Viewing data from:

LUMIFY PRESERVATIVE FREE

NDA

BRIMONIDINE TARTRATE | N218424 | BAUSCH AND LOMB INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)TodayIPRPTAB Challenge

2027

2028

2029

2030

Today

8293742

Jul. 14, 2030IPR

9259425

Jul. 14, 2030IPR

11596600

Jul. 27, 2029IPR

PTAB Proceedings

3 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-00146	9259425	IPR	Slayback Pharma LLC	Terminated-Settled	2021-11-04	—
IPR2022-00142	8293742	IPR	Slayback Pharma LLC et al.	Terminated-Settled	2021-11-04	2025-08-13
IPR2024-00563	11596600	IPR	Dr. Reddy's Laboratories S.A. et al.	Terminated-Settled	2024-02-21	2024-09-10

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 Chain12 active DMFs1 inactive

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

FARMAK ASBRIMONIDINE TARTRATE

DMF 155852001

MEDICHEM SABRIMONIDINE TARTRATE

DMF 156012001

PIRAMAL PHARMA LTDBRIMONIDINE TARTRATE

DMF 175882004

FDC LTDBRIMONIDINE TARTRATE USP

DMF 208552007

INDOCO REMEDIES LTDBRIMONIDINE TARTRATE USP

DMF 221662008

SYMED LABS LTDBRIMONIDINE TARTRATE

DMF 222302008

C-SQUARED PHARMA LTDBRIMONIDINE TARTRATE

DMF 225102009

CENTAUR PHARMACEUTICALS PVT LTDBRIMONIDINE TARTRATE USP

DMF 238802010

SIEGFRIED GRAFTON INCBRIMONIDINE TARTRATE

DMF 242132010

UNICHEM LABORATORIES LTDBRIMONIDINE TARTRATE

DMF 250512011

MICRO LABS LTDBRIMONIDINE TARTRATE USP

DMF 343622019

MAITHRI DRUGS PRIVATE LTDBRIMONIDINE TARTRATE USP

DMF 365952021

LUPIN LTDInactiveBRIMONIDINE TARTRATE

DMF 252592011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 22, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025%

RLD

3 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 19, 2024

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8293742	Jul 14, 2030	—	—	—	—
9259425	Jul 14, 2030	—	—	—	—
11596600	Jul 27, 2029	—	—	—	—