Brimonidine tartrate; brinzolamide - Generic Drug Details

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

Brimonidine tartrate; brinzolamide is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; brinzolamide has fifty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for brimonidine tartrate; brinzolamide

International Patents:	51
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brimonidine tartrate; brinzolamide
DailyMed Link:	brimonidine tartrate; brinzolamide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for brimonidine tartrate; brinzolamide

Constraining patent/regulatory exclusivity:

9,421,265

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for brimonidine tartrate; brinzolamide

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

Sponsor	Phase
Alcon Research	Phase 2
Hermann Eye Center	N/A
Alcon Research	N/A

See all brimonidine tartrate; brinzolamide clinical trials

Pharmacology for brimonidine tartrate; brinzolamide

Drug Class	Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for brimonidine tartrate; brinzolamide

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

S01EC	Carbonic anhydrase inhibitors
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; BRINZOLAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SIMBRINZA	Ophthalmic Suspension	brimonidine tartrate; brinzolamide	1%/0.2%	204251	1	2022-08-01

US Patents and Regulatory Information for brimonidine tartrate; brinzolamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	9,044,484		Y
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	9,421,265		Y

Expired US Patents for brimonidine tartrate; brinzolamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013	6,316,441

EU/EMA Drug Approvals for brimonidine tartrate; brinzolamide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Simbrinza	brinzolamide, brimonidine tartrate	EMEA/H/C/003698Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.	Authorised	no	no	no	2014-07-18

International Patents for brimonidine tartrate; brinzolamide

Country	Patent Number	Title	Estimated Expiration
Argentina	122017	COMPOSICIONES FARMACÉUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS DE BORATO-POLIOL
World Intellectual Property Organization (WIPO)	2010148190
Taiwan	201100103	Aqueous pharmaceutical compositions containing borate-polyol complexes
Cyprus	1117835
European Patent Office	3045164	COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Chile	2010000634	Composicion oftalmica multidosis que comprende un primer poliol seleccionado de manitol y/o sorbitol, un segundo poliol seleccionado de propilenglicol y/o glicerina, borato en cantidad menor a 0,5% en p/v, cloruro de benzalconio en concentracion de 0.0007%-0,0035% p/v y agua y uso para el tratamiento de la presion intraocular elevada.

Supplementary Protection Certificates for brimonidine tartrate; brinzolamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	C300683	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
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
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 and Brinzolamide

Last updated: August 1, 2025

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Introduction

The pharmaceutical landscape for ocular therapeutics continues to evolve, driven by technological advancements, regulatory shifts, and demographic trends. Two prominent drugs within this niche—brimonidine tartrate and brinzolamide—serve critical roles in managing glaucoma and ocular hypertension. Analyzing their market dynamics and financial trajectories offers strategic insights for stakeholders, including manufacturers, investors, and healthcare policymakers.

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Overview of Brimonidine Tartrate and Brinzolamide

Brimonidine Tartrate

Brimonidine tartrate is an alpha-2 adrenergic receptor agonist primarily prescribed for lowering intraocular pressure (IOP) in glaucoma and ocular hypertension. It was approved by the FDA in 1996 and has since seen widespread adoption owing to its efficacy and favorable side effect profile compared to older agents [1].

Brinzolamide

Brinzolamide is a carbonic anhydrase inhibitor (CAI), introduced later than brimonidine tartrate, with FDA approval in 2006. It reduces aqueous humor production, thus decreasing IOP. Its once-daily dosing and tolerability enhance compliance [2].

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Market Dynamics

1. Market Size and Growth Drivers

The global glaucoma therapeutics market is projected to reach approximately USD 5 billion by 2027, growing at a CAGR of around 4.8% [3]. Both brimonidine tartrate and brinzolamide contribute significantly to this figure.

Key drivers include:

• Aging Population: The increasing prevalence of glaucoma among individuals aged 60+ is a primary driver, driven by age-related optic nerve degeneration [4].

• Improved Diagnostics: Enhanced screening and diagnostic tools facilitate earlier detection and treatment initiation.

• Innovative Formulations: The introduction of fixed-dose combinations (FDCs) combining these agents with other drugs boosts adherence and expands market share.

2. Competitive Landscape

The arena is highly competitive, characterized by the dominance of multinational pharmaceutical giants such as Allergan (acquired by AbbVie), Santen, and Alcon. Generic formulations are prevalent, exerting price pressures [5].

Fixed-dose combinations like Azarga (brinzolamide and brimonidine) have gained market traction, emphasizing convenience and compliance, thus impacting the market shares of monotherapies.

3. Regulatory and Patent Trends

Patent expirations for key formulations have intensified generic competition, leading to downward pricing trends. Despite expiry-related price erosion, the demand for effective glaucoma treatments sustains profitability for innovator companies through lifecycle management strategies.

