Brimonidine Tartrate

Reduces elevated intraocular pressure (IOP). Sold as Alphagan, Alphagan P, Qoliana, Mirvaso, Lumify and 1 more. Every FDA application for this active ingredient: 8 branded and 22 generic.

As of Nov 15, 2026, FDA lists 30 applications for Brimonidine Tartrate (sold as Alphagan, Alphagan P, Qoliana and others), first approved Sep 6, 1996, with 3 new uses approved and 0 published complete response letters.

First approved: Sep 6, 1996
Applications: 30
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $151M
First approved in the EU: Feb 20, 2014
First approved in Japan: Jan 18, 2012

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Brimonidine Tartrate	Part D	$99.7M	+2%	716,882
Alphagan P	Part D	$51.1M	-45%	37,137
Mirvaso	Part D	$324K	-18%	179

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BRIMONIDINE 0.2% EYE DROP: $0.566 per MLGeneric · +0% in a year
BRIMONIDINE 0.33% GEL PUMP: $13.84 per GMGeneric · -4% in a year
BRIMONIDINE TARTRATE 0.1% DROP: $8.16 per MLGeneric · -43% in a year
BRIMONIDINE TARTRATE 0.15% DRP: $10.81 per MLGeneric · -7% in a year
ALPHAGAN P 0.1% DROPS: $37.30 per MLBrand · 0% in a year
ALPHAGAN P 0.15% EYE DROPS: $39.82 per MLBrand · 0% in a year
MIRVASO 0.33% GEL PUMP: $21.47 per GMBrand · +0% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Treatment of ocular graft versus host diseaseOcugen, Inc. · designated Aug 3, 2017
Treatment of anterior ischemic optic neuropathy.AbbVie · designated Feb 7, 2000

Approvals in the EU (EMA)

First approved in the EU 209 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Mirvaso, new substanceGalderma S.A. (Netherlands Branch) · Feb 20, 2014

Approvals in Japan (PMDA)

First approved in Japan 184 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Aiphagan, new ingredientA drug with a new active ingredient indicated for the treatment of glaucoma and ocular hypertension when other glaucoma drugs are not sufficiently effective… · Senju Pharmaceutical Co., Ltd. · Jan 18, 2012

Clinical Trials

12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECHPrimary Open-Angle Glaucoma (POAG), Ocular Hypertension · Tecnoquimicas	Phase 4	Active, not recruiting	Jul 8, 2026
Upneeq vs. Lumify PtosisAcquired Ptosis · Duke University	Phase 4	Not yet recruiting	Feb 5, 2026
Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat GlaucomaGlaucoma · Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,	Phase 4	Recruiting	Oct 7, 2025
Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral NeuropathyChemotherapy Induced Peripheral Neuropathy · Tarian Pharma	Phase 2	Not yet recruiting	Jul 24, 2025
Retinal Ganglion Cell Neuroprotection Under Prostaglandin AnaloguesGlaucoma · Association for Innovation and Biomedical Research on Light and Image	—	Not yet recruiting	Jul 20, 2025
Brimonidine Eye Drops in the Prevention of Myopia ProgressionMyopia · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Phase 2	Recruiting	May 30, 2025
Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia PatientsPresbyopia · Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	Phase 2	Recruiting	Apr 29, 2025
Efficacy of Simbrinza and Rocklatan vs Cosopt and LatanoprostOpen Angle Glaucoma · Prairie Eye Center	Phase 4	Recruiting	Mar 19, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 6, 1996	AlphaganNDA 20613 · New molecular entity	Allergan	21	Discontinued
Mar 13, 1997	AlphaganNDA 20490 · New dosage form	Allergan	9	Discontinued
Mar 16, 2001	Alphagan PNDA 21262 · New dosage form	Abbvie	15	Marketed
May 28, 2003	Brimonidine TartrateANDA 76260	Bausch And Lomb Inc	0	Marketed
Sep 16, 2003	Brimonidine TartrateANDA 76254	Sandoz	0	Marketed
Sep 10, 2004	Brimonidine TartrateANDA 76372	Teva Parenteral	0	Discontinued
Aug 19, 2005	Alphagan PNDA 21770 · New dosage form	Abbvie	7	Marketed
Mar 14, 2006	Brimonidine TartrateANDA 76439	Rising	1	Marketed
May 22, 2006	QolianaNDA 21764 · New formulation or manufacturer	Sandoz	6	Marketed
Jan 30, 2008	Brimonidine TartrateANDA 78075	Sandoz	0	Marketed
Aug 23, 2013	MirvasoNDA 204708 · New dosage form	Galderma Labs LP	4	Marketed
Nov 18, 2014	Brimonidine TartrateANDA 91691	Regcon Holdings	1	Marketed
Dec 22, 2017	LumifyNDA 208144 · New formulation or manufacturer	Bausch And Lomb Inc	7	Marketed
Mar 11, 2019	Brimonidine TartrateANDA 208992	Somerset Theraps LLC	0	Marketed
Sep 23, 2021	Brimonidine TartrateANDA 209158	Padagis Israel	1	Marketed
Jan 31, 2022	Brimonidine TartrateANDA 78479	Apotex	1	Marketed
Dec 21, 2022	Brimonidine TartrateANDA 78480	Apotex	1	Marketed
Mar 29, 2023	Brimonidine TartrateANDA 215225	Alembic	0	Marketed
Aug 1, 2023	Brimonidine TartrateANDA 216909	Alembic	0	Marketed
Nov 22, 2023	Brimonidine TartrateANDA 217846	Micro Labs	0	Marketed
Feb 16, 2024	Brimonidine TartrateANDA 216361	Dr Reddys Labs SA	1	Marketed
Mar 4, 2024	Brimonidine TartrateANDA 203172	Sandoz	0	Marketed
Apr 19, 2024	Lumify Preservative FreeNDA 218424 · New formulation or manufacturer	Bausch And Lomb Inc	0	Marketed
Jun 12, 2024	Brimonidine TartrateANDA 216772	Upsher Smith Labs	1	Marketed
Aug 9, 2024	Brimonidine TartrateANDA 216906	Somerset Theraps LLC	0	Marketed
Aug 26, 2024	Brimonidine TartrateANDA 213215	Lupin	0	Marketed
Jul 30, 2025	Brimonidine TartrateANDA 217599	Upsher Smith Labs	0	Marketed
Mar 11, 2026	Brimonidine TartrateANDA 219219	Gland	0	Marketed
Apr 16, 2026	Brimonidine TartrateANDA 220398	Mankind Pharma	0	Marketed
May 7, 2026	Brimonidine TartrateANDA 218558	Micro Labs	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA