Bexarotene — supply status, manufacturers & alternatives

Bexarotene

ATC L01XF03

In supply · Australia

Bexarotene CiplaBexaroteno Cipla

In supply · 🇦🇺 Australia

In supply in Australia

No active shortage reported.

Reading today’s signals…

✓ 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

Therapeutic category
Active ingredient (INN)	Bexarotene
Brand names	Bexarotene Cipla, Bexaroteno Cipla
ATC level 5	L01XF03
ATC level 4	L01XF

Controlled substance	No

Marketing-authorisation holders	Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals NY 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

—

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$5.60

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 2 resolved events

◷

2–3 months

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

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

7 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

Apicore Us LLCRefarmed Chemicals LTDHetero Labs LTDMsn Laboratories Private LTDTianjin Weijie Pharmaceutical CO LTDEmcure Pharmaceuticals LTD+1 more

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

FDA-approved products 🇺🇸 Drugs@FDA

Approved applications

Generic (ANDA)

Brand (NDA/BLA)

Mar 2024

Latest approval

Shortage status by regulator official notices

🇮🇹

Italy

AIFA · 1d ago

Resolved

Recalls official enforcement reports

🇺🇸

BEXAROTENE

Upsher Smith Laboratories, Inc. · July 2019

Class IIdetails ↗

Verified timeline regulator events

🇮🇹 29 Apr 2026

Shortage resolved

🇮🇹 9 Oct 2025

Shortage resolved

Sources official regulators

🇮🇹

AIFA

verified 1d ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders2 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
Bexarotene	75mg/1	capsule	🇺🇸 US	Mylan Pharmaceuticals Inc.	Active
Bexarotene	10mg/g	gel	🇺🇸 US	Amneal Pharmaceuticals NY LLC	Active

Mederti Drug Report

Generated 6 July 2026 · Australia market · 1 regulatory source

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.