
DIN 02290308: Cyestra-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id PAL Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02290308 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=77558
Interchangeable products
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded
Shortage status: resolved shortage (ended 2026-03-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02290308
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Diane-35 · DIN 02233542 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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
Diane-35 · DIN 02233542 Manufacturer: Bayer Inc., Consumer Care Division; listing date 2007-12-19 Health Canada: Marketed since 2007-12-17 · brand DIANE-35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 35 MCG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Diane-35: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=53444 · Verify on the e-Formulary ↗ (DIN 02233542)

Source record
DIN 02233542: Diane-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id BAY Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02233542 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=53444
Interchangeable products
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded
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=02233542
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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
Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 Manufacturer: Ranbaxy Pharmaceuticals Canada Inc.; listing date 2015-05-28 Health Canada: Marketed since 2020-08-05 · brand TARO-CYPROTERONE/ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Sun pharma canada 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=90968 · Verify on the e-Formulary ↗ (DIN 02425017)

Source record
DIN 02425017: Ran-Cyproterone/Ethinyl Estradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id RAN Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02425017 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90968
Interchangeable products
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded
Shortage status: resolved shortage (ended 2026-08-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02425017
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · 2mg & 0.035mg · tablets, 21-pack

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
1 brand, same coverage
Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 Manufacturer: Teva Canada Limited; listing date 2008-12-03 Health Canada: Marketed since 2018-03-08 · brand TEVA-CYPROTERONE / ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Teva canada limited · 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=79517 · Verify on the e-Formulary ↗ (DIN 02309556)

Source record
DIN 02309556: Teva-Cyproterone/Ethinyl Estradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id TEV Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3400; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02309556 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79517
Interchangeable products
AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded
Shortage status: resolved shortage (ended 2023-06-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02309556
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary classes and how they are covered

Other drugs in the same formulary class (10:00 ANTINEOPLASTIC AGENTS) and how they are covered

Matched class: 10:00 ANTINEOPLASTIC 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: ABIRATERONE ACETATE, ALTRETAMINE, ANASTROZOLE, BUSERELIN ACETATE, BUSULFAN, CAPECITABINE, CHLORAMBUCIL, DAUNORUBICIN, DEGARELIX ACETATE, ETOPOSIDE, EXEMESTANE, FLUOROURACIL & SALICYLIC ACID, FULVESTRANT, GOSERELIN ACETATE, HYDROXYUREA, IMATINIB MESYLATE, LETROZOLE, LEUPROLIDE ACETATE, MELPHALAN, MERCAPTOPURINE, MITOTANE, PROCARBAZINE HCL, TEMOZOLOMIDE, THIOGUANINE, TRIPTORELIN PAMOATE Some products covered without a code (check the product listing): BICALUTAMIDE, CYCLOPHOSPHAMIDE, FLUTAMIDE, LOMUSTINE (CCNU), MEGESTROL ACETATE, METHOTREXATE, TAMOXIFEN CITRATE, VINCRISTINE SULFATE 10:00 ANTINEOPLASTIC AGENTS

ABIRATERONE ACETATE

· 18 products · General benefit · strengths: 250mg, 500mg · Tab

ALTRETAMINE

· 1 products · General benefit · strengths: 50mg · Cap

ANASTROZOLE

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

BICALUTAMIDE

· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 50mg · Tab

BUSERELIN ACETATE

· 4 products · General benefit · strengths: 6.3mg, 9.45mg, 1mg/mL · Implant Kit, Inj Sol-5.5mL Pk, Nas Sp-10mL Pk

BUSULFAN

· 1 products · General benefit · strengths: 2mg · Tab

CAPECITABINE

· 15 products · General benefit · strengths: 150mg, 500mg · Tab

CHLORAMBUCIL

· 1 products · General benefit · strengths: 2mg · Tab

CYCLOPHOSPHAMIDE

· 3 products · General benefit (2), Listed, not a benefit (1) · strengths: 25mg, 50mg · Tab

DAUNORUBICIN

· 1 products · General benefit · strengths: · Inj Pd-20mg Pk

DEGARELIX ACETATE

· 2 products · General benefit · strengths: 80mg, 120mg · Pd for Inj-Vial Pk

ETOPOSIDE

· 1 products · General benefit · strengths: 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 10:00 and 34 more
Full class listing Related classes:

Other drugs in the same formulary class (68:32 Progestogens and Oral Contraceptives) and how they are covered

