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ARESTIN

NDA

MINOCYCLINE HYDROCHLORIDE | N050781 | ORAPHARMA 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

188 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 126 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Regeneration of Immature Teeth. Case Series NCT03507556	N/A	Active	Jordan University of Science and Technology	40	2010-06-28 → 2030-12-01
Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery NCT01422148	Phase 2	Not Yet Recruiting	Baystate Medical Center	60	2025-07 → 2028-01-24
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response NCT03414502	Phase 3	Recruiting	University of Nebraska	400	2007-12-10 → 2029-03
Minocycline as Adjunctive Treatment for Treatment Resistant Depression NCT03947827	Phase 3	Completed	Centre for Addiction and Mental Health	76	2020-02-01 → 2025-01-07
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis NCT00529555	Phase 3	Completed	Sunstar Americas	602	2006-01 → 2008-12
Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord Injury NCT00559494	Phase 1/2	Completed	University of Calgary	52	2004-06 → 2010-08
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections NCT01049438	N/A	Completed	Natividad Medical Center	31	2006-08 → 2009-09
Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial NCT02263872	Phase 4	Completed	Pakistan Institute of Living and Learning	41	2014-10 → 2016-08
National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Neuroprotection Trial NCT00063193	Phase 2	Completed	University of Rochester	195	2003-05 → 2005-07
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.NCT04104685	Phase 2	Completed	Vyne Therapeutics Inc.	446	2019-09-18 → 2020-03-03

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

VA Federal Supply Schedule

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

Lowest Price

$41.35

Highest Price

$220.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
65976-0100-01ARESTIN 1MG CARTRIDGE	$99.64	FSS	Bausch Health US, LLC	04/30/2026
65976-0100-01ARESTIN 1MG CARTRIDGE	$41.35	Big4	Bausch Health US, LLC	04/30/2026
65976-0100-24ARESTIN 1MG CARTRIDGE	$220.75	FSS	Bausch Health US, LLC	04/30/2026
65976-0100-24ARESTIN 1MG CARTRIDGE	$220.75	Big4	Bausch Health US, LLC	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Arestin (2024)

Total Spending

$5.1M

Total Claims

1,166

Beneficiaries

1,027

Avg Cost/Unit

$102.76

Spending Trend

$7.5M(2019)→$4.9M(2020)→$5.5M(2021)→$5.5M(2022)→$5.8M(2023)→$5.1M(2024)

YoY Change:-3.6%

5yr CAGR:-0.7%

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

API Supply Chain9 active DMFs7 inactive

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

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

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 28, 2024	SUPPL -25	View Letter (PDF)
May 10, 2017	SUPPL -20	View Letter (PDF)
Jul 31, 2012	SUPPL -19	View Letter (PDF)
Feb 20, 2008	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE

RLD

0 patents0 exclusivities▴

POWDER, EXTENDED RELEASE;DENTAL | Approved: Feb 16, 2001

No patent or exclusivity listings for this strength.