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BRIMONIDINE TARTRATE

ANDA

BRIMONIDINE TARTRATE | A216361 | DR REDDYS LABORATORIES SA

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BAUSCH & LOMB, INC. et al v. SLAYBACK PHARMA LLC et al 3:2021cv16766 2 patentsANDA 216361Brimonidine tartrate	D.N.J.	2021-09-10	Terminated 2024-11-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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
Mar 7, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Feb 16, 2024

No patent or exclusivity listings for this strength.