Raltegravir — supply status, manufacturers & alternatives

Raltegravir

—

🇦🇺 AUST R 140238 · Merck Sharp & Dohme Australia Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia · short in🌐 CO

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$420.52details →

✓ 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 reference data we hold

Active ingredient (INN)	Raltegravir
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper

Marketing-authorisation holders	Merck Sharp & Dohme Australia Pty Ltd, Viatris Limited

Registrations on file	5

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$420.52

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

raltegravir 400 mg tablet, 60

Source: PBSEffective July 2026 · AUD

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

7 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

Maithri Drugs Private LTDMatrix Pharmacorp Private LTDLupin Manufacturing Solutions LTDHetero Drugs LTDLee Pharma LTDApitoria Pharma Private LTD+1 more

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders5 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
ISENTRESS raltegravir	400 mg	—	🇦🇺 AU	Merck Sharp & Dohme Australia Pty Ltd	Active
ISENTRESS raltegravir	100 mg	—	🇦🇺 AU	Merck Sharp & Dohme Australia Pty Ltd	Active
ISENTRESS raltegravir	25 mg	—	🇦🇺 AU	Merck Sharp & Dohme Australia Pty Ltd	Active
ISENTRESS HD raltegravir	600 mg	—	🇦🇺 AU	Merck Sharp & Dohme Australia Pty Ltd	Active
Raltegravir Viatris	—	—	🌐 EU	Viatris Limited	Application withdrawn

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.