Ibutilide Fumarate shortage — US supply status & alternatives

Ibutilide Fumarate

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In supply · Australia

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

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

Active ingredient (INN)	Ibutilide Fumarate
Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper
Controlled substance	No
Marketing-authorisation holders	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Mylan Institutional LLC

Registrations on file	2

Patient information leaflet (PIL)	Not on file

Summary of product characteristics (SPC)	Not on file

Trade price 🇦🇺 Australia · awaiting price ingest

🇦🇺 AU

Ex-manufacturer

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Dispensed (DPMQ)

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Pack

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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.

Substitution pathways 🇦🇺 Australia · TGA

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No substitution instrument in force

Dispense per normal rules, or refer to the prescriber. No active SSSI/S19A instrument detected for this medicine.

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

Emcure Pharmaceuticals LTDSai Life Sciences LTD

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

Shortage status by regulator official notices

🇺🇸

United States

FDA · just now

Medium

🇮🇹

Italy

AIFA · 11h ago

Resolved

Verified timeline regulator events

🇮🇹 31 Aug 2026

Shortage resolved

🇺🇸 5 Mar 2025

medium reported

🇺🇸 5 Mar 2025

medium reported

Sources official regulators

🇺🇸

FDA

verified just now

verify ↗

🇮🇹

AIFA

verified 11h ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
Ibutilide Fumarate	1mg/10mL	injection	🇺🇸 US	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	Active
Ibutilide Fumarate	.1mg/mL	injection	🇺🇸 US	Mylan Institutional LLC	Discontinued

Mederti Drug Report

Generated 2 July 2026 · Australia market · 2 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.