Ibrutinib shortage — IT supply status & alternatives

Ibrutinib

—

🇦🇺 AUST R 319356 · Janssen-Cilag Pty Ltd

In supply · Australia

Imbruvica

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇫🇷 FR

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$5194.37DPMQ A$5430.62details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Ibrutinib
Brand names	Imbruvica
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper
Controlled substance	No
Marketing-authorisation holders	Janssen-Cilag Pty Ltd
Registrations on file	4
Patient information leaflet (PIL)	Not on file
Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 PBS · July 2026

🇦🇺 AU

● Official price on file

Ex-manufacturer

A$5194.37

AEMP

Dispensed (DPMQ)

A$5430.62

incl. fees

Pack

ibrutinib 280 mg tablet, 30

Source: PBSEffective July 2026 · AUD

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

17 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.

Low concentration risk

Synthimed Labs Private LTDMsn Laboratories Private LTDWavelength Enterprises LTDScinopharm Taiwan LTDSun Pharmaceutical Industries LTDTapi Nl BV+11 more

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

Verified timeline regulator events

🇫🇷 29 June 2026

high reported

🇮🇹 12 June 2026

critical reported

🇳🇴 7 Apr 2026

Shortage resolved

🇮🇹 20 Dec 2024

Shortage resolved

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders4 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
IMBRUVICA ibrutinib	140 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
IMBRUVICA ibrutinib	280 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
IMBRUVICA ibrutinib	420 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
IMBRUVICA ibrutinib	560 mg	—	🇦🇺 AU	Janssen-Cilag 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.