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. Five 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:	5
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
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
Watson Labs Inc	BRINZOLAMIDE	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	209406-001	Nov 27, 2020	AB	RX	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

Last updated: February 20, 2026

Brinzolamide is a carbonic anhydrase inhibitor used primarily for the treatment of glaucoma and ocular hypertension. Its market is influenced by regulatory approvals, patent status, competition, and evolving treatment guidelines.

Market Overview

Brinzolamide's primary indication is intraocular pressure reduction in glaucoma. It was first approved by the U.S. Food and Drug Administration (FDA) in 2005. It is marketed as Azopt by Alcon. The drug's global market was valued at approximately $350 million in 2022, with growth driven by increased glaucoma prevalence and adoption as part of combination therapy.

Regulatory Status and Approvals

• FDA Approval: 2005 for ocular hypertension and open-angle glaucoma.
• European Approval: 2004, marketed as Azopt.
• Other Markets: Approved in over 50 countries; approval timelines differ.

Patent exclusivity ended in 2019, opening market space for generics.

Competitive Landscape

Brinzolamide vs. Alternatives

Drug Class	Examples	Market Position	Patent Status
Carbonic anhydrase inhibitors	Brinzolamide, Dorzolamide	Brinzolamide holds ~60% market share in its segment (2022)	Brinzolamide patent expired 2019
Beta-blockers	Timolol	Widely used, lower cost	Patents expired long ago
Prostaglandin analogs	Latanoprost, Travoprost	Leading drugs, high efficacy	Patented formulations

Brinzolamide competes mainly with dorzolamide; generics have entered the market, pressuring prices.

Combination Products

Brinzolamide is combined with timolol (e.g., Azarga), which accounts for roughly 40% of its sales. These combinations are preferred for ease of administration and increased efficacy.

Pricing and Reimbursement Trends

• Brinzolamide: Originator price approximately $180 per bottle.
• Generics: Prices declined by 50-70% following patent expiry.
• Reimbursement: Highly dependent on country and healthcare system; reimbursement rates favor generic use.

Revenue Trends and Forecasts

Year	Market Size (USD millions)	CAGR (2022–2027)	Key Drivers
2022	350	4.2%	Growing glaucoma prevalence, combination therapy adoption
2023	365		Increased generics penetration, price competition
2027 (forecast)	440	4.8%	Expansion into emerging markets, improved diagnosis rates

The forecast considers increased access in Asia-Pacific and Latin America, where glaucoma diagnosis rates rise along with healthcare infrastructure. Patent expirations will sustain competitive pressures.

R&D and Pipeline Developments

Currently, no significant pipeline of brinzolamide derivatives is publicly disclosed. Research focuses on sustained-release formulations and combination therapies to improve compliance and efficacy.

Financial Impact of Patent Expiry

Patent expiry in 2019 led to a sharp decline in originator sales. Major pharmaceutical companies responded with:

• Launching generic versions.
• Expanding combination products.
• Engaging in price competition.

This reduced profit margins for originator manufacturers but opened new revenue streams for generics.

Regulatory and Policy Factors

Changes in healthcare policies that promote generic substitution enhance market penetration. Cost containment measures in Europe and North America favor lower-priced generics, impacting brand sales.

Key Market Players

• Alcon: Patent holder, leading innovator.
• Sandoz: Generic competitor.
• Taro: Generic manufacturer.

Market share consolidation is unlikely in the short term due to a fragmented generic landscape and regional regulatory differences.

Conclusion

Brinzolamide's market is mature, with growth driven mainly by generic competition and expanding access in emerging markets. Revenue is expected to grow modestly through 2027, influenced heavily by healthcare policy shifts and patient adoption of combination therapies.

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Key Takeaways

• Brinzolamide generated approximately $350 million globally in 2022.
• Patent expiry in 2019 prompted price reductions and increased generic competition.
• The drug competes mainly with dorzolamide, beta-blockers, and prostaglandins.
• Growth prospects include emerging markets and combination formulations.
• Price sensitivity is high; reimbursement policies favor generics.

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FAQs

Q1: How does patent expiry affect brinzolamide's market?
A: It leads to generic entry, reducing prices and shifting market share from the originator to competitors.

Q2: What are the main competitors of brinzolamide?
A: Dorzolamide, timolol, latanoprost, and combination products like Azarga.

Q3: Are there ongoing R&D efforts for brinzolamide?
A: No significant pipeline; efforts focus on formulation improvements and combination therapies.

Q4: How do healthcare policies impact the market?
A: Policies favoring generics and cost containment promote lower prices and higher market penetration.

Q5: What is the future market outlook for brinzolamide?
A: Modest growth driven by emerging markets and combination therapy adoption; revenues may reach $440 million by 2027.

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References

[1] Market data provided by IQVIA, 2022.
[2] FDA approval and patent timelines, 2005–2019.
[3] Global glaucoma epidemiology reports, 2022.
[4] Competitive landscape analysis, Novartis Pharma (2022).
[5] Pricing and reimbursement policies, OECD Reports, 2022.