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TIMOLOL MALEATE

NDA

TIMOLOL MALEATE | N020963 | SANDOZ INC

2 strengths0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

225 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 182 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH NCT07690397	Phase 4	Active	Tecnoquimicas	140	2026-06-10 → 2027-09-01
Efficacy and Safety of Topical Timolol in Secondary Intention Surgical Wounds Healing NCT07384767	Phase 2	Not Yet Recruiting	University of California, Davis	220	2026-10-01 → 2027-12-31
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
Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery NCT07036510	Phase 1/2	Recruiting	EyeD Pharma	42	2025-06-12 → 2027-01
Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy NCT07729189	N/A	Completed	CMH Multan Institute of Medical Sciences	210	2025-03-10 → 2025-09-10
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
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension NCT07168902	Phase 2	Completed	Bausch & Lomb Incorporated	252	2025-10-24 → 2026-05-18
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension NCT01978600	Phase 4	Completed	Alcon Research	89	2013-10 → 2014-03
Dorzolamide-timolol Drops With Injections to Treat AMD, RVO or DME.NCT02571972	Phase 2	Completed	Wills Eye	14	2015-02-01 → 2015-12-20

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

Highest NADAC/Unit

$10.07

per ml

Lowest NADAC/Unit

$6.99

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314022505TIMOLOL 0.5% GFS GEL-SOLUTION	$10.07	ML	Generic	—	2026-08-19
61314022405TIMOLOL 0.25% GEL-SOLUTION	$6.99	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 | 2 NDCs (2 FSS)

Lowest Price

$50.30

Highest Price

$50.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61314-0224-05TIMOLOL MALEATE 0.25% GEL,OPH	$50.30	FSS	Sandoz, Inc.	08/14/2028
61314-0225-05TIMOLOL MALEATE 0.5% GEL,OPH	$50.30	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data for Timolol Maleate (2024)

Total Spending

$9.3M

Total Claims

28,017

Beneficiaries

9,480

Avg Cost/Unit

$3.64

Spending Trend

$171K(2020)→$5.9M(2021)→$8.1M(2022)→$9.7M(2023)→$9.3M(2024)

YoY Change:-27.2%

5yr CAGR:-12.8%

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

4 letters from Drugs@FDA

Date	Submission	Document
May 29, 2024	SUPPL -15	View Letter (PDF)
Jun 14, 2007	SUPPL -10	View Letter (PDF)
Jul 8, 2003	SUPPL -7	View Letter (PDF)
Oct 21, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.25% BASE

RLDAB

0 patents0 exclusivities▴

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Approved: Oct 21, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 0.5% BASE

RLDAB

0 patents0 exclusivities▾

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Approved: Oct 21, 1998