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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

121 trials from ClinicalTrials.gov — 1 recruiting, 98 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients NCT04007276	Phase 4	Not Yet Recruiting	Tulane University	60	2026-11-10 → 2036-06-01
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma NCT00869141	Phase 4	Completed	University of California, Los Angeles	52	2009-03 → 2013-03
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension NCT01309204	Phase 3	Completed	Alcon Research	1,184	2011-05 → 2013-01
Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab NCT00864838	Phase 2	Completed	University of Sao Paulo	56	2008-06 → 2009-03
Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension NCT01687426	Phase 1	Completed	Eye Therapies, LLC	15	2012-09 → 2012-12
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension NCT00332345	Phase 2	Completed	Allergan	73	1999-07 → 1999-08
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects NCT00735449	Phase 4	Completed	Allergan	204	2008-07 → 2009-12
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension NCT01978600	Phase 4	Completed	Alcon Research	89	2013-10 → 2014-03
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa NCT00661479	Phase 1/2	Completed	Allergan	21	2008-07 → 2010-05
Randomized, Double-blind, Multiple-site, Placebo-controlled, Parallel-design Study in Patients With Moderate to Severe Facial Erythema Associated With Rosacea NCT02289352	Phase 3	Completed	Actavis Inc.	462	2014-07 → 2014-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$12.28

per ml

Lowest NADAC/Unit

$10.27

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314014405BRIMONIDINE TARTRATE 0.15% DRP	$12.28	ML	Generic	—	2026-06-17
61314014410BRIMONIDINE TARTRATE 0.15% DRP	$10.62	ML	Generic	—	2026-06-17
61314014415BRIMONIDINE TARTRATE 0.15% DRP	$10.27	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$56.34

Highest Price

$163.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61314-0144-05BRIMONIDINE TARTRATE 0.15% SOLN,OPH	$56.34	FSS	Sandoz, Inc.	08/14/2028
61314-0144-10BRIMONIDINE TARTRATE 0.15% SOLN,OPH	$109.93	FSS	Sandoz, Inc.	08/14/2028
61314-0144-15BRIMONIDINE TARTRATE 0.15% SOLN,OPH	$163.89	FSS	Sandoz, Inc.	08/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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.