Viewing data from:

LUCEMYRA

NDA

LOFEXIDINE HYDROCHLORIDE | N209229 | BIOCORRX PHARMACEUTICALS INC

1 strength0 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 Lucemyra (2023)

Total Spending

$3.1M

Total Claims

979

Beneficiaries

781

Avg Cost/Unit

$24.55

Spending Trend

$1.2M(2021)→$2.5M(2022)→$3.1M(2023)

YoY Change:+9.5%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

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

MSN LABORATORIES PRIVATE LTDLOFEXIDINE HYDROCHLORIDE

DMF 346362020

PROCOS SPALOFEXIDINE HYDROCHLORIDE

DMF 375432022

MEDICHEM MANUFACTURING (MALTA) LTDLOFEXIDINE HYDROCHLORIDE

DMF 379782023

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 6, 2024	SUPPL -7	View Letter (PDF)
May 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.18MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 16, 2018

No patent or exclusivity listings for this strength.