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IOPIDINE

NDA

APRACLONIDINE HYDROCHLORIDE | N020258 | 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

3 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults NCT07531043	Phase 3	Not Yet Recruiting	Alcon Research	230	2026-10 → 2027-02
An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults NCT07578363	Phase 3	Not Yet Recruiting	Alcon Research	178	2026-09 → 2027-03
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty NCT00567411	N/A	UNKNOWN	Walter Reed Army Medical Center	43	2006-08 → 2009-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$9.51

per ml

Lowest NADAC/Unit

$9.45

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314066510APRACLONIDINE HCL 0.5% DROPS	$9.51	ML	Generic	—	2026-08-19
61314066505APRACLONIDINE HCL 0.5% DROPS	$9.45	ML	Generic	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$21.34

Highest Price

$22.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61314-0665-05APRACLONIDINE HCL 0.5%SOLN,OPH	$21.34	FSS	Sandoz, Inc.	08/14/2028
61314-0665-10APRACLONIDINE HCL 0.5%SOLN,OPH	$22.58	FSS	Sandoz, Inc.	08/14/2028

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

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

4 letters from Drugs@FDA

Date	Submission	Document
Mar 20, 2026	SUPPL -34	View Letter (PDF)
Mar 5, 2018	SUPPL -30	View Letter (PDF)
Apr 12, 2017	SUPPL -26	View Letter (PDF)
Jun 8, 2004	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jul 30, 1993

No patent or exclusivity listings for this strength.