ACTONEL DR 35 MG — DIN 02370417
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG · ABBVIE CORPORATION · TABLET (DELAYED-RELEASE) · wholesale supply in Canada
Health Canada status: MARKETED
What is ACTONEL DR?
ACTONEL DR 35 MG contains RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG. It is listed in the Health Canada Drug Product Database under DIN 02370417, held by ABBVIE CORPORATION, supplied as TABLET (DELAYED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 22-May-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is ACTONEL DR used for?
Treatment/prevention of postmenopausal osteoporosis; osteoporosis in men; glucocorticoid-induced osteoporosis; Paget’s disease of bone. ACTONEL DR is for postmenopausal osteoporosis only.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Risedronic Acid in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
22 holders have a Canadian DIN containing Risedronic Acid, across 40 DINs, of which 20 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| TEVA CANADA LIMITED | 4 | 4 | TEVA-RISEDRONATE | Sourceable in Canada |
| ABBVIE CORPORATION | 3 | 3 | ACTONEL, ACTONEL DR | Sourceable in Canada |
| SANIS HEALTH INC | 4 | 2 | RISEDRONATE | Sourceable in Canada |
| APOTEX INC | 2 | 2 | APO-RISEDRONATE | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-RISEDRONATE | Sourceable in Canada |
| AURO PHARMA INC | 4 | 1 | AURO-RISEDRONATE | Sourceable in Canada |
| SIVEM PHARMACEUTICALS ULC | 2 | 1 | RISEDRONATE | Sourceable in Canada |
| AA PHARMA INC | 1 | 1 | AA-RISEDRONATE DR | Sourceable in Canada |
| LABORATOIRE RIVA INC. | 1 | 1 | RIVA-RISEDRONATE | Sourceable in Canada |
| NB PHARMA INC. 208 2700 Rue Jean-Perrin Québec Quebec Canada G2C 1S9 | 1 | 1 | NB-RISEDRONATE | Sourceable in Canada |
| PRO DOC LIMITEE | 1 | 1 | RISEDRONATE | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | SANDOZ RISEDRONATE | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 35 MG |
|---|---|
| Dosage form | TABLET (DELAYED-RELEASE) |
| Route | ORAL |
| Pack configuration (monograph) | 35 mg: Cartons of 4 blister-packaged tablets. 150 mg: Cartons of 1 blister-packaged tablet. |
| Storage | Not explicitly detailed in provided text (standard reference to section 11 which is not fully transcribed). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Risedronic Acid |
|---|---|
| ATC code | M05BA07 |
| AHFS class | 92:24.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02370417 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2370417 |
| Brand name | ACTONEL DR |
| Generic / active ingredient | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) : 35 MG |
| Market authorization holder | ABBVIE CORPORATION |
| Health Canada schedule | Prescription |
| ATC code | M05BA07 |
| ATC anatomical main group | M — Musculo-skeletal system |
| ATC therapeutic subgroup | M05BA |
| Current status | MARKETED |
| Status date | 22-May-2025 |
| Original market date | 2011-08-10 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
ACTONEL: Take on empty stomach 30 min before food/drink with 120mL water; stay upright for 30 min. ACTONEL DR: Take with breakfast with 120mL water; stay upright for 30 min. Do not chew/crush.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to risedronate sodium or any ingredient in the formulation; Hypocalcemia.
Warnings and precautions
Upper GI disorders (esophagitis, ulcers); Osteonecrosis of the jaw (ONJ); Atypical femur fractures; Severe musculoskeletal pain; Ocular disturbances (uveitis, scleritis).
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
20 of 40 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AA-RISEDRONATE DR | 35 MG | TABLET (DELAYED-RELEASE) | AA PHARMA INC | MARKETED | 02493268 |
| ACTONEL | 150 MG | TABLET | ABBVIE CORPORATION | MARKETED | 02316838 |
| ACTONEL | 35 MG | TABLET | ABBVIE CORPORATION | MARKETED | 02246896 |
| APO-RISEDRONATE | 150 MG | TABLET | APOTEX INC | MARKETED | 02377721 |
| APO-RISEDRONATE | 35 MG | TABLET | APOTEX INC | MARKETED | 02353687 |
| AURO-RISEDRONATE | 35 MG | TABLET | AURO PHARMA INC | MARKETED | 02406306 |
| NB-RISEDRONATE | Strength | Tablet | NB PHARMA INC. 208 2700 Rue Jean-Perrin Québec Quebec Canada G2C 1S9 | MARKETED | 02561859 |
| PMS-RISEDRONATE | 150 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02424177 |
| PMS-RISEDRONATE | 35 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02302209 |
| RISEDRONATE | 35 MG | TABLET | SANIS HEALTH INC | MARKETED | 02370255 |
2 · Same class — other molecules in ATC M05BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Risedronic Acid | AA-RISEDRONATE DR · ACTONEL · ACTONEL DR · APO-RISEDRONATE · +15 more | 40 | 20 | Yes |
| Alendronic Acid | ACCEL-ALENDRONATE · ACH-ALENDRONATE · ACT ALENDRONATE · AG-ALENDRONATE · +31 more | 79 | 17 | Yes |
| Zoledronic Acid | ACLASTA · ACT ZOLEDRONIC ACID · ACT ZOLEDRONIC ACID CONCENTRATE · JAMP-ZOLEDRONIC ACID · +14 more | 26 | 9 | Yes |
| Pamidronic Acid | AREDIA · AREDIA 30MG · AREDIA 90MG · AREDIA LIQ INJ 3MG/ML · +6 more | 23 | 8 | Yes |
| Clodronic Acid | BONEFOS · CLASTEON · OSTAC CAP 400MG | 4 | 1 | Yes |
| Etidronic Acid | ACT ETIDRONATE · APO-ETIDRONATE · DIDRONEL INJ 50MG/ML · DIDRONEL TAB 200MG · +2 more | 9 | 0 | Not in Canada |
| Ibandronic Acid | BONDRONAT | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC M05B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| M05BX | Burosumab · Denosumab · Romosozumab | 9 | 8 |
| M05BB | Alendronic Acid And Cholecalciferol · Etidronic Acid And Calcium, Sequential · Risedronic Acid And Calcium, Sequential · Risedronic Acid, Calcium And Cholecalciferol, Sequential | 22 | 6 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.