Lenalidomide shortage — IT supply status & alternatives

Lenalidomide

ATC L04AX04

🇦🇺 AUST R 307068 · Cipla Australia Pty Ltd

In supply · Australia

Kleder

In supply · 🇦🇺 Australia · short in🇮🇹 IT🇨🇦 CA🇧🇪 BE🇬🇷 GR🇮🇪 IE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$248.50details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Adalimumab

◷ Expected back

No estimate

No estimate provided

Product attributes

reference data we hold

Active ingredient (INN)	Lenalidomide
Brand names	Kleder
ATC level 5	L04AX04
ATC level 4	L04AX
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper
Controlled substance	No
Marketing-authorisation holders	Cipla Australia Pty Ltd, Dr Reddys Laboratories Australia Pty Ltd, Teva Pharma Australia Pty Ltd, Juno Pharmaceuticals Pty Ltd
Registrations on file	30
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$248.50

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

lenalidomide 5 mg capsule, 21

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.

How long have past shortages lasted? from 2 resolved events

◷

1–2 months

Historical pattern from resolved shortage records — not a prediction of this event.

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

20 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

Msn Laboratories Private LTDApitoria Pharma Private LTDShilpa Pharma Lifesciences LTDHetero Labs LTDMatrix Pharmacorp Private LTDZydus Lifesciences LTD+14 more

Manufacturing countries: India, China, Malaysia, South, Turkey, United States · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Feb 2024

Latest approval

Shortage status by regulator official notices

🇮🇹

Italy

AIFA · 7h ago

Critical

🇨🇦

Canada

HC · just now

High

🇬🇷

EOF · 1h ago

Medium

🇧🇪

FAMHP · 1h ago

Medium

🇮🇪

Ireland

HPRA · 4h ago

Medium

Recalls official enforcement reports

🌐

Lenalidomide Krka d.d.

Krka, d.d., Novo mesto · Dec 2021

Class Unifieddetails ↗

Verified timeline regulator events

🇮🇹 1 Aug 2026

Shortage resolved

🇮🇹 28 July 2026

critical reported

🇧🇪 5 June 2026

medium reported

🇮🇪 1 June 2026

medium reported

🇮🇹 15 May 2026

critical reported

🇮🇹 8 May 2026

critical reported

Sources official regulators

🇨🇦

verified just now

verify ↗

🇬🇷

EOF

verified 1h ago

verify ↗

🇧🇪

FAMHP

verified 1h ago

verify ↗

🇮🇪

HPRA

verified 4h ago

verify ↗

🇮🇹

AIFA

verified 6h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
LENALIMID lenalidomide	15 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALIMID lenalidomide	20 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALIMID lenalidomide	25 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALICIP lenalidomide	5 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALICIP lenalidomide	15 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALICIP lenalidomide	20 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALICIP lenalidomide	25 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Cipla	5 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALICIP lenalidomide	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Cipla	10 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Cipla	15 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Cipla	20 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Cipla	25 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
LENALIMID lenalidomide	5 mg	—	🇦🇺 AU	Cipla Australia Pty Ltd	Active
Dr.Reddy'S	15 mg	—	🇦🇺 AU	Dr Reddys Laboratories Australia Pty Ltd	Active

+15 more registrations on file

Mederti Drug Report

Generated 1 July 2026 · Australia market · 5 regulatory sources

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.