ESBRIET 801 MG
PIRFENIDONE : 801 MG · DIN 02464500 · HOFFMANN-LA ROCHE LIMITED
Health Canada status: MARKETED
What is ESBRIET?
ESBRIET 801 MG contains PIRFENIDONE : 801 MG. It is listed in the Health Canada Drug Product Database under DIN 02464500, held by HOFFMANN-LA ROCHE LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Jul-2017. 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 ESBRIET used for?
ESBRIET® (pirfenidone) is indicated for treatment of idiopathic pulmonary fibrosis (IPF) in adults.
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 | 02464500 |
|---|---|
| Brand name | ESBRIET |
| Generic / active ingredient | PIRFENIDONE : 801 MG |
| Manufacturer | HOFFMANN-LA ROCHE LIMITED |
| Strength | 801 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L04AX05 PIRFENIDONE |
| AHFS class | 48:02.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-Jul-2017 |
| Original market date | 2017-07-26 00:00:00 |
How is it stored and handled?
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How is it supplied?
ESBRIET capsules are supplied in 250 mL white high-density polyethylene (HDPE) bottle with child-resistant closure containing 270 capsules, or in treatment packs as follows: 2-week treatment initiation pack 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing), for a total of 63 capsules per pack. ESBRIET tablets are supplied in HDPE bottle(s) with child-resistant closures in the following packaging formats: 267 mg Carton containing one bottle with 21 tablets, 42 tablets or 270 tablets 801 mg Carton containing one bottle with 90 tablets
What can be used instead?
Other Canadian products sharing ATC code L04AX05 PIRFENIDONE. 12 of 19 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 |
|---|---|---|---|---|---|
| AURO-PIRFENIDONE | 267 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02537753 |
| AURO-PIRFENIDONE | 801 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02537761 |
| ESBRIET | 267 MG | TABLET | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02464489 |
| JAMP PIRFENIDONE | 267 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02509938 |
| JAMP PIRFENIDONE | 267 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02514702 |
| JAMP PIRFENIDONE | 801 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02514710 |
| M-PIRFENIDONE | 267 MG | TABLET | MANTRA PHARMA INC | MARKETED | DIN 02550644 |
| M-PIRFENIDONE | 801 MG | TABLET | MANTRA PHARMA INC | MARKETED | DIN 02550652 |
| SANDOZ PIRFENIDONE CAPSULES | 267 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02488833 |
| SANDOZ PIRFENIDONE TABLETS | 267 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02488507 |
Who else supplies PIRFENIDONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. PIRFENIDONE appears in 148 registered pack listings across 12 markets, published on 10 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.