BRINZOLAMIDE - Generic Drug Details

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

Brinzolamide is the generic ingredient in two branded drugs marketed by Sandoz, Bausch And Lomb, Padagis Us, and Watson Labs Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for brinzolamide. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BRINZOLAMIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	54
Patent Applications:	6,758
Drug Prices:	Drug price trends for BRINZOLAMIDE
What excipients (inactive ingredients) are in BRINZOLAMIDE?	BRINZOLAMIDE excipients list
DailyMed Link:	BRINZOLAMIDE at DailyMed

See drug prices for BRINZOLAMIDE

Recent Clinical Trials for BRINZOLAMIDE

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

Sponsor	Phase
Sun Pharmaceutical Industries Limited	Phase 3
Peking University	N/A
General Hospital of Athens Elpis	N/A

See all BRINZOLAMIDE clinical trials

Generic filers with tentative approvals for BRINZOLAMIDE

Applicant	Application No.	Strength	Dosage Form
		0.2MG,10MG	SUSPENSION/DROPS;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 BRINZOLAMIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BRINZOLAMIDE

S01EC	Carbonic anhydrase inhibitors
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BRINZOLAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	BRINZOLAMIDE	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204884-001	Aug 18, 2021	AB	RX	No	No
Watson Labs Inc	BRINZOLAMIDE	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	209406-001	Nov 27, 2020	AB	RX	No	No
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	AB	RX	Yes	Yes
Padagis Us	BRINZOLAMIDE	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	211914-001	Jul 28, 2023		DISCN	No	No

Expired US Patents for BRINZOLAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998

EU/EMA Drug Approvals for BRINZOLAMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Azopt	brinzolamide	EMEA/H/C/000267Azopt is indicated to decrease elevated intraocular pressure in:ocular hypertension;open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.	Authorised	no	no	no	2000-03-09

Market Dynamics and Financial Trajectory for Brinzolamide: A Strategic Analysis

Last updated: July 29, 2025

Introduction

Brinzolamide, a member of the carbonic anhydrase inhibitor class, has cemented its role in ophthalmology as a key component in managing glaucoma and ocular hypertension. Developed by Alcon and approved by the FDA in 2006, brinzolamide is primarily marketed as a topical eye drop, often utilized as adjunct therapy when intraocular pressure (IOP) control is inadequate. The compound’s unique pharmacological profile and the evolving landscape of glaucoma management shape its market trajectory. This analysis dissects the current market dynamics, anticipated growth drivers, competitive landscape, and financial outlook for brinzolamide over the coming years.

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Market Overview and Size

The global ophthalmic pharmaceuticals market was valued at approximately USD 19.6 billion in 2021 and is projected to surpass USD 30 billion by 2027, growing at a compound annual growth rate (CAGR) of around 6% (1). Within this segment, glaucoma medications account for a significant share, driven by the increasing prevalence of glaucoma—estimated at over 76 million globally—and the aging population. Brinzolamide primarily targets this segment, with a market share that, while relatively modest compared to first-line agents like prostaglandin analogs, remains vital due to its unique mechanism and tolerability profile.

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Market Drivers

1. Rising Prevalence of Glaucoma and Ocular Hypertension

The increasing global burden of glaucoma underpins the demand for effective IOP-lowering agents. According to the World Health Organization, glaucoma is the second leading cause of blindness worldwide, emphasizing the persistent need for diverse management options (2). As the population ages—especially in developed countries—incidence rates climb, fostering sustained demand for pharmacological therapies like brinzolamide.

2. Expanding Therapeutic Portfolio and Combination Therapies

While prostaglandin analogs dominate glaucoma treatment, combination therapies incorporating brinzolamide are gaining popularity. Fixed-dose combinations (FDCs), such as brinzolamide/brimonidine or brinzolamide/timolol, enhance patient adherence and optimize IOP reduction. Regulatory approvals and strategic partnerships for FDCs bolster market adoption (3).

3. Growing Awareness and Diagnosis Rates

Enhanced screening programs and increased awareness about eye health contribute to earlier diagnosis and initiation of treatment, further expanding the market for adjunct therapies like brinzolamide.

4. Favorable Pharmacological Profile

Brinzolamide’s favorable tolerability, minimal systemic absorption, and once or twice-daily dosing reinforce its utility in long-term management, supporting sustained market demand.

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Market Restraints

1. Dominance of First-Line Agents

Prostaglandin analogs such as latanoprost, bimatoprost, and travoprost command around 80% of the overall glaucoma medication market share, limiting opportunities for monotherapy sales of brinzolamide (4).

2. Competition from Alternative Drug Classes

Prostaglandin analogs, beta-blockers, alpha agonists, and emerging therapies (e.g., rho kinase inhibitors) create a highly saturated market, pressuring pricing and affecting profitability for brinzolamide.

