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CARNITOR

NDA

LEVOCARNITINE | N018948 | 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

27 trials from ClinicalTrials.gov, 19 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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	—
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
Levocarnitine for Dry Eye in Sjogren's Syndrome NCT03953703	Phase 2	Completed	Vanderbilt University Medical Center	15	2021-11-17 → 2025-09-19
A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients NCT00000912	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	475	— → 2000-05
Carnitine for the Treatment of Atherosclerosis.NCT02117661	Phase 2	Completed	Dr. Amer Johri	177	2015-01 → 2019-05
Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy NCT00227266	Phase 2	Completed	University of Utah	94	2005-09 → 2007-11
Evaluation of Cilostazol in Combination With L-Carnitine NCT00822172	Phase 4	Completed	Colorado Prevention Center	164	2008-09 → 2010-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$64.92

Highest Price

$64.92

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54482-0144-07CARNITOR 330MG TAB	$64.92	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 across 2 drug listings matched to this application (2024)

Carnitor — Levocarnitine (2024)

Total Spending

$226K

Total Claims

981

Beneficiaries

205

Avg Cost/Unit

$1.89

Spending Trend

$389K(2019)→$451K(2020)→$388K(2021)→$544K(2022)→$443K(2023)→$226K(2024)

YoY Change:+28.3%

5yr CAGR:+8.4%

Carnitor — Levocarnitine (With Sugar) (2024)

Total Spending

$46K

Total Claims

113

Beneficiaries

Avg Cost/Unit

$0.35

Spending Trend

$64K(2019)→$68K(2020)→$56K(2021)→$55K(2022)→$56K(2023)→$46K(2024)

YoY Change:+1.5%

5yr CAGR:+4.3%

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

Medicare Part B Spending

CMS physician-administered drug spending for Carnitor (2024)

Total Spending

$3.4M

Total Claims

23,222

Beneficiaries

1,549

ASP Price

$32.18

Spending Trend

$31K(2019)→$4.6M(2020)→$16.2M(2021)→$11.1M(2022)→$5.6M(2023)→$3.4M(2024)

YoY Change:-7.2%

5yr CAGR:+7.5%

HCPCS: J1955 — Injection, levocarnitine, per 1 gm

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

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 -28	View Letter (PDF)
Jun 2, 2015	SUPPL -26	View Letter (PDF)
Apr 9, 2007	SUPPL -24	View Letter (PDF)
Apr 15, 2002	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 330MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 1985

No patent or exclusivity listings for this strength.

#002 — 1GM/10ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Apr 27, 1988