Dapsone shortage — US supply status & alternatives

Dapsone

ATC D10AX05

🇦🇺 AUST R 17608

Anticipated · Australia

Dapson ZentivaLink Medical Products

Anticipated · 🇦🇺 Australia & also short in🇺🇸 US🇩🇪 DE🇳🇴 NO

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$283.44DPMQ A$319.77details →

✓ Can I substitute?

Yes — under S19A

TGA s19A · dapsone-tablets-usp-25mg-rising-pharmaceuticals-usa

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Dec 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Dapsone
Brand names	Dapson Zentiva, Link Medical Products
ATC level 5	D10AX05
ATC level 4	D10AX
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	ACCORD-UK LIMITED, ACTAVIS GROUP PTC EHF, TILLOMED LABORATORIES LIMITED, MORNINGSIDE HEALTHCARE LIMITED +6 more
Registrations on file	15
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$283.44

AEMP

Dispensed (DPMQ)

A$319.77

incl. fees

Pack

Dapsone 50 mg tablet, 100

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.70

Acquisition

Substitution pathways 🇦🇺 Australia · TGA

✓

Section 19A approval in force · dapsone-tablets-usp-25mg-rising-pharmaceuticals-usa

TGA Section 19A: overseas-registered 'Dapsone Tablets, USP 25mg (Rising Pharmaceuticals, USA)' approved for import and supply in Australia during a shortage. Origin: Rising Pharmaceuticals, USA. Expires Feb 2027. Verify on TGA Section 19A approvals ↗

How long have past shortages lasted? from 1 resolved event

◷

~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

11 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

Lundbeck Pharmaceuticals Italy SPAAtul LTDSai Life Sciences LTDNovitium Pharma LLCTaro Pharmaceutical Industries LTDDipharma Francis Srl+5 more

Manufacturing countries: Italy, India, United States, Israel, China · Source: FDA List of Drug Master Files

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Apr 2025

Latest approval

Shortage status by regulator official notices

🇺🇸

United States

FDA MedWatch · 1d ago

High

🇦🇺

Australia

TGA · just now

Medium

🇩🇪

Germany

BfArM · 10d ago

Medium

🇳🇴

Norway

NOMA · 1mo ago

Medium

Recalls official enforcement reports

🇺🇸

DAPSONE

VIONA PHARMACEUTICALS INC · Dec 2024

Class IIdetails ↗

🇺🇸

DAPSONE

VIONA PHARMACEUTICALS INC · Dec 2024

Class IIdetails ↗

🇺🇸

DAPSONE

VIONA PHARMACEUTICALS INC · Oct 2024

Class IIdetails ↗

🇺🇸

DAPSONE

VIONA PHARMACEUTICALS INC · Sept 2024

Class IIdetails ↗

🇺🇸

Dapsone Active Pharmaceutical Ingredient Packaged In Varying

Attix Pharmaceuticals · Nov 2014

Class IIdetails ↗

Verified timeline regulator events

🇦🇺 1 Sept 2026

medium reported

🇦🇺 14 Aug 2026

low reported

🇦🇺 7 Aug 2026

medium reported

🇦🇺 15 July 2026

low reported

🇦🇺 30 May 2026

Shortage resolved

🇺🇸 27 Mar 2026

medium reported

Sources official regulators

🇺🇸

FDA

verified just now

verify ↗

🇦🇺

TGA

verified just now

verify ↗

🇺🇸

FDA MedWatch

verified 1d ago

verify ↗

🇩🇪

BfArM

verified 10d ago

verify ↗

🇳🇴

NOMA

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders15 registrations · 10 MA holders

Product	Strength	Form	Market	MA holder	Status
Dapsone Tablets Bp	50MG	tablet	🇬🇧 GB	ACCORD-UK LIMITED	Active
Dapsone Tablets Bp	100MG	tablet	🇬🇧 GB	ACTAVIS GROUP PTC EHF	Active
DAPSONE 50MG TABLETS	50MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
DAPSONE 100MG TABLETS	100MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
DAPSONE 50 MG TABLETS	50 MG	tablet	🇬🇧 GB	MORNINGSIDE HEALTHCARE LIMITED	Active
DAPSONE 100 MG TABLETS	100 MG	tablet	🇬🇧 GB	MORNINGSIDE HEALTHCARE LIMITED	Active
DAPSONE 25MG TABLETS	25MG	tablet	🇬🇧 GB	MACLEODS PHARMA UK LIMITED	Active
Alphapharm Dapsone	100mg	tabuc	🇦🇺 AU	—	Active
Link Medical Products	25mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
Link Medical Products	100mg	—	🇦🇺 AU	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Active
ACZONE dapsone 7.5% w/w topical gel bottle	7.5%	—	🇦🇺 AU	Abbvie Pty Ltd	Active
Dapsone	75mg/g	gel	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
DAPSONE	50mg/g	gel	🇺🇸 US	COSETTE PHARMACEUTICALS, INC.	Active
Dapsone	25mg/1	tablet	🇺🇸 US	Seton Pharmaceuticals	Discontinued
Dapsone	100mg/1	tablet	🇺🇸 US	Seton Pharmaceuticals	Discontinued

Mederti Drug Report

Generated 1 July 2026 · Australia market · 5 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.