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IOPIDINE

NDA

APRACLONIDINE HYDROCHLORIDE | N019779 | HARROW EYE 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

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 Iopidine (2023)

Total Spending

$105K

Total Claims

Beneficiaries

Avg Cost/Unit

$28.59

Spending Trend

$85K(2019)→$89K(2020)→$78K(2021)→$83K(2022)→$105K(2023)

YoY Change:+1.7%

5yr CAGR:-0.9%

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PCASAPRACLONIDINE HYDROCHLORIDE

DMF 166012003

FORMOSA LABORATORIES INCAPRACLONIDINE HYDROCHLORIDE

DMF 167682003

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1% BASE

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 31, 1987

No patent or exclusivity listings for this strength.