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FLAREX

NDA

FLUOROMETHOLONE ACETATE | N019079 | 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 Flarex (2023)

Total Spending

$4.0M

Total Claims

27,689

Beneficiaries

15,372

Avg Cost/Unit

$26.50

Spending Trend

$761K(2019)→$1.2M(2020)→$2.2M(2021)→$3.6M(2022)→$4.0M(2023)

YoY Change:+1.7%

5yr CAGR:+10.0%

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Feb 11, 1986

No patent or exclusivity listings for this strength.