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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

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis NCT07660081	N/A	Active	Khyber Medical University Peshawar	100	2025-11-01 → 2026-08-30
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)NCT02016430	N/A	Recruiting	The Cleveland Clinic	170	2014-04-04 → 2026-12
A Study to Improve Skeletal Muscle in Veterans With HIV NCT06845046	N/A	Recruiting	VA Office of Research and Development	70	2025-07-15 → 2029-03-30
Comparative Evaluation of the Efficacy of Letrozole, L-Carnitine, and Their Combination on Sperm Quality, Oxidative Stress, and ART Outcomes in Men With Idiopathic Oligoasthenoteratozoospermia.NCT07669402	Phase 2/3	Completed	Tehran University of Medical Sciences	90	2023-12-01 → 2026-03-31

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

Medicare Part D Spending

CMS annual spending data for Carnitor (2023)

Total Spending

$56K

Total Claims

131

Beneficiaries

Avg Cost/Unit

$0.35

Spending Trend

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

YoY Change:+8.2%

5yr CAGR:+4.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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 -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