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

32 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse NCT00373503	Phase 2	Completed	New York State Psychiatric Institute	8	2005-08 → 2008-09
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal NCT01863186	Phase 3	Completed	USWM, LLC (dba US WorldMeds)	603	2013-06 → 2014-12
Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects NCT02446002	Phase 1	Completed	USWM, LLC (dba US WorldMeds)	25	2015-05 → 2015-06
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment NCT04056182	Phase 2	Completed	New York State Psychiatric Institute	20	2019-09-01 → 2021-01-29
An Innovative Intervention for OUD Treatment NCT04325659	Phase 2/3	Completed	Johns Hopkins University	36	2020-11-15 → 2025-04-20
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3 NCT00000354	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	—	1996-07 → 1997-12
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans NCT04360681	Phase 2	Completed	Pharmacotherapies for Alcohol and Substance Use Disorders Alliance	84	2021-03-09 → 2026-01-29
Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients NCT01820442	Phase 1	Completed	USWM, LLC (dba US WorldMeds)	30	2013-03 → 2013-09
Lofexidine Mass Balance in Volunteers NCT01629446	Phase 1	Completed	USWM, LLC (dba US WorldMeds)	6	2012-05 → 2012-06
Main Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients NCT01650649	Phase 1	Completed	USWM, LLC (dba US WorldMeds)	27	2012-07 → 2012-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$23.22

per ea

Lowest NADAC/Unit

$9.48

per ea

Brand NDCs

Generic NDCs

Avg Brand: $23.22

Avg Generic: $9.48

59% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78670005036LUCEMYRA 0.18 MG TABLET	$23.22	EA	Brand	$9.48	2025-11-19
78670005096LUCEMYRA 0.18 MG TABLET	$23.22	EA	Brand	$9.48	2025-11-19
66993034537LOFEXIDINE 0.18 MG TABLET	$9.48	EA	Generic	—	2026-06-17
66993034576LOFEXIDINE 0.18 MG TABLET	$9.48	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$266.19

Highest Price

$1840.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0345-37LOFEXIDINE 0.18MG TAB	$371.86	FSS	Prasco, LLC	06/30/2026
66993-0345-37LOFEXIDINE 0.18MG TAB	$266.19	Big4	Prasco, LLC	06/30/2026
66993-0345-76LOFEXIDINE 0.18MG TAB	$836.68	FSS	Prasco, LLC	06/30/2026
66993-0345-76LOFEXIDINE 0.18MG TAB	$435.70	Big4	Prasco, LLC	06/30/2026
78670-0050-36LUCEMYRA 0.18MG TAB	$773.29	FSS	USWM, LLC	08/14/2026
78670-0050-36LUCEMYRA 0.18MG TAB	$641.52	Big4	USWM, LLC	08/14/2026
78670-0050-96LUCEMYRA 0.18MG TAB	$1840.44	FSS	USWM, LLC	08/14/2026
78670-0050-96LUCEMYRA 0.18MG TAB	$1662.04	Big4	USWM, LLC	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Lucemyra (2024)

Total Spending

$1.9M

Total Claims

597

Beneficiaries

446

Avg Cost/Unit

$23.96

Spending Trend

$1.2M(2021)→$2.5M(2022)→$3.1M(2023)→$1.9M(2024)

YoY Change:-2.4%

5yr CAGR:+3.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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.