Bicalutamide shortage — AU supply status & alternatives

Bicalutamide

ATC L02BB03

🇦🇺 AUST R 54639 · AstraZeneca Pty Ltd

In shortage · Australia

BicaloxCasodexBicalutamida StadaCALUTEX bicalutamide

In declared shortage · 🇦🇺 Australia & also short in🇨🇦 CA🇮🇹 IT

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AUAEMPA$36.35DPMQ A$52.27details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

Product attributes reference data we hold

Active ingredient (INN)	Bicalutamide
Brand names	Bicalox, Casodex, Bicalutamida Stada, CALUTEX bicalutamide
ATC level 5	L02BB03
ATC level 4	L02BB
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	BRISTOL LABORATORIES LIMITED, ACCORD HEALTHCARE LIMITED, RELONCHEM LIMITED, TORRENT PHARMA (UK) LTD +4 more
Registrations on file	18
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$36.35

AEMP

Dispensed (DPMQ)

A$52.27

incl. fees

Pack

bicalutamide 50 mg tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£4.77

concession

🇺🇸 US

US$0.42

Acquisition

🇮🇹 IT

€130.68

Retail price

🇫🇷 FR

€53.92

Retail price

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

9 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

Excella GMBH And CO KgTapi Nl BVHetero Labs LTDOlon SPASun Pharmaceutical Industries LTDAarti Pharmalabs LTD+3 more

Manufacturing countries: Germany, India, Italy, Spain · Source: FDA List of Drug Master Files

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders18 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
BICALUTAMIDE 50 MG FILM-COATED TABLETS	50 MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
BICALUTAMIDE 150 MG FILM-COATED TABLETS	150 MG	tablet	🇬🇧 GB	BRISTOL LABORATORIES LIMITED	Active
BICALUTAMIDE 50MG FILM-COATED TABLETS	50MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
BICALUTAMIDE 150MG FILM-COATED TABLETS	150MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
BICALUTAMIDE 50MG FILM COATED TABLETS	50MG	tablet	🇬🇧 GB	RELONCHEM LIMITED	Active
BICALUTAMIDE 150MG FILM COATED TABLETS	150MG	tablet	🇬🇧 GB	RELONCHEM LIMITED	Active
BICALUTAMIDE 50MG TABLETS	50MG	tablet	🇬🇧 GB	TORRENT PHARMA (UK) LTD	Active
COSUDEX bicalutamide	50 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
Cosamide	50mg	—	🇦🇺 AU	Alphapharm Pty Ltd	Active
COSUDEX bicalutamide	150 mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
ZolaCos CP combination Goserelin	3.6mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
ZolaCos CP combination Goserelin	10.8mg	—	🇦🇺 AU	AstraZeneca Pty Ltd	Active
COSAMIDE bicalutamide	50mg	tabfc	🇦🇺 AU	Alphapharm Pty Ltd	Active
BICALOX bicalutamide	50mg	—	🇦🇺 AU	—	Active
Scp	50 mg	—	🇦🇺 AU	Southern Cross Pharma Pty Ltd	Active

+3 more registrations on file

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.