Drug facts

Molecule

Clonazepam (Klonopin)

Generics already compete: 11 makers on the market. 44 A-rated products from 11 makers substitute at the counter.

Klonopin was first approved by the FDA before 1982 under NDA 017533; the application holder is Cheplapharm Arzneimittel GMBH.

Clonazepam Tablet is on the current FDA drug shortage list, first posted 03/10/2023.

Holder Cheplapharm Arzneimittel GMBHApplication NDA 017533Approved before 1982

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent
No Klonopin patent listed in the Orange Book
Orange Book

02Competition

Generics
11 generic makers
Orange Book
First generic approved
09/10/1996
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Clonazepam profile.See what is included

03Supply and price

FDA drug shortage
ActiveClonazepam Tablet is on the current shortage listsince 03/10/2023, available
FDA shortages
NADAC
$0.04 per unitCLONAZEPAM 2 MG TABLET, mid-priced of 6 strengths, as of 10/28/2026
CMS NADAC
Latest recall
11/18/2024Class I, Clonazepam, Endo USA, Inc.
FDA enforcement

04Product

Application holder
Cheplapharm Arzneimittel GMBH
Orange Book
Application
NDA 017533
Orange Book
First approved
before 1982
Orange Book
Dosage forms
tablet; tablet, orally disintegrating
Routes
oral

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.