Brimonidine Tartrate shortage — CA supply status & alternatives

Brimonidine Tartrate

ATC D11AX21

🇦🇺 AUST R 60297 · Abbvie Pty Ltd

In supply · Australia

Brimofree®

In supply · 🇦🇺 Australia · short in🇨🇦 CA

In supply in Australia

Reading today’s signals…

✓ 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 reference data we hold

ATC level 4
Active ingredient (INN)	Brimonidine Tartrate
Brand names	Brimofree®
ATC level 5	D11AX21

Therapeutic category	Auto-created by National Organisation for Medicines — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	Generics (UK) Limited, STRANDHAVEN LIMITED, FDC INTERNATIONAL LIMITED, CRESCENT PHARMA LIMITED +8 more

Registrations on file	19

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

—

Dispensed (DPMQ)

—

Pack

—

Not yet captured for Australia

Official pricing isn’t on file for this market yet. PBS (Australia), NHS Drug Tariff (United Kingdom) and CMS NADAC (United States) feeds are prioritised; this panel populates automatically once the data lands.

Other markets

🇺🇸 US

US$12.28

Acquisition

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

12 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

Micro Labs LTDSiegfried Grafton INCCentaur Pharmaceuticals PVT LTDMaithri Drugs Private LTDFarmak AsMedichem SA+6 more

Manufacturing countries: India, United States, Spain · Source: FDA List of Drug Master Files

Recalls official enforcement reports

🇺🇸

BRIMONIDINE TARTRATE

Apotex Corp. · Mar 2023

Class IIdetails ↗

🇺🇸

BRIMONIDINE TARTRATE

SOMERSET THERAPEUTICS LLC · June 2020

Class IIIdetails ↗

🇺🇸

BRIMONIDINE TARTRATE

SOMERSET THERAPEUTICS LLC · June 2020

Class IIIdetails ↗

🇺🇸

BRIMONIDINE TARTRATE

SOMERSET THERAPEUTICS LLC · June 2020

Class IIIdetails ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders19 registrations · 12 MA holders

Product	Strength	Form	Market	MA holder	Status
BRIMONIDINE TARTRATE 2 MG/ML EYE DROPS, SOLUTION	2 MG	solution	🇬🇧 GB	Generics (UK) Limited	Active
Brimonidine Tartrate/Timolol	2 MG	solution	🇬🇧 GB	Generics (UK) Limited	Active
BRIMONIDINE TARTRATE 2MG/ML EYE DROPS SOLUTION	2MG	solution	🇬🇧 GB	STRANDHAVEN LIMITED	Active
Brimonidine Tartrate 0.2% W/V Eye Drops	0.2%	drops	🇬🇧 GB	FDC INTERNATIONAL LIMITED	Active
BRIMONIDINE TARTRATE 2 MG/ML, EYE DROPS, SOLUTION	2 MG	solution	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Brimonidine Tartrate 0.2% W/V Eye Drops	0.2%	solution	🇬🇧 GB	BROWN & BURK UK LIMITED	Active
ALPHAGAN brimonidine tartrate	2mg	—	🇦🇺 AU	Abbvie Pty Ltd	Active
ENIDIN brimonidine tartrate	2mg	—	🇦🇺 AU	Abbvie Pty Ltd	Active
COMBIGAN brimonidine tartrate	2.0mg	—	🇦🇺 AU	Abbvie Pty Ltd	Active
Alphagan P	0.15%	—	🇦🇺 AU	Abbvie Pty Ltd	Active
Enidin P	0.15%	—	🇦🇺 AU	Abbvie Pty Ltd	Active
SIMBRINZA 1%/0.2% brinzolamide 1% and brimonidine tartrate 0.2% eye drops suspension bottle	1%	—	🇦🇺 AU	Novartis Pharmaceuticals Australia Pty Ltd	Active
Brimonidine Tartrate and Timolol Maleate	2; 5mg/mL; mg/mL	solution	🇺🇸 US	SANDOZ INC	Active
Brimonidine Tartrate	2mg/mg	solution	🇺🇸 US	Indoco Remedies Limited	Active
Brimonidine Tartrate	2mg/mL	solution	🇺🇸 US	Bausch & Lomb Incorporated	Active

+4 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.