Viewing data from:

IHEEZO

NDA

CHLOROPROCAINE HYDROCHLORIDE | N216227 | HARROW EYE LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

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Today

10792271

Sep. 15, 2038

11969403

May. 14, 2039

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 B Spending

CMS physician-administered drug spending for Iheezo (2023)

Total Spending

$7.8M

Total Claims

13,754

Beneficiaries

8,498

ASP Price

—

HCPCS: J2403 — Chloroprocaine hcl ophthalmic, 3% gel, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SACHLOROPROCAINE HYDROCHLORIDE

DMF 80021989

EDMOND PHARMA SRLCHLOROPROCAINE HYDROCHLORIDE

DMF 356982021

SHANGHAI WONDER PHARMACEUTICAL CO LTDCHLOROPROCAINE HYDROCHLORIDE

DMF 392682023

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveCHLOROPROCAINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 231472009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 8, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3%

RLD

2 patents0 exclusivities▴

GEL;OPHTHALMIC | Approved: Sep 27, 2022

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10792271	Sep 15, 2038	—	—	Yes		—
11969403	May 14, 2039	—	—	Yes	—	—