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ACZONE

NDA

DAPSONE | N021794 | ALMIRALL LLC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Lachman Consultant Sevices, Inc.- Citizen Petition FDA-2013-P-0800 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Dapsone Tablets, 50 mg, suitable for submission as an ANDA, with the reference listed drug being Dapsone Tablets USP, 100 mg (ANDA	Other	2013-07-15	WithdrawnUnverified summary	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

60 trials from ClinicalTrials.gov — 1 recruiting, 47 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Randomized Multicenter Study for Isolated Skin Vasculitis NCT02939573	Phase 2	Recruiting	University of Pennsylvania	90	2017-01-01 → 2028-12-31
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria NCT00344006	Phase 3	Completed	GlaxoSmithKline	1,395	2006-06 → 2007-08
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products NCT01313728	Phase 4	Completed	Bausch Health Americas, Inc.	26	2010-12 → 2011-01
Pharmacokinetics and Distribution of Dapsone in Leucocytes After Single-dose and Multiple-dose Administration NCT02493283	Phase 1	Completed	University Medicine Greifswald	23	2011-09 → 2015-03
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites NCT00000826	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	48	— → 1999-05
A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients NCT00000991	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	600	— → 1994-04
Effect of Weight and/or Obesity on Dapsone Drug Concentrations NCT01165840	Phase 4	Completed	Texas Tech University Health Sciences Center	37	2010-07 → 2012-05
A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS NCT00002283	N/A	Completed	Jacobus Pharmaceutical	—	—
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi NCT00164710	Phase 4	Completed	Centers for Disease Control and Prevention	365	2005-04 → 2005-09
A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris NCT01974141	Phase 3	Completed	Almirall, S.A.	2,102	2013-11 → 2014-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1.29

Highest Price

$313.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60758-0670-60DAPSONE 5% GEL,TOP	$45.30	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
60758-0670-60DAPSONE 5% GEL,TOP	$232.16	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
60758-0670-90DAPSONE 5% GEL,TOP	$1.29	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
60758-0670-90DAPSONE 5% GEL,TOP	$313.57	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Aczone (2024)

Total Spending

$78K

Total Claims

Beneficiaries

Avg Cost/Unit

$12.79

Spending Trend

$137K(2020)→$200K(2021)→$155K(2022)→$89K(2023)→$78K(2024)

YoY Change:+0.5%

5yr CAGR:+3.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs3 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPADAPSONE

DMF 150652000

ATUL LTDDAPSONE USP

DMF 177812004

NOVITIUM PHARMA LLCDAPSONE USP

DMF 276782013

SAI LIFE SCIENCES LTDDAPSONE USP

DMF 277012013

TARO PHARMACEUTICAL INDUSTRIES LTDDAPSONE USP

DMF 299992016

DIPHARMA FRANCIS SRLDAPSONE

DMF 315212017

MACLEODS PHARMACEUTICALS LTDDAPSONE

DMF 332282019

EXTROVIS AGDAPSONE

DMF 336302019

MACLEODS PHARMACEUTICALS LTDDAPSONE USP

DMF 352442021

COHANCE LIFESCIENCES LTDDAPSONE USP

DMF 353422020

MEDILUX LABORATORIES PVT LTDDAPSONE USP

DMF 383782023

CHONGQING HUAPONT PHARMACEUTICAL CO LTDDAPSONE

DMF 384832023

JACOBUS PHARMACEUTICAL COInactiveDAPSONE (FINAL DOSAGE FORMS)

DMF 74131988

REGIS TECHNOLOGIES INCInactiveDAPSONE, USP

DMF 250892011

MEDILUX LABORATORIES PVT LTDInactiveDAPSONE USP

DMF 357862022

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 21, 2018	SUPPL -16	View Letter (PDF)
Jul 13, 2015	SUPPL -13	View Letter (PDF)
Mar 18, 2008	SUPPL -5	View Letter (PDF)
Jul 15, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 7, 2005

No patent or exclusivity listings for this strength.