Matched class: 68:32 Progestogens and Oral Contraceptives

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: DESOGESTREL & ETHINYL ESTRADIOL, DROSPIRENONE, DROSPIRENONE & ETHINYL ESTRADIOL, ETHINYL ESTRADIOL & NORETHINDRONE, ETHINYL ESTRADIOL & NORETHINDRONE ACETATE, LEVONORGESTREL Some products covered without a code (check the product listing): ETHINYL ESTRADIOL & LEVONORGESTREL, MEDROXYPROGESTERONE ACETATE, NORETHINDRONE, NORGESTIMATE & ETHINYL ESTRADIOL 68:32 Progestogens and Oral Contraceptives

DESOGESTREL & ETHINYL ESTRADIOL

· 12 products · General benefit · strengths: 0.15mg & 0.03mg, 3 Phase · Tab-21 Pk, Tab-28 Pk, Tabs-21 Pk, Tabs-28 Pk

DROSPIRENONE

· 1 products · General benefit · strengths: 4mg · Tab-28 Tab Pk

DROSPIRENONE & ETHINYL ESTRADIOL

· 9 products · General benefit · strengths: 3.0mg & 0.03mg, 3.0mg & 0.02mg · Tab-21 Pk, Tab-28 Pk

ETHINYL ESTRADIOL & LEVONORGESTREL

· 20 products · General benefit (18), Off-Formulary Interchangeable, not an ODB benefit (2) · strengths: 20mcg & 100mcg, 0.03mg & 0.15mg, 3 Phase · Tab-21 Pk, Tab-28 Pk, Tab-91 Pk

ETHINYL ESTRADIOL & NORETHINDRONE

· 6 products · General benefit · strengths: 0.035mg & 0.5mg, 0.035mg & 1mg, 3 Phase · Tab-21 Pk, Tab-28 Pk

ETHINYL ESTRADIOL & NORETHINDRONE ACETATE

· 4 products · General benefit · strengths: 0.02mg & 1mg, 0.03mg & 1.5mg · Tab-21 Pk, Tab-28 Pk

LEVONORGESTREL

· 4 products · General benefit · strengths: 1.5mg · Tab-1 Tab Pk

MEDROXYPROGESTERONE ACETATE

· 10 products · Temporary benefit (2), General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (3), General benefit (4), Listed, not a benefit (1) · strengths: 150mg/mL, 2.5mg, 5mg, 10mg, 100mg · Inj Sol-1mL Pref Syr, Tab

NORETHINDRONE

· 3 products · Listed, not a benefit (1), General benefit (2) · strengths: 0.35mg · Tab-28 Pk

NORGESTIMATE & ETHINYL ESTRADIOL

· 10 products · Listed, not a benefit (4), General benefit (6) · strengths: 3 Phase · Tab-21 Pk, Tab-28 Pk

DIENOGEST

· 5 products · Limited Use, codes 432 · strengths: 2mg · Tab

PROGESTERONE

· 8 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:32
Full class listing Related classes: 68:04 Corticosteroids, 68:08 Androgens, 68:12 Contraceptives, 68:16 Estrogens, 68:20 Anti-Diabetic Agents, 68:24 Parathyroid Agents, 68:28 Pituitary Agents, 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
1. INDICATIONS ANDROCUR (cyproterone acetate) is indicated for: • the palliative treatment of patients with advanced prostatic carcinoma https://pdf.hres.ca/dpd_pm/00080518.PDF PM date: APR 26, 1985 Source product: ANDROCUR; DIN 00704431; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE DIANE-35 (cyproterone acetate and ethinyl estradiol) is indicated for:  treatment of women with severe acne, with associated symptoms of androgenization, including seborrhea and mild hirsutism. DIANE-35 should be used only when acne is unresponsive to topical therapy and oral antibiotic treatments. Note: DIANE-35 should not be prescribed for the purpose of contraception alone. However, when taken as recommended (see DOSAGE AND ADMINISTRATION), DIANE-35 will provide reliable contraception in patients treated for the above clinical conditions. If patient compliance is uncertain and contraception is necessary, then a supplementary non-hormonal contraceptive method should be considered. Geriatrics DIANE-35 is not indicated after menopause. Pediatrics DIANE-35 is only indicated after menarche. https://pdf.hres.ca/dpd_pm/00038573.PDF PM date: March 16, 2017 Source product: DIANE-35; DIN 02233542; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For AMB-Cyproterone Acetate/EthinylEstradiol, Cleo-35, Cyestra-35, Diane-35, Ran-Cyproterone/Ethinyl Estradiol, Teva-Cyproterone/Ethinyl Estradiol: 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