Riociguat shortage — AU supply status & alternatives

Riociguat

—

🇦🇺 AUST R 207599 · Bayer Australia Ltd

In shortage · Australia

Adempas

In declared shortage · 🇦🇺 Australia

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$1631.82details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

July 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Riociguat
Brand names	Adempas

Therapeutic category	Auto-created by Agenzia Italiana del Farmaco — Carenze scraper

Controlled substance	No

Marketing-authorisation holders	Bayer Australia Ltd, SANDOZ CANADA INCORPORATED

Registrations on file	6

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$1631.82

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

riociguat 1.5 mg tablet, 42

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.

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

5 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

Biophore India Pharmaceuticals PVT LTDMsn Life Sciences Private LTDAlembic Pharmaceuticals LTDHonour Lab LTDZhejiang Kingland Pharmaceutical CO LTD

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

Verified timeline regulator events

🇦🇺 25 June 2026

high reported

🇮🇹 24 Nov 2022

Shortage resolved

🇮🇹 23 Aug 2022

Shortage resolved

🇮🇹 4 Aug 2022

Shortage resolved

🇮🇹 22 July 2022

Shortage resolved

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders6 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
ADEMPAS riociguat	1 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
ADEMPAS riociguat	0.5 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
ADEMPAS riociguat	2.5 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
ADEMPAS riociguat	1.5 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
ADEMPAS riociguat	2 mg	—	🇦🇺 AU	Bayer Australia Ltd	Active
Sandoz Riociguat	—	tablet	🇨🇦 CA	SANDOZ CANADA INCORPORATED	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.