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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Arestin (2023)

Total Spending

$5.8M

Total Claims

1,283

Beneficiaries

1,157

Avg Cost/Unit

$106.64

Spending Trend

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

YoY Change:+0.8%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2023). 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.