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XALATAN

NDA

LATANOPROST | N020597 | UPJOHN US 2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

167 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 132 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension NCT06964191	Phase 2	Active	PolyActiva Pty Ltd	75	2025-05-31 → 2026-11-15
Optic Nerve Head Strain in Non-glaucoma Subjects NCT07425535	Early Phase 1	Recruiting	Johns Hopkins University	30	2026-06-24 → 2028-03-31
Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects NCT04401982	Phase 4	Recruiting	University of Maryland, Baltimore	50	2026-07-02 → 2027-03-17
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension NCT00690794	Phase 3	Completed	Alcon Research	726	2008-07 → 2009-05
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®NCT00799682	Phase 4	Completed	Ophthalmic Consultants of Long Island	56	2008-10 → 2011-02
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
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma NCT04060758	Phase 1	Completed	PolyActiva Pty Ltd	37	2020-03-11 → 2025-05-13

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 (1 brand, 1 generic)

Highest NADAC/Unit

$108.35

per ml

Lowest NADAC/Unit

$1.57

per ml

Brand NDCs

Generic NDCs

Avg Brand: $108.35

Avg Generic: $1.57

99% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
58151041935XALATAN 0.005% EYE DROPS	$108.35	ML	Brand	$1.57	2026-08-19
59762033302LATANOPROST 0.005% EYE DROPS	$1.57	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$0.96

Highest Price

$164.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58151-0419-35XALATAN 0.005% STERILE SOLN	$164.02	Big4	Mylan Specialty L.P.	01/14/2027
58151-0419-35XALATAN 0.005% STERILE SOLN	$164.02	FSS	Mylan Specialty L.P.	01/14/2027
59762-0333-02LATANOPROST 0.005% SOLN,OPH	$0.96	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0333-02LATANOPROST 0.005% SOLN,OPH	$2.08	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

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

Medicare Part D Spending

CMS annual spending data for Xalatan (2024)

Total Spending

$4.9M

Total Claims

10,322

Beneficiaries

2,384

Avg Cost/Unit

$97.68

Spending Trend

$9.0M(2019)→$8.4M(2020)→$6.5M(2021)→$5.7M(2022)→$5.4M(2023)→$4.9M(2024)

YoY Change:-1.0%

5yr CAGR:+5.2%

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

11 letters from Drugs@FDA

Date	Submission	Document
Sep 2, 2020	SUPPL -52	View Letter (PDF)
Apr 14, 2017	SUPPL -51	View Letter (PDF)
Nov 28, 2014	SUPPL -48	View Letter (PDF)
Nov 28, 2014	SUPPL -45	View Letter (PDF)
Mar 15, 2012	SUPPL -44	View Letter (PDF)
Sep 7, 2010	SUPPL -36	View Letter (PDF)
Sep 7, 2010	SUPPL -35	View Letter (PDF)
Jul 28, 2003	SUPPL -28	View Letter (PDF)
Jul 28, 2003	SUPPL -29	View Letter (PDF)
Apr 4, 2003	SUPPL -10	View Letter (PDF)
Aug 26, 2002	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 5, 1996

No patent or exclusivity listings for this strength.