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CARNITOR

NDA

LEVOCARNITINE | N019257 | LEADIANT BIOSCIENCES INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

29 trials from ClinicalTrials.gov, 2 active, 19 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma NCT05602194	Phase 3	Active	Children's Oncology Group	440	2023-08-24 → 2028-12-30
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI NCT06564909	Phase 2	Active	Ain Shams University	76	2025-06-01 → 2026-12
Evaluation of Cilostazol in Combination With L-Carnitine NCT00822172	Phase 4	Completed	Colorado Prevention Center	164	2008-09 → 2010-12
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient NCT00002184	Phase 2	Completed	Gilead Sciences	120	—
Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy NCT00227266	Phase 2	Completed	University of Utah	94	2005-09 → 2007-11
The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs NCT00001087	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	300	— → 2000-07
The Clinical Study of the Efficacy and Safety of L-Carnitine Injection in Treatment of Heart Failure NCT01580553	Phase 2/3	Completed	Lee's Pharmaceutical Limited	268	2011-01 → 2012-03
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants NCT01783041	Phase 2/3	Completed	Montefiore Medical Center	144	2013-01 → 2021-12-28
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients NCT00001082	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	505	1996-12 → 1999-08
Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 NCT00000885	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	440	— → 2003-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$0.5426

per ml

Lowest NADAC/Unit

$0.5426

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
54482014801CARNITOR SF 1 GM/10 ML SOLN	$0.5426	ML	Brand	$0.2537	2026-10-21
54482014802CARNITOR SF 1 GM/10 ML SOLN	$0.5426	ML	Brand	$0.2537	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$24.15

Highest Price

$32.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54482-0145-09CARNITOR 1GM/10ML ORAL SOLUTION	$24.15	FSS	Leadiant Biosciences, Inc.	08/31/2026
54482-0148-01CARNITOR SUGAR FREE ORAL SOLUTION 4OZ	$32.46	FSS	Leadiant Biosciences, Inc.	08/31/2026
54482-0148-02CARNITOR SUGAR FREE ORAL SOLUTION 4OZ	$32.46	FSS	Leadiant Biosciences, Inc.	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Carnitor SF (2024)

Total Spending

$8K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$0.45

Spending Trend

$18K(2019)→$13K(2020)→$8K(2021)→$7K(2022)→$7K(2023)→$8K(2024)

YoY Change:+3.7%

5yr CAGR:+6.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs2 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

ACETO CORPLEVOCARNITINE USP

DMF 161502002

CHENGDA PHARMACEUTICALS CO LTDLEVOCARNITINE USP

DMF 191422006

PHARMARESOURCES (KAIYUAN) CO LTDLEVOCARNITINE

DMF 367462022

SS PHARMA LLCLEVOCARNITINE USP

DMF 370332022

API PHARMA TECH LLCLEVOCARNITINE USP

DMF 371662022

METROCHEM API PRIVATE LTDLEVOCARNITINE USP

DMF 389932023

GLAND PHARMA LTDLEVOCARNITINE

DMF 391682023

ZHEJIANG BAMBOO PHARMACEUTICALS CO LTDLEVOCARNITINE

DMF 393752024

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDLEVOCARNITINE

DMF 408032024

LONZA BIOTEC SROInactiveLEVOCARNITINE TARTATE

DMF 140891999

NORTHEAST GENERAL PHARMACEUTICAL FACTORYInactiveLEVOCARNITINE

DMF 201022006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2018	SUPPL -14	View Letter (PDF)
Jun 2, 2015	SUPPL -12	View Letter (PDF)
Apr 9, 2007	SUPPL -11	View Letter (PDF)
Apr 15, 2002	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM/10ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Apr 10, 1986

No patent or exclusivity listings for this strength.

#002 — 1GM/10ML

RLDAA

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Mar 28, 2007