LEVOCARNITINE | N018948 | LEADIANT BIOSCIENCES INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Children's Oncology Group | 440 | 2023-08-24 → 2028-12-30 | |
| Phase 2 | Active | Ain Shams University | 76 | 2025-06-01 → 2026-12 | |
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 PatientNCT00002184 | Phase 2 | Completed | Gilead Sciences | 120 | — |
| Phase 4 | Completed | Colorado Prevention Center | 164 | 2008-09 → 2010-12 | |
| N/A | Completed | Gilead Sciences | — | — | |
| Phase 3 | Completed | ECOG-ACRIN Cancer Research Group | 376 | 2005-12-16 → 2011-05 | |
| Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 300 | — → 2000-07 | |
| Phase 2/3 | Completed | Lee's Pharmaceutical Limited | 268 | 2011-01 → 2012-03 | |
| Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 505 | 1996-12 → 1999-08 | |
| Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 440 | — → 2003-06 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$64.92
Highest Price
$64.92
FSS NDCs
1
Big4 NDCs
0
| 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.
Total Spending
$226K
Total Claims
981
Beneficiaries
205
Avg Cost/Unit
$1.89
Spending Trend
Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.
Total Spending
$3.4M
Total Claims
23,222
Beneficiaries
1,549
ASP Price
$32.18
Spending Trend
HCPCS: J1955 — Injection, levocarnitine, per 1 gm
Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.
9 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| 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.
No patent or exclusivity listings for this strength.