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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Newcastle Bioscience, LLC FDA-2023-P-4281 Newcastle Bioscience, LLC filed a suitability petition requesting FDA review and approval of a proposed manufacturing process or formulation. The petition seeks the agency's determination regarding the suitability of the applicant's approach for compliance with regulatory requirements, though the sp	Suitability	2023-10-02	Open	Newcastle Bioscience

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy (PBK)NCT06960629	Phase 2/3	Completed	University Hospital Dubrava	50	2025-01-01 → 2026-05-01

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

Medicare Part D Spending

CMS annual spending data for Xalatan (2023)

Total Spending

$5.4M

Total Claims

11,520

Beneficiaries

2,542

Avg Cost/Unit

$98.62

Spending Trend

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

YoY Change:+8.4%

5yr CAGR:+6.0%

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

API Supply Chain17 active DMFs4 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

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.