BICALUTAMIDE 50 MG
BICALUTAMIDE : 50 MG · DIN 02325233 · SORRES PHARMA INC
Health Canada status: CANCELLED POST MARKET
What is BICALUTAMIDE?
BICALUTAMIDE 50 MG contains BICALUTAMIDE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02325233, held by SORRES PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 20-Jun-2014. 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 BICALUTAMIDE used for?
In combination therapy with either an LHRH analogue or surgical castration in the treatment of metastatic (Stage D2) prostate cancer.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02325233 |
|---|---|
| Brand name | BICALUTAMIDE |
| Generic / active ingredient | BICALUTAMIDE : 50 MG |
| Manufacturer | SORRES PHARMA INC |
| Strength | 50 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L02BB03 BICALUTAMIDE |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 20-Jun-2014 |
How is it administered?
One 50 mg tablet once daily with or without food. Start at the same time as LHRH analogue or after surgical castration.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly specified in the provided text (section header 'STORAGE AND STABILITY' exists but details are on page 13, which is partially cut off).
How is it supplied?
Not explicitly specified in the provided text (mentions 'Bottles' in prompt example but text only lists 'Dosage Forms, Composition and Packaging' section header).
Contraindications
Hypersensitivity; localized prostate cancer patients undergoing watchful waiting; women; children.
Warnings and precautions
Rare hepatic failure; uncommon interstitial lung disease; increased mortality in localized prostate cancer (150mg dose); cardiovascular disease risk; QTc prolongation; glucose tolerance reduction.
Is BICALUTAMIDE in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by SANIS HEALTH INC, last seen 05 May 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code L02BB03 BICALUTAMIDE. 6 of 25 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ACH-BICALUTAMIDE | 50 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | DIN 02325985 |
| BICALUTAMIDE | 50 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02519178 |
| JAMP-BICALUTAMIDE | 50 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02357216 |
| PMS-BICALUTAMIDE | 50 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02275589 |
| PRO-BICALUTAMIDE - 50 | 50 MG | TABLET | PRO DOC LIMITEE | MARKETED | DIN 02311038 |
| TEVA-BICALUTAMIDE | 50 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02270226 |
| ACCEL-BICALUTAMIDE TABLETS USP | 50 MG | TABLET | ACCEL PHARMA INC | CANCELLED PRE MARKET | DIN 02400731 |
| ACT BICALUTAMIDE | 50 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02274337 |
| AG-BICALUTAMIDE | 50 MG | TABLET | ANGITA PHARMA INC. | CANCELLED PRE MARKET | DIN 02374412 |
| APO-BICALUTAMIDE | 50 MG | TABLET | APOTEX INC | DORMANT | DIN 02296063 |
Who else supplies BICALUTAMIDE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BICALUTAMIDE appears in 158 registered pack listings across 14 markets, published on 11 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.