Buprenorphine shortage — AU supply status & alternatives

Buprenorphine

—

🇦🇺 AUST R 294997

In shortage · Australia

BelbucaBuprenorphin AWD MatrixBuprenorphine HydrochlorideTEMGESIC buprenorphine 300microgram/

In declared shortage · 🇦🇺 Australia & also short in🇮🇳 IN

Critical shortage

Product discontinued / no longer available on the Australian market.

Reading today’s signals…

🇦🇺 AUAEMPA$4.98details →

✓ 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

Active ingredient (INN)	Buprenorphine
Brand names	Belbuca, Buprenorphin AWD Matrix, Buprenorphine Hydrochloride, TEMGESIC buprenorphine 300microgram/
Therapeutic category	Auto-created by FDA Drug Enforcement — Full Recall Database scraper
Controlled substance	No
Marketing-authorisation holders	Mundipharma Pty Ltd, AU Pharma Pty Ltd, Indivior Pty Ltd, ACCORD-UK LIMITED +2 more
Registrations on file	28
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$4.98

AEMP

Dispensed (DPMQ)

—

incl. fees

Pack

buprenorphine 400 microgram sublingual tablet, 7

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£2.60

Drug Tariff

🇫🇷 FR

€9.69

Retail price

🇺🇸 US

US$22.80

Acquisition

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

10 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

Noramco LLCSpecgx LLCIndivior Uk LTDSiegfried LTDMacfarlan Smith LTD A Johnson Matthey COArevipharma GMBH+4 more

Manufacturing countries: United States, United Kingdom, Switzerland, Germany, India, Denmark · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🌐

Sixmo

L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. · June 2025

Class Unifieddetails ↗

🇺🇸

BUPRENORPHINE

SUN PHARMACEUTICAL INDUSTRIES INC · May 2023

Class IIdetails ↗

🇺🇸

BUPRENORPHINE

Teva Pharmaceuticals USA · Sept 2020

Class IIdetails ↗

🇺🇸

Buprenorphine

Pharmacy Plus, Inc. dba Vital Care Compounder · July 2016

Class IIdetails ↗

🇺🇸

Buprenorphine

Beacon Hill Medical Pharmacy, P.C. · July 2013

Class IIdetails ↗

🇺🇸

Buprenorphine

Lowlite Investments, Inc. D/B/A Olympia Pharmacy · May 2013

Class IIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders28 registrations · 6 MA holders

Product	Strength	Form	Market	MA holder	Status
BUVIDAL WEEKLY buprenorphine	8 mg	—	🇦🇺 AU	—	Active
BUVIDAL MONTHLY buprenorphine	160 mg	—	🇦🇺 AU	—	Active
NORSPAN buprenorphine	5 microgram	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
Aup	10 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
B-PATCH buprenorphine	10 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
B-PATCH buprenorphine	5 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Aup	15 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Aup	20 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Aup	5 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
B-PATCH buprenorphine	20 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
BUPRADEX buprenorphine	0.4mg	—	🇦🇺 AU	Indivior Pty Ltd	Active
BUPRADEX buprenorphine	2mg	—	🇦🇺 AU	Indivior Pty Ltd	Active
BUPRADEX buprenorphine	8mg	—	🇦🇺 AU	Indivior Pty Ltd	Active
B-PATCH buprenorphine	15 microgram	—	🇦🇺 AU	AU Pharma Pty Ltd	Active
Suboxone	2 mg	—	🇦🇺 AU	Indivior Pty Ltd	Active

+13 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.