Viewing data from:

TIMOPTIC-XE

NDA

TIMOLOL MALEATE | N020330 | BAUSCH AND LOMB 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

No clinical trials found on ClinicalTrials.gov for this drug

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

8 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2018	SUPPL -32	View Letter (PDF)
Oct 13, 2015	SUPPL -29	View Letter (PDF)
Oct 4, 2011	SUPPL -27	View Letter (PDF)
May 1, 2006	SUPPL -24	View Letter (PDF)
May 1, 2006	SUPPL -22	View Letter (PDF)
Aug 12, 2004	SUPPL -19	View Letter (PDF)
Aug 12, 2004	SUPPL -18	View Letter (PDF)
Dec 24, 2003	SUPPL -17	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: Nov 4, 1993

No patent or exclusivity listings for this strength.

#002 — EQ 0.5% BASE

RLDAB

0 patents0 exclusivities▾

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | Approved: Nov 4, 1993