Apremilast shortage — CA supply status & alternatives

Apremilast

ATC L04AA32

🇦🇺 AUST R 220423 · Amgen Australia Pty Ltd

In supply · Australia

Gln-ApremilastApremilast TevaApremilast Accord

In supply · 🇦🇺 Australia · short in🇨🇦 CA🇪🇸 ES🇮🇹 IT

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$223.16DPMQ A$253.76details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

Product attributes reference data we hold

Active ingredient (INN)	Apremilast
Brand names	Gln-Apremilast, Apremilast Teva, Apremilast Accord
ATC level 5	L04AA32
ATC level 4	L04AA
Therapeutic category	Auto-created by Health Canada — Drug Shortages Database scraper
Controlled substance	No
Marketing-authorisation holders	Amgen Australia Pty Ltd, Accord Healthcare S.L.U., Viatris Limited, GLENMARK PHARMACEUTICALS CANADA INC. +8 more
Registrations on file	13
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$223.16

AEMP

Dispensed (DPMQ)

A$253.76

incl. fees

Pack

apremilast 10 mg tablet [4] (&) apremilast 20 mg tablet [4] (&) apremilast 30 mg tablet [19], 27

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$90.48

Acquisition

🇮🇹 IT

€301.63

Retail price

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

27 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

Zaklady Farmaceutyczne Polpharma SAMegafine Pharma P LTDSun Pharmaceutical Industries LTDLupin Manufacturing Solutions LTDMsn Life Sciences Private LTDDr Reddys Laboratories LTD+21 more

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

Verified timeline regulator events

🇨🇦 22 June 2026

high reported

🇮🇹 5 June 2026

medium reported

🇪🇸 7 May 2026

medium reported

🇨🇦 5 May 2026

high reported

🇪🇸 27 Apr 2026

medium reported

🇨🇦 9 Dec 2025

high reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders13 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
OTEZLA apremilast	30 mg	—	🇦🇺 AU	Amgen Australia Pty Ltd	Active
OTEZLA TITRATION PACK apremilast tablet blister pack	—	—	🇦🇺 AU	Amgen Australia Pty Ltd	Active
Apremilast Accord	—	—	🌐 EU	Accord Healthcare S.L.U.	Active
Apremilast Viatris	—	—	🌐 EU	Viatris Limited	Application withdrawn
Gln-Apremilast	—	tablet	🇨🇦 CA	GLENMARK PHARMACEUTICALS CANADA INC.	Active
Pms-Apremilast	—	tablet	🇨🇦 CA	PHARMASCIENCE INC	Active
Auro-Apremilast	—	tablet	🇨🇦 CA	AURO PHARMA INC	Active
Jamp Apremilast	—	tablet	🇨🇦 CA	JAMP PHARMA CORPORATION	Active
Sandoz Apremilast	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	Active
Apo-Apremilast	—	tablet	🇨🇦 CA	APOTEX INC	Active
Mar-Apremilast	—	tablet	🇨🇦 CA	MARCAN PHARMACEUTICALS INC	Active
Teva-Apremilast	—	tablet	🇨🇦 CA	TEVA CANADA LIMITED	Active
Mint-Apremilast	—	tablet	🇨🇦 CA	MINT PHARMACEUTICALS INC	Dormant

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.