Topiramate shortage — AU supply status & alternatives

Topiramate

ATC N03AX11

In shortage · Australia

Epiramax

In declared shortage · 🇦🇺 Australia & also short in🌐 EU🇨🇦 CA🇺🇸 US🇧🇪 BE🌐 MY

Critical shortage

Reading today’s signals…

🇦🇺 AUAEMPA$4.00DPMQ A$22.84details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Topiramato

◷ Expected back

Dec 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Topiramate
Brand names	Epiramax
ATC level 5	N03AX11
ATC level 4	N03AX
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	ROSEMONT PHARMACEUTICALS LIMITED, Generics (UK) Limited, MILPHARM LIMITED, ACCORD HEALTHCARE LIMITED +4 more
Registrations on file	30
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$4.00

AEMP

Dispensed (DPMQ)

A$22.84

incl. fees

Pack

topiramate 25 mg tablet, 60

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.03

Acquisition

🇬🇧 GB

£1.46

Drug Tariff

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.

How long have past shortages lasted? from 3 resolved events

◷

2–7 months

Historical pattern from resolved shortage records — not a prediction of this event.

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

18 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 NVApitoria Pharma Private LTDGlobal Calcium Private LTDCipla LTDDr Reddys Laboratories LTDScinopharm Taiwan LTD+12 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Oct 2025

Latest approval

Shortage status by regulator official notices

🇦🇺

Australia

TGA · 2h ago

Critical

🌐

EMA · 1d ago

High

🇨🇦

Canada

HC · 2h ago

Medium

🇺🇸

United States

FDA · 2h ago

Medium

🌐

NPRA · 3h ago

Medium

🇧🇪

FAMHP · 4h ago

Medium

Recalls official enforcement reports

🇦🇺

Topiramate Powder 25g & 100gLot Number: 197735Expiry Date: 31/01/2026ARTG not on the register

Medisca Australia Pty Ltd · May 2025

Class IIIdetails ↗

🇺🇸

EPRONTIA

Azurity Pharmaceuticals, Inc. · Dec 2023

Class IIIdetails ↗

🇺🇸

TOPIRAMATE

UNICHEM PHARMACEUTICALS USA INC · Oct 2021

Class IIIdetails ↗

🇺🇸

TROKENDI XR

Cardinal Health Inc. · Mar 2021

Class IIdetails ↗

🇺🇸

Topiramate

Calvin Scott & Company, Inc. · July 2020

Class IIdetails ↗

🇺🇸

TROKENDI XR

Supernus Pharmaceuticals, Inc. · July 2016

Class IIdetails ↗

Verified timeline regulator events

🇦🇺 9 Oct 2026

low reported

🇦🇺 2 Oct 2026

low reported

🇦🇺 28 Aug 2026

low reported

🇦🇺 20 July 2026

low reported

🇦🇺 10 July 2026

low reported

🇦🇺 29 June 2026

low reported

Sources official regulators

🇨🇦

verified 2h ago

verify ↗

🇺🇸

FDA

verified 2h ago

verify ↗

🇦🇺

TGA

verified 2h ago

verify ↗

🌐

NPRA

verified 3h ago

verify ↗

🇧🇪

FAMHP

verified 4h ago

verify ↗

🌐

EMA

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders30 registrations · 8 MA holders

Product	Strength	Form	Market	MA holder	Status
Topiramate Rosemont	10MG	suspension	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Topiramate Rosemont	20MG	suspension	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Topiramate Mylan	25 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Topiramate Mylan	50 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Topiramate Mylan	100 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Topiramate Mylan	200 MG	tablet	🇬🇧 GB	Generics (UK) Limited	Active
Topiramate Milpharm	25 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Topiramate Milpharm	50 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Topiramate Milpharm	100 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Topiramate Milpharm	200 MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
Topiramate Accord	25 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Topiramate Accord	50 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Topiramate Accord	100 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Topiramate Accord	200 MG	tablet	🇬🇧 GB	ACCORD HEALTHCARE LIMITED	Active
Topiramate Morningside	25 MG	tablet	🇬🇧 GB	MORNINGSIDE HEALTHCARE LIMITED	Active

+15 more registrations on file

Mederti Drug Report

Generated 1 July 2026 · Australia market · 6 regulatory sources

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.