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ISTALOL

NDA

TIMOLOL MALEATE | N021516 | BAUSCH AND LOMB INC

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

219 trials from ClinicalTrials.gov — 1 recruiting, 180 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn NCT01873131	N/A	Recruiting	Massachusetts General Hospital	126	2011-02 → 2028-12
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma NCT00869141	Phase 4	Completed	University of California, Los Angeles	52	2009-03 → 2013-03
Intraocular Pressure and Ocular Perfusion Pressure of Cosopt in Normal Tension Glaucoma NCT01175902	N/A	Completed	The Catholic University of Korea	44	2011-03 → 2014-10
Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma NCT01471158	Phase 4	Completed	Alcon Research	120	2010-09 → 2011-05
Efficacy and Safety of 0.25% Timolol Gel in Healing Surgical Open Wounds NCT03452072	Phase 2/3	Completed	Brigham and Women's Hospital	87	2018-08-20 → 2021-06-30
Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy NCT01779284	Phase 4	Completed	Aristotle University Of Thessaloniki	42	2012-01 → 2013-01
Topical Timolol Gel for the Treatment of Infantile Hemangiomas NCT02145884	Phase 2	Completed	Rady Children's Hospital, San Diego	26	2014-05 → 2016-11
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension NCT02558374	Phase 3	Completed	Aerie Pharmaceuticals	708	2015-09 → 2016-12
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom NCT00751049	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	294	1992-12 → 1993-12
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide NCT01062971	Phase 2	Completed	Laboratorios Sophia S.A de C.V.	124	2006-02 → 2008-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs (2 brand, 2 generic)

Highest NADAC/Unit

$80.06

per ml

Lowest NADAC/Unit

$11.43

per ml

Brand NDCs

Generic NDCs

Avg Brand: $79.91

Avg Generic: $17.03

79% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208000403ISTALOL 0.5% EYE DROPS	$80.06	ML	Brand	$22.63	2026-06-17
24208000401ISTALOL 0.5% EYE DROPS	$79.76	ML	Brand	$11.43	2026-06-17
82260004505TIMOLOL 0.5% EYE DROP	$22.63	ML	Generic	—	2026-06-17
82260004525TIMOLOL 0.5% EYE DROP	$11.43	ML	Generic	—	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$0.01

Highest Price

$339.60

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68682-0045-25TIMOLOL MALEATE 0.5% SOLN,OPH	$27.37	FSS	Bausch & Lomb Americas Inc.	09/14/2027
68682-0045-25TIMOLOL MALEATE 0.5% SOLN,OPH	$0.01	Big4	Bausch & Lomb Americas Inc.	09/14/2027
68682-0045-50TIMOLOL MALEATE 0.5% SOLN,OPH	$65.01	FSS	Bausch & Lomb Americas Inc.	09/14/2027
68682-0045-50TIMOLOL MALEATE 0.5% SOLN,OPH	$25.31	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0004-01ISTALOL 0.5% OPHTH SOLN	$165.97	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0004-01ISTALOL 0.5% OPHTH SOLN	$150.93	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0004-03ISTALOL 0.5% OPHTH SOLN	$339.60	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0004-03ISTALOL 0.5% OPHTH SOLN	$299.33	Big4	Bausch & Lomb Americas Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Istalol (2024)

Total Spending

$652K

Total Claims

1,279

Beneficiaries

323

Avg Cost/Unit

$78.54

Spending Trend

$4.0M(2019)→$3.7M(2020)→$1.5M(2021)→$1.0M(2022)→$803K(2023)→$652K(2024)

YoY Change:+0.2%

5yr CAGR:+1.6%

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

API Supply Chain13 active DMFs5 inactive

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

OLON SPATIMOLOL MALEATE

DMF 66441986

PCASTIMOLOL MALEATE

DMF 69831987

TAPI NL BVTIMOLOL MALEATE

DMF 72641987

FDC LTDTIMOLOL MALEATE USP

DMF 98391992

EXCELLA GMBH AND CO KGTIMOLOL MALEATE

DMF 155162001

SYN-TECH CHEM AND PHARM CO LTDTIMOLOL MALEATE USP

DMF 230092009

CENTAUR PHARMACEUTICALS PVT LTDTIMOLOL MALEATE USP

DMF 236302010

PCASTIMOLOL MALEATE (7125)

DMF 293422015

FAREVA LA VALLEETIMOLOL MALEATE

DMF 320642019

SYN-TECH CHEM AND PHARM CO LTDTIMOLOL MALEATE (TMM)

DMF 364282022

MICRO LABS LTDTIMOLOL MALEATE USP

DMF 372282022

GLOBAL CALCIUM PRIVATE LTDTIMOLOL MALEATE USP

DMF 396352024

C-SQUARED PHARMA LTDTIMOLOL MALEATE

DMF 428162025

SUMITOMO CHEMICAL CO LTDInactiveTIMOLOL MALEATE

DMF 82261989

SUZHOU NUMBER 1 PHARMACEUTICAL FACTORYInactiveTIMOLOL MALEATE USP

DMF 86491990

VIALE FULVIO TESTIInactiveTIMOLOL MALEATE

DMF 109001994

DEGUSSA AG WERK RADEBEULInactiveTIMOLOL MALEATE

DMF 122341996

SIFAVITOR SPAInactiveTIMOLOL MALEATE

DMF 147502000

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 19, 2013	SUPPL -5	View Letter (PDF)
Jun 10, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

RLDAT2

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 4, 2004

No patent or exclusivity listings for this strength.