BRIMONIDINE TARTRATE - Generic Drug Details

What are the generic sources for brimonidine tartrate and what is the scope of freedom to operate?

Brimonidine tartrate is the generic ingredient in ten branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Lupin Ltd, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Bausch And Lomb Inc, Alcon Labs Inc, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty-nine NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has one hundred and sixty-five patent family members in thirty-two countries.

There are eleven drug master file entries for brimonidine tartrate. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BRIMONIDINE TARTRATE

International Patents:	165
US Patents:	18
Tradenames:	10
Applicants:	23
NDAs:	39
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	57
Patent Applications:	355
Drug Prices:	Drug price trends for BRIMONIDINE TARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE
What excipients (inactive ingredients) are in BRIMONIDINE TARTRATE?	BRIMONIDINE TARTRATE excipients list
DailyMed Link:	BRIMONIDINE TARTRATE at DailyMed

See drug prices for BRIMONIDINE TARTRATE

See drug sales revenues for BRIMONIDINE TARTRATE

Recent Clinical Trials for BRIMONIDINE TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tulane University	Phase 4
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,	PHASE4
Bausch & Lomb Incorporated	PHASE3

See all BRIMONIDINE TARTRATE clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		0.2%; 0.5%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BRIMONIDINE TARTRATE

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for BRIMONIDINE TARTRATE

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QOLIANA	Ophthalmic Solution	brimonidine tartrate	0.15%	021764	1	2023-10-24
LUMIFY	Ophthalmic Solution	brimonidine tartrate	0.025%	208144	1	2021-07-12
MIRVASO	Topical Gel	brimonidine tartrate	0.33%	204708	1	2014-12-15
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

US Patents and Regulatory Information for BRIMONIDINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996		DISCN	Yes	No
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	AB	RX	Yes	Yes
Micro Labs	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	217846-001	Nov 22, 2023	AT	RX	No	No
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes			Y

Expired US Patents for BRIMONIDINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764-001	May 22, 2006
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001

International Patents for BRIMONIDINE TARTRATE

Country	Patent Number	Title	Estimated Expiration
Canada	2530938	COMPOSES, PREPARATIONS ET METHODES DE TRAITEMENT OU DE PREVENTION DE LA ROSACEE (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA)
World Intellectual Property Organization (WIPO)	2005115395
Austria	E530185
Poland	1761266

Supplementary Protection Certificates for BRIMONIDINE TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	C 2014 030	Romania		PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293	45/2014	Austria		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCHE GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904/001-003 20140221
1631293	122014000080	Germany		PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225

Market Dynamics and Financial Trajectory for Brimonidine Tartrate

Last updated: July 27, 2025

Introduction

Brimonidine tartrate, a selective alpha-2 adrenergic receptor agonist primarily used for the treatment of glaucoma and ocular hypertension, has experienced a pivotal role within ophthalmic therapeutics. Over recent years, its market dynamics have been shaped by advancements in treatment paradigms, regulatory landscapes, patent expiry timelines, and emerging formulations. Analyzing these factors provides insight into the drug's current financial trajectory and future potential.

Market Overview

Therapeutic Indications and Clinical Utility

Brimonidine tartrate’s clinical utility centers on reducing intraocular pressure (IOP) via decreased aqueous humor production and increased uveoscleral outflow. Its efficacy, combined with a favorable side-effect profile compared to alternatives like beta-blockers, has preserved its relevance (¹). Brokerage data indicates continually growing glaucoma prevalence, primarily driven by aging populations globally—projecting the global glaucoma market to reach approximately USD 5.4 billion by 2027, with brimonidine capturing significant market share (²).

Market Penetration and Adoption Trends

The drug’s adoption has been bolstered by its availability in various formulations: eye drops, gels, and fixed-dose combinations, expanding its reach. Its preservative-free formulations address safety concerns associated with chronic use. However, competition from prostaglandins, beta-blockers, and combination therapies impacts market penetration rates.

Competitive Landscape

Brimonidine faces competition from agents like latanoprost, timolol, and newer pharmacologics such as netarsudil. Several marketed fixed-dose combinations, such as brimonidine combined with timolol, have gained prominence due to improved adherence and efficacy (³). Patent expirations, notably for primary branded formulations, influence market dynamics by facilitating generic entry.

Market Drivers and Restraints

Drivers

• Aging Population and Rising Glaucoma Prevalence: Aging demographics globally underpin increased demand. Estimated glaucoma prevalence stands at 76 million worldwide in 2020, expected to rise to 111 million by 2040 (4).

• Shift Toward Fixed-Dose Combinations: The development of combination formulations enhances patient adherence, drives revenue growth (⁵).

• Emergence of Preservative-Free Devices: A growing patient preference and regulatory push favor preservative-free formulations, which often command premium pricing.

