Viewing data from:

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Carnitor SF (2023)

Total Spending

$7K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$0.43

Spending Trend

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

YoY Change:+9.3%

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 -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