Viewing data from:

MAXITROL

NDA

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | N050023 | 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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy NCT02344732	N/A	Completed	Universiti Sains Malaysia	32	2013-10 → 2014-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.63

per ml

Lowest NADAC/Unit

$1.63

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69918051505NEOMYC-POLYM-DEXAMETH EYE DROP	$1.63	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$67.63

Highest Price

$67.63

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0100-05MAXITROL 0.1% SUSP,OPH	$67.63	FSS	Harrow Eye, LLC	03/14/2029

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

Medicare Part D Spending

CMS annual spending data for Maxitrol (2024)

Total Spending

$24K

Total Claims

143

Beneficiaries

129

Avg Cost/Unit

$43.17

Spending Trend

$34K(2019)→$40K(2020)→$17K(2021)→$20K(2022)→$20K(2023)→$24K(2024)

YoY Change:-2.3%

5yr CAGR:-5.2%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 17, 2021	SUPPL -37	View Letter (PDF)
Dec 20, 2017	SUPPL -36	View Letter (PDF)
Apr 14, 2017	SUPPL -32	View Letter (PDF)
Apr 28, 2008	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

RLDAT

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.