Drug facts

Molecule

Levocarnitine (Carnitor)

Generics already compete: 8 makers on the market. 11 A-rated products from 8 makers substitute at the counter.

Carnitor was first approved by the FDA on 12/27/1985 under NDA 018948; the application holder is Leadiant Biosciences Inc.

The latest NADAC for LEVOCARNITINE 1 G/10 ML SOLN is $0.14 per mL (as of 10/28/2026).

Holder Leadiant Biosciences IncApplication NDA 018948Approved 12/27/1985

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 Carnitor patent listed in the Orange Book
Orange Book

02Competition

Generics
8 generic makers
Orange Book
First generic approved
03/29/2001
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 Levocarnitine profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.14 per mLLEVOCARNITINE 1 G/10 ML SOLN, as of 10/28/2026
CMS NADAC
Latest recall
04/16/2026Class III, Levocarnitine, American Regent, Inc.
FDA enforcement

04Product

Application holder
Leadiant Biosciences Inc
Orange Book
Application
NDA 018948
Orange Book
First approved
12/27/1985
Orange Book
Dosage forms
injectable; solution; tablet
Routes
injection, 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.