3. Patent Expiry and Generic Competition

Although brinzolamide’s patent protection is still active, upcoming patent expirations threaten price erosion and market share, prompting companies to invest in new formulations and combinations to maintain competitiveness.

4. Side Effect Profiles and Patient Preferences

While well-tolerated, some patients experience adverse effects such as bitter taste, conjunctival hyperemia, or allergic reactions, which can influence treatment choices toward other agents.

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Competitive Landscape

Brinzolamide faces competition from:

• Betaxolol and other beta-blockers with established use.
• Prostaglandin analogs as first-line therapies.
• Combination products like Brimonidine/Brinzolamide (Simbrinza), which offer enhanced efficacy but face competition from other combination FDCs.

Key players include:

• Novartis (products like Cosopt, a dorzolamide/timolol FDC).
• Allergan (now AbbVie) with various combination formulations.
• Alcon, holding the primary patent for brinzolamide.

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Regulatory and Research Trajectory

Regulatory agencies remain supportive of ongoing research into brinzolamide, including novel formulations (e.g., sustained-release devices) and new indications such as retinal vascular disorders, although these remain experimental. The focus on combination formulations with improved bioavailability and reduced side effects indicates an innovation-driven market evolution.

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Financial Trajectory and Forecast

Revenue Projections

Considering the overall growth of the glaucoma therapeutics market and incremental uptake of combination therapies, brinzolamide’s revenues are expected to grow modestly over the next five years. A conservative CAGR of 4-6% is projected, driven by increased diagnosis rates and expanded use in combination products, despite intense competition from first-line agents.

Pricing Dynamics

Patent protections and brand recognition support premium pricing initially; however, imminent generic entry and market saturation are likely to exert downward pressure. Companies may adopt tiered pricing strategies, especially in emerging markets.

Investment in Innovation

To sustain growth, manufacturers are investing in:

• Formulation improvements: sustained-release devices.
• New combinations: targeting fixed-dose, simplified regimens.
• Biomarker-driven personalized medicine approaches to optimize treatment outcomes.

Market Entry and Expansion Strategies

Emerging markets represent high-growth opportunities due to increasing healthcare infrastructure and glaucoma awareness. Strategic licensing, local manufacturing, and tailored pricing will influence financial trajectories in these regions.

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Regulatory Outlook

Regulatory pathways remain supportive for fixed-dose combinations and new formulations. Increased approval of biosimilar and generic versions poses both threats and opportunities, compelling incumbents to innovate further. Continuous monitoring of regulatory landscapes across regions like the U.S., EU, and Asia-Pacific is vital for financial forecasts.

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Conclusion and Future Outlook

Brinzolamide's market is characterized by steady growth, driven primarily by the expanding prevalence of glaucoma, the adoption of combination therapies, and ongoing innovations in drug delivery systems. While facing stiff competition from prostaglandin analogs and other drug classes, its niche in adjunct therapy and favorable safety profile sustain its relevance. With strategic development and marketing efforts, interests are likely to shift toward combination products, sustained-release formulations, and expanding indications, securing its position in the evolving ophthalmic therapeutics landscape.

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Key Takeaways

• The global glaucoma market is poised for steady growth, underpinning brinzolamide's continued relevance.
• Competition from first-line agents constrains standalone sales, emphasizing the importance of combination therapies.
• Patent expirations and generic entries will pressure prices, catalyzing innovation in formulation and delivery.
• Emerging markets offer significant growth prospects, provided tailored strategies are employed.
• Future success depends on R&D investments in sustained-release formulations and new combination therapies to differentiate from existing treatments.

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FAQs

1. What are the main indications for brinzolamide?
Brinzolamide is primarily indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension, often as adjunct therapy.

2. How does brinzolamide compare to other glaucoma medications?
It offers a favorable safety profile and reduced systemic absorption compared to oral carbonic anhydrase inhibitors. However, its monotherapy efficacy is typically lower than prostaglandin analogs, making it more suitable as part of combination regimens.

3. What are the key factors influencing brinzolamide's market growth?
Increasing glaucoma prevalence, adoption of combination therapies, innovations in drug delivery, and expansion into emerging markets primarily drive growth.

4. How will patent expirations impact brinzolamide's market?
Patent expirations could lead to generic competition, exerting downward pressure on pricing and market share, incentivizing companies to develop new formulations and combination products.

5. Are there any promising new formulations of brinzolamide in development?
Yes, sustained-release eye drop formulations and novel combination products are under investigation to improve adherence and efficacy, presenting future growth opportunities.

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References

[1] Market Research Future, “Global Ophthalmic Drugs Market,” 2022.

[2] World Health Organization, “Prevalence of Glaucoma,” 2020.

[3] Food and Drug Administration, “Regulatory Approvals for Glaucoma Medications,” 2019.

[4] IQVIA, “Global Ophthalmic Market Insights,” 2021.