Baloxavir Marboxil — supply status, manufacturers & alternatives

Baloxavir Marboxil

ATC J05AX25

🇦🇺 AUST R 388092 · Roche Products Pty Ltd

In supply · Australia

Xofluza

In supply · 🇦🇺 Australia · short in🇨🇦 CA

In supply in Australia

Reading today’s signals…

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Baloxavir Marboxil
Brand names	Xofluza

ATC level 4	J05AX

Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper

Controlled substance	No

Marketing-authorisation holders	Roche Products Pty Ltd

Registrations on file	3

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇺🇸 US

US$161.97

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

—

No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

Global API supply base 🇺🇸 FDA Drug Master Files · active Type II

5 API manufacturers

Manufacturers with an active Type II Drug Master File — i.e. cleared to supply this active ingredient into the US market. A proxy for how concentrated the global manufacturing base is.

Moderate concentration risk

Changzhou Pharmaceutical FactoryMsn Laboratories Private LTDPorton Pharma Solutions LTDSinopep-Allsino Biopharmaceutical CO LTDSuzhou Ryway Biotech CO LTD

Manufacturing countries: China, India · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders3 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
XOFLUZA baloxavir marboxil	80 mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active
XOFLUZA baloxavir marboxil	20 mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active
XOFLUZA baloxavir marboxil	40 mg	—	🇦🇺 AU	Roche Products Pty Ltd	Active

For health-professional reference only. Mederti aggregates shortage and substitution information from official regulatory sources. It is not clinical advice and data may be incomplete or delayed. Confirm any substitution or supply decision against the primary regulator source, the prescriber, and current clinical references (e.g. AMH) before acting. Terms.