Ethinylestradiol shortage — BE supply status & alternatives

Ethinylestradiol

ATC G03CA01

🇦🇺 AUST R 296338 · Pfizer Australia Pty Ltd

In supply · Australia

Norimin

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$10.56DPMQ A$25.37details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Estradiol

◷ Expected back

No estimate

No estimate provided

Active ingredient (INN)	Ethinylestradiol
Brand names	Norimin
ATC level 5	G03CA01
ATC level 4	G03CA
Therapeutic category	Auto-created by Therapeutic Goods Administration — Medicine Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Pfizer Australia Pty Ltd, Lupin Australia Pty Limited, SANDOZ LIMITED, CRESCENT PHARMA LIMITED +3 more
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$10.56

AEMP

Dispensed (DPMQ)

A$25.37

incl. fees

Pack

norethisterone 500 microgram + ethinylestradiol 35 microgram tablet [21] (&) inert substance tablet [7], 4 x 28

Source: PBSEffective July 2026 · AUD

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

3 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.

High concentration risk✓ 1 WHO-prequalified

Qinhuangdao Zizhu Pharmaceutical Co LtdBayer AGIndustriale Chimica Srl

Manufacturing countries: China, Germany, Italy · Source: FDA List of Drug Master Files

Verified timeline regulator events

🇨🇦 24 July 2026

medium reported

🇨🇦 13 May 2026

medium reported

🇨🇦 5 May 2026

medium reported

🇨🇦 1 May 2026

medium reported

🇨🇦 15 Apr 2026

medium reported

🇨🇦 10 Apr 2026

medium reported

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders29 registrations · 7 MA holders

Product	Strength	Form	Market	MA holder	Status
LOETTE ethinylestradiol / levonorgestrel tablet blister pack	—	—	🇦🇺 AU	Pfizer Australia Pty Ltd	Active
Amelia-	2 mg	—	🇦🇺 AU	—	Active
Ava-	2 mg	—	🇦🇺 AU	—	Active
Danica-	2 mg	—	🇦🇺 AU	—	Active
Tyra-	2 mg	—	🇦🇺 AU	—	Active
Ethinyloestradiol / Drospirenone	20 microgram	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
NUVARING etonogestrel	11.7 mg	—	🇦🇺 AU	—	Active
ROSIE ethinylestradiol/drospirenone	20 microgram	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
Rosalee	3 mg	—	🇦🇺 AU	Lupin Australia Pty Limited	Active
CYPROTERONE-ETHINYLESTRADIOL-RJIC tablet blister pack	—	—	🇦🇺 AU	—	Active
LEVONORGESTREL/ETHINYLESTRADIOL-RJIC levonorgestrel	150 microgram	—	🇦🇺 AU	—	Active
LEVONORGESTREL/ETHINYLESTRADIOL-DWRN levonorgestrel	100 microgram	—	🇦🇺 AU	—	Active
Leveth	150 microgram	—	🇦🇺 AU	—	Active
Apo-Drospirenone/Ee	3 mg	—	🇦🇺 AU	—	Active
Apotex-Drospirenone/Ee	3 mg	—	🇦🇺 AU	—	Active

+14 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.