4. Geographic Market Variations

Developed regions like North America and Europe dominate market revenue due to higher healthcare expenditure and awareness. Emerging markets in Asia-Pacific and Latin America promise growth due to increasing glaucoma prevalence and expanding healthcare access.

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Financial Trajectory

1. Revenue and Profitability Trends

• Brimonidine Tartrate:

  Revenue growth is steady, bolstered by the introduction of FDCs (e.g., Combigan containing brimonidine and timolol). These formulations have enhanced prescribing patterns and patient compliance [6].

• Brinzolamide:

  Sales are driven by its role in combination therapies. Although newer alternatives (e.g., prostaglandin analogs) compete for monotherapy, brinzolamide remains relevant, especially in patients intolerant to prostaglandins [7].

2. R&D and Pipeline Development

Incremental R&D efforts focus on novel delivery systems (e.g., sustained-release implants), aiming to improve adherence and efficacy. Some companies are exploring preservative-free formulations to cater to sensitive patients, potentially opening new revenue streams.

3. Impact of Market Penetration Strategies

Expiration of patents has catalyzed the entry of generics, compressing margins but expanding volume sales. Strategic alliances and licensing also play roles in extending product lifecycles and expanding geographic reach.

4. Future Financial prospects

Indicators suggest moderate growth prospects:

• The aging global population maintains a stable demand.

• Innovation in fixed-dose formulations and delivery systems could elevate sales.

• Competitive pricing from generics could temper revenue growth but enhance overall market penetration.

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Market Challenges and Opportunities

Challenges

• Pricing Pressures: As generics flood the market, revenue margins decline, necessitating cost-efficient manufacturing and marketing strategies.

• Pricing and Reimbursement Policies: Healthcare reforms aimed at cost containment pose risks to profitability.

• Alternative Therapies: Emergence of new classes of drugs and approaches (e.g., minimally invasive surgeries) threaten long-term market share.

Opportunities

• Combination Therapies: FDCs improve adherence, expanding market base.

• Personalized Medicine: Tailoring treatments based on genetic markers could optimize outcomes and foster premium pricing.

• Global Expansion: Growing markets in Asia-Pacific and Latin America offer high-volume growth potential.

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Conclusion

The market for brimonidine tartrate and brinzolamide remains resilient, underpinned by demographic trends and therapeutic necessity. While patent expirations introduce challenges, strategic adoption of combination therapies and innovation in delivery systems are promising avenues for sustained financial success. Companies capable of adapting to regulatory, competitive, and technological shifts will likely sustain favorable trajectories in this evolving landscape.

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Key Takeaways

• The global glaucoma therapeutics market offers moderate growth, driven chiefly by aging populations and increased awareness.

• Fixed-dose combinations incorporating brimonidine tartrate and brinzolamide are driving market share and improving patient adherence.

• Patent expirations have increased generic penetration, exerting downward pressure on prices but expanding volume-based revenues.

• Innovation in drug delivery and formulations presents growth opportunities despite competitive pressures.

• Geographic expansion into emerging markets remains a strategic priority for increasing revenues.

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FAQs

1. What are the main competitive advantages of brimonidine tartrate and brinzolamide?
Brimonidine offers rapid IOP reduction with neuroprotective properties, while brinzolamide is effective with once-daily dosing and favorably tolerated. Their combination enhances efficacy, compliance, and reduces polypharmacy.

2. How do patent expirations impact the financial outlook for these drugs?
Patent expirations facilitate generic entry, leading to price reductions but potentially increasing overall sales volume. Companies may offset margins through increased market share and formulation innovations.

3. Are there any emerging alternatives threatening these drugs?
Yes. New drug classes like prostaglandin analogs and minimally invasive surgical procedures are competing for first-line therapy, which could affect demand for brimonidine and brinzolamide.

4. What role do fixed-dose combinations play in the market?
FDCs improve patient adherence, reduce treatment complexity, and often command premium pricing. They are central to market growth strategies for these drugs.

5. Which regions offer the most promising growth opportunities?
While North America and Europe dominate revenues, Asia-Pacific and Latin America present substantial growth potential owing to rising glaucoma prevalence and expanding healthcare infrastructure.

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References

[1] FDA. Brimonidine Tartrate Prescribing Information. 1996.
[2] FDA. Brinzolamide Prescribing Information. 2006.
[3] MarketsandMarkets. Glaucoma Drugs Market Analysis. 2022.
[4] Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. British Journal of Ophthalmology. 2006.
[5] IMS Health. Ophthalmic Pharmaceutical Market Trends. 2021.
[6] Allergan. Combigan Prescribing Information. 2017.
[7] Alcon. Azopt (brinzolamide ophthalmic suspension) Product Monograph. 2019.