Pralatrexate — supply status, manufacturers & alternatives

Pralatrexate

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🇦🇺 AUST R 192493 · Mundipharma Pty Ltd

Anticipated · Australia

Folotyn

Anticipated · 🇦🇺 Australia

Anticipated shortage

Reading today’s signals…

🇦🇺 AUAEMPA$1035.50DPMQ A$4381.67details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

None listed

refer to prescriber

◷ Expected back

Aug 2026

Sponsor est. via TGA

Product attributes reference data we hold

Active ingredient (INN)	Pralatrexate

Therapeutic category	Auto-created by EMA — Withdrawn / Refused / Revoked Medicines scraper

Controlled substance	No

Marketing-authorisation holders	Mundipharma Pty Ltd, Dr.Reddy's Laboratories Inc.,

Registrations on file	4

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$1035.50

AEMP

Dispensed (DPMQ)

A$4381.67

incl. fees

Pack

pralatrexate 20 mg/mL injection, 1 mL vial

Source: PBSEffective July 2026 · AUD

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

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

Hetero Labs LTDTapi Nl BVGland Pharma LTD

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

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders4 registrations · 2 MA holders

Product	Strength	Form	Market	MA holder	Status
FOLOTYN pralatrexate	20 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
FOLOTYN pralatrexate	40 mg	—	🇦🇺 AU	Mundipharma Pty Ltd	Active
Pralatrexate	20mg/mL	injection	🇺🇸 US	Dr.Reddy's Laboratories Inc.,	Active
Pralatrexate	40mg/2mL	injection	🇺🇸 US	Dr.Reddy's Laboratories Inc.,	Active

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.