Viewing data from:

IYUZEH

NDA

LATANOPROST | N216472 | THEA PHARMA INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

Today

8637054

Jul. 8, 2031

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

161 trials from ClinicalTrials.gov, 129 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health NCT00892762	Phase 3	Completed	Alcon Research	434	2009-06 → 2011-05
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure NCT02057575	Phase 2	Completed	Aerie Pharmaceuticals	298	2014-01 → 2014-06
A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase III Study to Evaluate the Efficacy and Safety of TJO-002 in POAG or Ocular Hypertension Patients NCT03419975	Phase 3	Completed	Taejoon Pharmaceutical Co., Ltd.	146	2016-04-26 → 2018-06-01
A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)NCT00051155	Phase 3	Completed	Alcon Research	—	2001-01 → 2004-07
Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops NCT00402493	N/A	Completed	Philadelphia Eye Associates	51	2006-12 → 2008-03
Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy NCT01263444	Phase 4	Completed	Alcon Research	47	2011-03 → 2013-04
A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular Hypertension NCT01379144	Phase 2	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	282	2003-01 → 2003-04
POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma NCT02466399	Phase 2	Completed	Peregrine Ophthalmic	80	2015-07 → 2016-04
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects NCT00735449	Phase 4	Completed	Allergan	204	2008-07 → 2009-12
Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health NCT00761319	Phase 3	Completed	Alcon Research	705	2008-10 → 2009-09

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

$10.12

per ea

Lowest NADAC/Unit

$10.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82584000330IYUZEH 0.005% EYE DROP	$10.12	EA	Brand	—	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

$227.46

Highest Price

$227.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82584-0003-30IYUZEH 0.005% SOLN,OPH	$227.46	FSS	Thea Pharma, Inc.	01/31/2028

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

Medicare Part D Spending

CMS annual spending data for Iyuzeh (2024)

Total Spending

$6.7M

Total Claims

15,866

Beneficiaries

5,390

Avg Cost/Unit

$9.63

Spending Trend

$252K(2023)→$6.7M(2024)

YoY Change:-6.2%

5yr CAGR:-6.2%

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

API Supply Chain17 active DMFs5 inactive

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

CAYMAN CHEMICAL CO INCLATANOPROST DRUG SUBSTANCE

DMF 174452004

CHIROGATE INTERNATIONAL INCLATANOPROST

DMF 183432005

FINETECH PHARMACEUTICAL LTDLATANOPROST DRUG SUBSTANCE

DMF 195352006

YS LIFE SCIENCE CO LTDLATANOPROST

DMF 210442007

EVERLIGHT CHEMICAL INDUSTRIAL CORPLATANOPROST

DMF 215042008

TAPI NL BVLATANOPROST

DMF 221982008

C-SQUARED PHARMA LTDLATANOPROST USP

DMF 235392010

FDC LTDLATANOPROST USP

DMF 238132010

INDUSTRIALE CHIMICA SRLLATANOPROST

DMF 259312012

CAYMAN PHARMA SROLATANOPROST

DMF 260812012

DELTA BIOTECH SALATANOPROST

DMF 261812012

EUROAPI HUNGARY LTDLATANOPROST

DMF 267282012

MSN LABORATORIES PRIVATE LTDLATANOPROST USP [ROUTE CODE- "LO"]

DMF 273072013

KYOWA PHARMA CHEMICAL CO LTDLATANOPROST

DMF 329892018

GENTEC SALATANOPROST

DMF 343692020

NEWCHEM SPALATANOPROST

DMF 395502024

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDLATANOPROST

DMF 418662025

RESOLUTION CHEMICALS LTDInactiveLATANOPROST

DMF 154622001

SAI LIFE SCIENCES LTDInactiveLATANOPROST, NON-STERILE BULK DRUG SUBSTANCE

DMF 209252007

MYLAN LABORATORIES LTDInactiveLATANOPROST

DMF 242082010

PATHEON API MANUFACTURING INCInactiveLATANOPROST

DMF 259242012

LUPIN LTDInactiveLATANOPROST USP

DMF 276452013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 17, 2024	SUPPL -2	View Letter (PDF)
Dec 15, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005%

RLD

1 patent0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 13, 2022

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8637054	Jul 8, 2031	—	—	Yes		—