Viewing data from:

XELPROS

NDA

LATANOPROST | N206185 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

9539262

Oct. 15, 2028

9629852

Sep. 12, 2029

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 Xelpros (2023)

Total Spending

$4K

Total Claims

Beneficiaries

Avg Cost/Unit

$18.21

Spending Trend

$2K(2019)→$4K(2020)→$9K(2021)→$8K(2022)→$4K(2023)

YoY Change:+33.6%

5yr CAGR:+0.3%

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

4 letters from Drugs@FDA

Date	Submission	Document
Oct 10, 2024	SUPPL -19	View Letter (PDF)
Oct 10, 2024	SUPPL -19	View Letter (PDF)
Dec 23, 2020	SUPPL -9	View Letter (PDF)
Sep 14, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005%

RLD

2 patents0 exclusivities▴

EMULSION;OPHTHALMIC | Approved: Sep 12, 2018

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9539262	Oct 15, 2028	—	—	—		—
9629852	Sep 12, 2029	—	—	Yes	—	—