Cabotegravir — supply status, manufacturers & alternatives

Cabotegravir

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🇦🇺 AUST R 323721 · ViiV Healthcare Pty Ltd

In supply · Australia

In supply · 🇦🇺 Australia

In supply in Australia

No active shortage reported.

Reading today’s signals…

✓ 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)	Cabotegravir
Therapeutic category	Auto-created by INVIMA — Desabastecimiento de medicamentos (Colombia) scraper
Controlled substance	No
Marketing-authorisation holders	ViiV Healthcare Pty Ltd

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

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.

How long have past shortages lasted? from 1 resolved event

◷

~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

4 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.

Moderate concentration risk✓ 1 WHO-prequalified

Matrix Pharmacorp Private LTDShanghai Desano Chemical Pharmaceutical Co., Ltd.Cipla LTDApitoria Pharma Private LTD

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Dec 2023

Latest approval

Shortage status by regulator official notices

🌐

INVIMA · 22h ago

Resolved

Verified timeline regulator events

🌐 1 May 2026

Shortage resolved

Sources official regulators

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INVIMA

verified 22h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders5 registrations · 1 MA holder

Product	Strength	Form	Market	MA holder	Status
VOCABRIA cabotegravir	30 mg	—	🇦🇺 AU	ViiV Healthcare Pty Ltd	Active
CABENUVA cabotegravir	400 mg	—	🇦🇺 AU	ViiV Healthcare Pty Ltd	Active
CABENUVA cabotegravir	600 mg	—	🇦🇺 AU	ViiV Healthcare Pty Ltd	Active
APRETUDE cabotegravir	30 mg	—	🇦🇺 AU	ViiV Healthcare Pty Ltd	Active
APRETUDE cabotegravir	600 mg	—	🇦🇺 AU	ViiV Healthcare Pty Ltd	Active

Mederti Drug Report

Generated 4 July 2026 · Australia market · 1 regulatory source

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.