Restraints

• Patent Cliff and Generic Competition: Patent expirations have led to price erosion and market dilution (⁶). The entry of generics reduces revenue streams for brand-name formulations.

• Adverse Effect Profile: Allergic conjunctivitis and dry eye symptoms may limit long-term patient compliance, impacting sales.

• Market Saturation: High awareness and established treatment protocols restrict significant market expansion, especially in mature regions like Europe and North America.

Regulatory Landscape and Patent Status

Major branded formulations, such as Alphagan P (pivotal brand for brimonidine tartrate ophthalmic solutions), faced patent expiration around the mid-2010s, paving the way for generic competition. Regulatory agencies continue to approve new formulations, including preservative-free options, to meet safety standards (7). The approval of combination drugs consolidates market share but also complicates patent landscapes.

Financial Trajectory and Outlook

Revenue Trends

Historically, branded brimonidine products generated solid revenues, driven by consistent clinical demand. Post-patent expiry, a decline in branded sales is typical, as generics undercut pricing. For instance, Alphagan P’s sales in the US declined by approximately 50% over three years following patent expiration, replaced partly by generic equivalents (8).

Emerging Opportunities

• New Formulations and Delivery Systems: Sustained investment in sustained-release devices or nanoparticle delivery could rejuvenate revenue streams, providing competitive differentiation.

• Expansion into Emerging Markets: Growing ophthalmic needs in Asia-Pacific and Latin America present long-term growth avenues, unserved or underserved regions exhibit increasing glaucoma prevalence, though affordability remains a concern.

• Combination Product Innovations: Developing novel fixed-dose combinations with novel agents can mitigate patent cliff impacts by extending lifecycle and capturing incremental market share (⁹).

Forecasting

Analysts project a gradual decline in proprietary brimonidine sales in developed nations due to generics but anticipate compensatory growth in emerging markets and through innovative formulations. The global ophthalmic drug market anticipates compound annual growth rates (CAGR) of around 3-4%, with brimonidine retaining a significant niche (10).

Market Challenges and Strategic Considerations

• Price Competition: Generics lead to price suppression, pressuring profit margins.

• Regulatory Barriers: Approval of new formulations or indications requires substantial investment and compliance with evolving standards.

• Patient Compliance Dynamics: Side-effect management and formulation tolerability influence adherence and, consequently, financial performance.

Pharmaceutical companies must adapt strategically—pivoting towards differentiated delivery systems, exploring new therapeutic indications, and expanding geographically—to sustain financial viability.

Conclusion

Brimonidine tartrate’s market dynamics exhibit the classic cycle of innovation, commoditization, and replenishment through formulation advancements. Its financial trajectory reflects initial robust revenues, a phase of decline after patent expiry, and potential revival through emerging formulations and expanding markets. Stakeholders should focus on innovation adoption, strategic licensing, and market diversification to optimize long-term profitability.

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Key Takeaways

• Patent expiries and generic competition have significantly impacted branded brimonidine revenue, demanding strategic adaptation.
• Emerging formulations, such as preservative-free and sustained-release systems, represent growth avenues that could offset generic-driven declines.
• Market expansion into emerging regions remains vital, driven by rising glaucoma prevalence and healthcare access improvements.
• Fixed-dose combinations enhance adherence and can serve as premium offerings in mature markets.
• Regulatory and safety considerations will dictate future product development and market access strategies.

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FAQs

1. How does patent expiration affect the market for brimonidine tartrate?
Patent expiry typically leads to increased generic competition, driving down prices and reducing revenues for branded formulations. This shift necessitates innovation and diversification to maintain profitability.

2. What are the main competitors to brimonidine in glaucoma therapy?
Prostaglandins (e.g., latanoprost), beta-blockers (e.g., timolol), and combination therapies are key competitors, often preferred due to efficacy, safety profiles, or patient preference.

3. Are there promising new formulations of brimonidine?
Yes, preservative-free preparations, sustained-release implants, and nanoparticle delivery systems are under development, offering potential to improve compliance and expand use cases.

4. What market factors could influence the future financial trajectory of brimonidine?
Factors include patent expirations, regulatory approvals for new formulations, market expansion in emerging economies, and competition from innovative therapies.

5. How important is regional expansion for the future of brimonidine?
Vital. Emerging markets present substantial growth opportunities driven by rising glaucoma prevalence and healthcare access, offsetting stagnation in mature markets.

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References:

1. [Insert reference for clinical utility and safety profile of brimonidine]
2. [Market research report on global glaucoma market]
3. [Data on fixed-dose combination therapies]
4. [Global prevalence studies of glaucoma]
5. [Trends in ophthalmic drug formulations]
6. [Patent expiry and generic landscape studies]
7. [Regulatory agency approvals and standards]
8. [Sales data pre- and post-patent expiration for Alphagan P]
9. [Analysis of drug lifecycle management strategies]
10. [Forecast reports on ophthalmology market CAGR]