Phenytoin shortage — CA supply status & alternatives

Phenytoin

—

🇦🇺 AUST R 297268 · Mylan Health Pty Ltd

In supply · Australia

Epanutin_inj.Sol_50mg/Ml_bt

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

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$12.20DPMQ A$39.80details →

✓ 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

Brand names	Epanutin_inj.Sol_50mg/Ml_bt

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

Controlled substance	No

Marketing-authorisation holders	Hospira UK Limited, Generics (UK) Limited, FLYNN PHARMA LIMITED, MERCURY PHARMACEUTICALS LIMITED +10 more

Registrations on file	27

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$12.20

AEMP

Dispensed (DPMQ)

A$39.80

incl. fees

Pack

phenytoin 30 mg/5 mL oral liquid, 500 mL

Source: PBSEffective July 2026 · AUD

Other markets

🇺🇸 US

US$2.10

Acquisition

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 1 resolved event

◷

~0 month

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

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

2 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

Recordati Industria Chimica E Farmaceutica SPAKunshan Oriental Pharmaceutical CO LTD

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Jan 2017

Latest approval

Shortage status by regulator official notices

🇨🇦

Canada

HC · 10h ago

Critical

🇺🇸

United States

ANSM Ruptures · 1mo ago

High

🇬🇷

EOF · 1mo ago

Resolved

Recalls official enforcement reports

🇺🇸

PHENYTOIN

Taro Pharmaceuticals U.S.A., Inc. · Feb 2020

Class Idetails ↗

Verified timeline regulator events

🇬🇷 4 May 2026

Shortage resolved

🇨🇦 6 Mar 2026

critical reported

🇺🇸 7 Feb 2020

high reported

Sources official regulators

🇨🇦

verified 10h ago

verify ↗

🇺🇸

ANSM Ruptures

verified 1mo ago

verify ↗

🇬🇷

EOF

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders27 registrations · 14 MA holders

Product	Strength	Form	Market	MA holder	Status
Phenytoin Hospira Injection Bp	—	injection	🇬🇧 GB	Hospira UK Limited	Active
Phenytoin Sodium Mylan	25 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	50 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	100 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Mylan	300 MG	capsule	🇬🇧 GB	Generics (UK) Limited	Active
Phenytoin Sodium Flynn	25 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	50 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	100 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium Flynn	300 MG	capsule	🇬🇧 GB	FLYNN PHARMA LIMITED	Active
Phenytoin Sodium	50MG	injection	🇬🇧 GB	MERCURY PHARMACEUTICALS LIMITED	Active
Phenytoin Hikma	50 MG	injection	🇬🇧 GB	HIKMA FARMACEUTICA (PORTUGAL) SA	Active
Phenytoin Sodium Milpharm	100MG	tablet	🇬🇧 GB	MILPHARM LIMITED	Active
DILANTIN INFATABS phenytoin	50 mg	—	🇦🇺 AU	Mylan Health Pty Ltd	Active
PHENYTOIN 100MG COATED TABLETS	100MG	tablet	🇬🇧 GB	AUSTIN MCNEIL LTD	Active
Phenytoin	125mg/5mL	suspension	🇺🇸 US	PAI Holdings, LLC dba PAI Pharma	Active

+12 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.