Viewing data from:

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Istalol (2023)

Total Spending

$803K

Total Claims

1,574

Beneficiaries

410

Avg Cost/Unit

$78.36

Spending Trend

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

YoY Change:+0.9%

5yr CAGR:+3.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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.