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NDA

BRIMONIDINE TARTRATE | N021764 | SANDOZ 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

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

4 letters from Drugs@FDA

Date	Submission	Document
Nov 24, 2025	SUPPL -12	View Letter (PDF)
Mar 28, 2012	SUPPL -5	View Letter (PDF)
Aug 6, 2010	SUPPL -2	View Letter (PDF)
May 25, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.15%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 22, 2006

No patent or exclusivity listings for this strength.