Paliperidone shortage — IT supply status & alternatives

Paliperidone

ATC N05AX13

🇦🇺 AUST R 354090 · Janssen-Cilag Pty Ltd

In supply · Australia

Invega

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$39.09DPMQ A$55.13details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Risperidone

◷ Expected back

Product attributes reference data we hold

Active ingredient (INN)	Paliperidone
Brand names	Invega
ATC level 5	N05AX13
ATC level 4	N05AX
Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper
Controlled substance	No
Marketing-authorisation holders	Janssen-Cilag Pty Ltd, Teva Pharma Australia Pty Ltd, MAJOR PHARMACEUTICALS, NORTHSTAR RXLLC
Registrations on file	24
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$39.09

AEMP

Dispensed (DPMQ)

A$55.13

incl. fees

Pack

paliperidone 3 mg modified release tablet, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇮🇹 IT

€133.47

Retail price

🇺🇸 US

US$0.87

Acquisition

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

28 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

Janssen Pharmaceutica NVApotex INCJubilant Biosys LTDUnimark Remedies LTDMatrix Pharmacorp Private LTDPh Health LTD+22 more

Manufacturing countries: Belgium, Canada, India, Malta, China, Greece · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

PALIPERIDONE

The Harvard Drug Group · Feb 2022

Class IIdetails ↗

🇺🇸

Paliperidone Extended Release Tablets

Teva Pharmaceuticals USA · Aug 2018

Class IIdetails ↗

🇺🇸

Paliperidone Extended Release Tablets

Teva Pharmaceuticals USA · Aug 2018

Class IIdetails ↗

🇺🇸

Paliperidone Extended-Release Tablets

Teva Pharmaceuticals · May 2017

Class Idetails ↗

🇺🇸

Paliperidone Extended-Release Tablets

Mylan Pharmaceuticals Inc. · Feb 2016

Class IIdetails ↗

Verified timeline regulator events

🇮🇹 30 June 2026

medium reported

🇧🇪 23 June 2026

medium reported

🇬🇷 14 May 2026

medium reported

🇮🇹 16 Mar 2026

critical reported

🇮🇹 10 Mar 2026

Shortage resolved

🇮🇹 2 Mar 2026

critical reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders24 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
INVEGA HAFYERA paliperidone	1000 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA HAFYERA paliperidone	700 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
Teva	150 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	50 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	100 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	25 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
Teva	75 mg	—	🇦🇺 AU	Teva Pharma Australia Pty Ltd	Active
INVEGA SUSTENNA paliperidone	50 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA SUSTENNA paliperidone	150 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA SUSTENNA paliperidone	25 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA SUSTENNA paliperidone	75 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA SUSTENNA paliperidone	100 mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA paliperidone	3mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA paliperidone	6mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active
INVEGA paliperidone	9mg	—	🇦🇺 AU	Janssen-Cilag Pty Ltd	Active

+9 more registrations on file

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.