Nicotine shortage — BE supply status & alternatives

Nicotine

—

🇦🇺 AUST R 339412 · Orion Laboratories Pty Ltd T/A Perrigo Australia

In supply · Australia

Nicorette Freshmint

In supply · 🇦🇺 Australia · short in🇺🇸 US🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$35.23DPMQ A$51.10details →

✓ Can I substitute?

In supply

no shortage substitution needed

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Nicotine

Brand names	Nicorette Freshmint

Therapeutic category	Auto-created by Federal Agency for Medicines and Health Products — PharmaStatus scraper

Controlled substance	No

Marketing-authorisation holders	Orion Laboratories Pty Ltd T/A Perrigo Australia, Johnson & Johnson Pacific Pty Ltd, GlaxoSmithKline Consumer Healthcare Australia Pty Ltd, DR REDDY'S LABORATORIES (UK) LIMITED

Registrations on file	29

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$35.23

AEMP

Dispensed (DPMQ)

A$51.10

incl. fees

Pack

nicotine 25 mg/16 hours patch, 28

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$0.28

Acquisition

🇬🇧 GB

£13.57

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 6 resolved events

◷

0–3 months

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

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

13 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

Cambrex Charles City INCSiegfried LTDNicobrand LTDBgp Healthcare Private LTDPorton Fine Chemicals LTDKenvue Brands LLC+7 more

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

Shortage status by regulator official notices

🌐

IMA · 12h ago

Resolved

🇺🇸

United States

FDA MedWatch · 1d ago

Medium

🇧🇪

FAMHP · 1d ago

Medium

Recalls official enforcement reports

🇨🇦

Nicotine Pouch

Drugs and health products · June 2026

Class IIdetails ↗

🇺🇸

NICOTINE

AVEVA Drug Delivery Systems, Inc. · May 2026

Class IIIdetails ↗

🇨🇦

Nicotine pouches (placed in the mouth between the gum and cheek

Communications and Public Affairs Branch · Aug 2025

Class ?details ↗

🇨🇦

Nicotine pouches (placed in the mouth between the gum and cheek

Communications and Public Affairs Branch · Aug 2025

Class ?details ↗

Verified timeline regulator events

🌐 25 June 2026

Shortage resolved

🌐 10 June 2026

Shortage resolved

🌐 27 May 2026

Shortage resolved

🇧🇪 20 May 2026

medium reported

🇺🇸 14 May 2026

medium reported

🌐 19 Apr 2026

Shortage resolved

Sources official regulators

🌐

IMA

verified 12h ago

verify ↗

🇺🇸

FDA MedWatch

verified 1d ago

verify ↗

🇧🇪

FAMHP

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders29 registrations · 4 MA holders

Product	Strength	Form	Market	MA holder	Status
Herron Nicaway Mini Lozenge Mint	4 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Herron Nicaway Step	52.5mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
Herron Nicaway Step	35mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICORETTE nicotine	2 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICORETTE nicotine	4 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICABATE nicotine	2mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
NICABATE nicotine	4mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
NICORETTE QUICKMIST SMARTTRACK nicotine	1 mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active
NICOTINELL MINT CHEWING GUM Nicotine	4mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICOTINELL MINI LOZENGES nicotine	2 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICOTINELL MINI LOZENGE nicotine	4 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICABATE MINI LOZENGES nicotine	4 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
NICABATE MINI LOZENGES nicotine	2 mg	—	🇦🇺 AU	GlaxoSmithKline Consumer Healthcare Australia Pty Ltd	Active
HERRON NICAWAY LOZENGES, nicotine	2 mg	—	🇦🇺 AU	Orion Laboratories Pty Ltd T/A Perrigo Australia	Active
NICORETTE COOLDROPS nicotine	2mg	—	🇦🇺 AU	Johnson & Johnson Pacific Pty Ltd	Active

+14 more registrations on file

Mederti Drug Report

Generated 3 July 2026 · Australia market · 3 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.