Clonazepam shortage — US supply status & alternatives

Clonazepam

ATC N03AE01

In supply · Australia

In supply · 🇦🇺 Australia · short in🇺🇸 US🇨🇦 CA🇪🇸 ES🇮🇹 IT🇧🇪 BE

In supply in Australia

Reading today’s signals…

🇦🇺 AUAEMPA$3.15DPMQ A$21.14details →

✓ Can I substitute?

Per normal rules

Confirm with prescriber

⇄ Best alternative

Levetiracetam

◷ Expected back

No estimate

No estimate provided

Product attributes reference data we hold

Active ingredient (INN)	Clonazepam

ATC level 5	N03AE01

ATC level 4	N03AE

Therapeutic category	Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper

Controlled substance	No

Marketing-authorisation holders	TEVA UK LIMITED, ROSEMONT PHARMACEUTICALS LIMITED, TILLOMED LABORATORIES LIMITED, CRESCENT PHARMA LIMITED +9 more

Registrations on file	28

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$3.15

AEMP

Dispensed (DPMQ)

A$21.14

incl. fees

Pack

clonazepam 500 microgram tablet, 50

Source: PBSEffective July 2026 · AUD

Other markets

🇬🇧 GB

£2.08

Drug Tariff

🇺🇸 US

US$0.02

Acquisition

🇪🇸 ES

€2.08

Retail price

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

Centaur Pharmaceuticals PVT LTDFis Fabbrica Italiana Sintetici SPACambrex Profarmaco Milano SrlPh Health LTDSun Pharmaceutical Industries LTDApotex Pharmachem India PVT LTD+1 more

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

Recalls official enforcement reports

🇺🇸

CLONAZEPAM

Endo USA, Inc. · Nov 2024

Class Idetails ↗

🇺🇸

CLONAZEPAM

Endo USA, Inc. · Nov 2024

Class Idetails ↗

🇺🇸

CLONAZEPAM

Endo USA, Inc. · Nov 2024

Class Idetails ↗

🇺🇸

CLONAZEPAM

Endo USA, Inc. · Nov 2024

Class Idetails ↗

🇺🇸

CLONAZEPAM

Endo Pharmaceuticals, Inc. · July 2024

Class Idetails ↗

🇺🇸

Clonazepam Tablets

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Sept 2016

Class IIIdetails ↗

Sources official regulators

🇨🇦

verified just now

verify ↗

🇺🇸

FDA

verified just now

verify ↗

🇧🇪

FAMHP

verified 6h ago

verify ↗

🇮🇹

AIFA

verified 11h ago

verify ↗

🇺🇸

FDA MedWatch

verified 1mo ago

verify ↗

🇪🇸

AEMPS

verified 1mo ago

verify ↗

Registration recordmarketing-authorisation holders

Registrations & marketing-authorisation holders28 registrations · 13 MA holders

Product	Strength	Form	Market	MA holder	Status
CLONAZEPAM 500 MICROGRAM TABLETS	500 MICROGRAM	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
CLONAZEPAM 2 MG TABLETS	2 MG	tablet	🇬🇧 GB	TEVA UK LIMITED	Active
Clonazepam Rosemont	0.5MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Clonazepam Rosemont	2MG	solution	🇬🇧 GB	ROSEMONT PHARMACEUTICALS LIMITED	Active
Clonazepam Tillomed	0.5MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Clonazepam Tillomed	2MG	tablet	🇬🇧 GB	TILLOMED LABORATORIES LIMITED	Active
Clonazepam Crescent	0.5MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Clonazepam Crescent	2MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Clonazepam Crescent	0.5 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Clonazepam Crescent	2 MG	tablet	🇬🇧 GB	CRESCENT PHARMA LIMITED	Active
Clonazepam Alissa	0.5 MG	tablet	🇬🇧 GB	ALISSA HEALTHCARE RESEARCH LIMITED	Active
Clonazepam Alissa	2 MG	tablet	🇬🇧 GB	ALISSA HEALTHCARE RESEARCH LIMITED	Active
Clonazepam Dawa	0.5 MG	tablet	🇬🇧 GB	DAWA LIMITED	Active
Clonazepam Dawa	2 MG	tablet	🇬🇧 GB	DAWA LIMITED	Active
Clonazepam Rivopharm	0.5MG	tablet	🇬🇧 GB	RIVOPHARM (UK) LIMITED	Active

+13 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.