LETYBO 50 UNIT — DIN 02528134
LETIBOTULINUMTOXINA : 50 UNIT · HUGEL CANADA INC. · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: APPROVED
What is LETYBO?
LETYBO 50 UNIT contains LETIBOTULINUMTOXINA : 50 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02528134, held by HUGEL CANADA INC., supplied as POWDER FOR SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as approved, status dated 07-Nov-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
Is there a generic Botulinum Toxin 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.
7 holders have a Canadian DIN containing Botulinum Toxin, across 16 DINs, of which 12 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 |
|---|---|---|---|---|
| ABBVIE CORPORATION | 5 | 4 | BOTOX, BOTOX COSMETIC | Sourceable in Canada |
| MERZ PHARMACEUTICALS GMBH | 4 | 3 | XEOMIN, XEOMIN COSMETIC | Sourceable in Canada |
| IPSEN BIOPHARMACEUTICALS CANADA INC | 2 | 2 | DYSPORT THERAPEUTIC | Sourceable in Canada |
| HUGEL CANADA INC. | 2 | 1 | LETYBO | Sourceable in Canada |
| EVOLUS INCORPORATED | 1 | 1 | NUCEIVA | Sourceable in Canada |
| IPSEN BIOPHARMACEUTICALS CANADA INC SUITE 500 5050 Satellite Drive Mississauga Ontario Canada L4W 0G1 | 1 | 1 | DYSPORT AESTHETIC | Sourceable in Canada |
| SOLSTICE NEUROSCIENCES, LLC, A SUBSIDIARY OF MDD US OPERATIONS, LLC | 1 | 0 | MYOBLOC | No marketed DIN |
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 | 50 UNIT |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAMUSCULAR |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Botulinum Toxin |
|---|---|
| ATC code | M03AX01 |
| AHFS class | 12:20.20.24 |
| 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) | 02528134 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2528134 |
| Brand name | LETYBO |
| Generic / active ingredient | LETIBOTULINUMTOXINA : 50 UNIT |
| Market authorization holder | HUGEL CANADA INC. |
| Health Canada schedule | Prescription |
| ATC code | M03AX01 |
| ATC anatomical main group | M — Musculo-skeletal system |
| ATC therapeutic subgroup | M03AX |
| Current status | APPROVED |
| Status date | 07-Nov-2024 |
| Original market date | 2023-06-20 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
12 of 16 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| BOTOX | 200 UNIT | POWDER FOR SOLUTION | ABBVIE CORPORATION | MARKETED | 02531585 |
| BOTOX | 50 UNIT | POWDER FOR SOLUTION | ABBVIE CORPORATION | MARKETED | 02531577 |
| BOTOX | 100 UNIT | POWDER FOR SOLUTION | ABBVIE CORPORATION | MARKETED | 01981501 |
| BOTOX COSMETIC | 100 UNIT | POWDER FOR SOLUTION | ABBVIE CORPORATION | MARKETED | 02243721 |
| DYSPORT AESTHETIC | Strength | Powder For Solution | IPSEN BIOPHARMACEUTICALS CANADA INC SUITE 500 5050 Satellite Drive Mississauga Ontario Canada L4W 0G1 | MARKETED | 02387735 |
| DYSPORT THERAPEUTIC | 500 UNIT | POWDER FOR SOLUTION | IPSEN BIOPHARMACEUTICALS CANADA INC | MARKETED | 02456117 |
| DYSPORT THERAPEUTIC | 300 UNIT | POWDER FOR SOLUTION | IPSEN BIOPHARMACEUTICALS CANADA INC | MARKETED | 02460203 |
| LETYBO | 100 UNIT | POWDER FOR SOLUTION | HUGEL CANADA INC. | MARKETED | 02528142 |
| NUCEIVA | 100 UNIT | POWDER FOR SOLUTION | EVOLUS INCORPORATED | MARKETED | 02480158 |
| XEOMIN | 100 UNIT | POWDER FOR SOLUTION | MERZ PHARMACEUTICALS GMBH | MARKETED | 02324032 |
2 · Same class — other molecules in ATC M03AX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Botulinum Toxin | BOTOX · BOTOX COSMETIC · DYSPORT AESTHETIC · DYSPORT THERAPEUTIC · +5 more | 16 | 12 | Yes |
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 M03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| M03AC | Atracurium · Cisatracurium · Doxacurium Chloride · Gallamine · Mivacurium Chloride · +3 more | 44 | 7 |
| M03AB | Suxamethonium | 9 | 3 |
| M03AA | Dimethyltubocurarine · Tubocurarine | 3 | 0 |
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?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.