Lorlatinib shortage — US supply status & alternatives

Lorlatinib

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🇦🇺 AUST R 310781 · Pfizer Australia Pty Ltd

In supply · Australia

Lorbrena

In supply · 🇦🇺 Australia · short in🇺🇸 US

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$6272.46DPMQ A$6530.27details →

✓ 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

Brand names
Active ingredient (INN)	Lorlatinib

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Pfizer Australia Pty Ltd

Registrations on file	2

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$6272.46

AEMP

Dispensed (DPMQ)

A$6530.27

incl. fees

Pack

lorlatinib 100 mg tablet, 30

Source: PBSEffective July 2026 · AUD

Substitution pathways 🇦🇺 Australia · TGA

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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

1 API manufacturer

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.

Very high concentration risk

Sun Pharmaceutical Industries LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
LORVIQUA lorlatinib	25 mg	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
LORVIQUA lorlatinib	100 mg	—	🇦🇺 AU	Pfizer Australia 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.