Donepezil shortage — BE supply status & alternatives

Donepezil

ATC N06DA02

🇦🇺 AUST R 231658 · Cipla Australia Pty Ltd

In supply · Australia

AriceptAridon ApnDonepezil SandozDonepezilo Viatris

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇧🇪 BE🇬🇷 GR🌐 MY

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$4.10DPMQ A$18.70details →

✓ 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

Active ingredient (INN)	Donepezil
Brand names	Aricept, Aridon Apn, Donepezil Sandoz, Donepezilo Viatris
ATC level 5	N06DA02
ATC level 4	N06DA
Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, ROSEMONT PHARMACEUTICALS LIMITED, Cipla Australia Pty Ltd, SANDOZ LIMITED +2 more
Registrations on file	11
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$4.10

AEMP

Dispensed (DPMQ)

A$18.70

incl. fees

Pack

donepezil hydrochloride 10 mg tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£1.10

Drug Tariff

🇺🇸 US

US$0.05

Acquisition

🇫🇷 FR

€22.94

Retail price

🇮🇹 IT

€13.00

Retail price

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

3 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.

High concentration risk

Macleods Pharmaceuticals LTDPerrigo Api LTDNeuland Laboratories LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders11 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
Donepezil Hydrochloride	5 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Donepezil Hydrochloride	10 MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Donepezil Hydrochloride	1MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
CIPLA DONEPEZIL donepezil hydrochloride	5 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
CIPLA DONEPEZIL donepezil hydrochloride	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
DONEPEZIL 5 MG ORODISPERSIBLE TABLETS	5 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
DONEPEZIL 10 MG ORODISPERSIBLE TABLETS	10 MG	tablet	🇬🇧 GB	SANDOZ LIMITED	Active
Donepezil Hydrochloride	5MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Donepezil Hydrochloride	10MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
DONEPEZIL 5MG FILM COATED TABLETS	5MG	tablet	🇬🇧 GB	IPCA LABORATORIES UK LIMITED	Active
DONEPEZIL 10MG FILM COATED TABLETS	10MG	tablet	🇬🇧 GB	IPCA LABORATORIES UK LIMITED	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.