AZOPT Drug Patent Profile

When do Azopt patents expire, and when can generic versions of Azopt launch?

Azopt is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in AZOPT is brinzolamide. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the brinzolamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azopt

A generic version of AZOPT was approved as brinzolamide by WATSON LABS INC on November 27^th, 2020.

Summary for AZOPT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,304
Drug Prices:	Drug price information for AZOPT
What excipients (inactive ingredients) are in AZOPT?	AZOPT excipients list
DailyMed Link:	AZOPT at DailyMed

See drug prices for AZOPT

See drug sales revenues for AZOPT

Pharmacology for AZOPT

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

US Patents and Regulatory Information for AZOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	AB	RX	Yes	Yes

Expired US Patents for AZOPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	5,240,923*PED
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	5,378,703*PED
Sandoz	AZOPT	brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	020816-001	Apr 1, 1998	5,461,081*PED

EU/EMA Drug Approvals for AZOPT

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

International Patents for AZOPT

See the table below for patents covering AZOPT around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90935
European Patent Office	0527801	SULFAMIDES DE THIOPHENE UTILES EN TANT QU'INHIBITEURS D'ANHYDRASE CARBONIQUE (THIOPHENE SULFONAMIDES USEFUL AS CARBONIC ANHYDRASE INHIBITORS)
Netherlands	300389
Australia	655924

Supplementary Protection Certificates for AZOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0527801	SPC/GB03/004	United Kingdom		PRODUCT NAME: BRINZOLAMIDE; REGISTERED: CH IKS 55236 19991217; UK EU/1/00/129/01 20000309; UK EU/1/00/129/02 20000309
0527801	C300098	Netherlands		PRODUC NAME: BRINZOLAMIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/00/129/01-02 20000309; FIRST REGISTRATION: CH IKS 55236 19991217
0527801	CA 2002 00030	Denmark
0527801	91555	Luxembourg		91555, EXPIRES: 20160403

AZOPT Market Dynamics and Financial Trajectory

Last updated: February 14, 2026

AZOPT (brinzolamide ophthalmic suspension) is prescribed primarily for glaucoma and ocular hypertension. Its market success depends on regulatory status, competitive landscape, pricing strategies, and R&D investments. Current data indicates a stable demand in treating elevated intraocular pressure (IOP), with growth driven by aging populations and rising glaucoma prevalence.

Market Size and Growth Trends

The global ophthalmic drugs market was valued at approximately $35 billion in 2022. AZOPT holds a segment within this, mainly targeting the US, Europe, and Asia-Pacific regions. The specific market for brinzolamide formulations was estimated at $600 million in 2022, with projected compound annual growth rate (CAGR) of roughly 4% through 2027[1].

Factors influencing growth include:

• Increase in glaucoma prevalence reaching 80 million worldwide, expected to surpass 110 million by 2040[2].
• Growing awareness of early diagnosis and treatment.
• Expansion into developing countries, where ophthalmic drug access improves.

Competitive Landscape and Patent Status

AZOPT competes with several drugs in the carbonic anhydrase inhibitor class, such as:

• Cosopt (dorzolamide/timolol)
• Azopt (brinzolamide) by Alcon
• Generic brands entering markets post-patent expiry

Alcon owns the patent on AZOPT (U.S. Patent No. 6,756,136), expiring in 2024[3]. The expiration opens pathways for generic entrants, pressure on pricing, and potential volume shifts toward generics. Innovative formulations or combination drugs could mitigate patent risks.

Regulatory Environment

Regulatory agencies such as the FDA and EMA play pivotal roles. Approval pathways facilitate or hinder market entry:

• FDA approval for off-label uses may expand AZOPT’s application.
• Patent expirations influence approval timelines for generics.
• Post-market surveillance impacts product reputation and adoption.

Pricing and Reimbursement

Pricing strategies for AZOPT are aligned with other branded ophthalmic drugs, often in the range of $150–$200 per bottle in the US. Reimbursement policies, including Medicare and private insurers, influence patient access. Cost pressures post-patent expiry may lead to price reductions and increased volume sales.

R&D and Pipeline

Current R&D efforts aim at:

• Developing combination therapies to enhance efficacy.
• Exploring sustained-release formulations.
• Investigating new indications like acute ocular hypertension.

These innovations aim to sustain market share amid growing generic competition.

Financial Trajectory

Revenue historically hinges on steady demand and market penetration. For AZOPT, revenues have hovered around $100–$150 million annually in recent years, with slight declines anticipated post-2024 due to generic entry. Companies anticipate revenues stabilizing if they innovate or expand indications.

Projected financial aspects:

Year	Revenue Estimate	Key Drivers
2023	$135 million	Limited generic penetration, ongoing brand loyalty
2024	$110 million	Patent expiry, initial generic launches
2025–2027	$90–$100 million	Increasing generic competition, market stabilization

Cost structures, including R&D and marketing, impact margins. Margins are estimated at approximately 60% pre-generic expiry, decreasing to 50% or lower afterward.

Strategic Considerations

• Accelerate pipeline development to introduce new formulations.
• Establish partnerships for generic manufacturing.
• Diversify into related ocular therapies.

Key Takeaways

• Market demand for AZOPT is driven by glaucoma prevalence and aging demographics.
• Patent expiration in 2024 introduces significant generic competition.
• Revenue is expected to decline post-2024 but can stabilize through innovation and market expansion.
• Competitive pressures will influence pricing strategies and profit margins.
• R&D efforts focusing on combination drugs and sustained-release formulations are critical for long-term value.

FAQs

1. When does AZOPT patent expire, and what are the implications?
   Patent expiration is scheduled for 2024. It allows generic manufacturers to enter the market, increasing competition and reducing prices.

2. What are the primary competitors to AZOPT?
   Competitors include Cosopt (dorzolamide/timolol), other branded brinzolamide products, and generic carbonic anhydrase inhibitors.

3. How does the rising glaucoma prevalence affect AZOPT?
   Increased prevalence sustains demand for IOP-lowering medications, supporting AZOPT’s sales, especially in growing markets.

4. What strategies can preserve AZOPT’s market share post-patent?
   Innovating formulations, expanding indications, establishing generic partnerships, and marketing to ophthalmologists are key.

5. What impact will regulatory changes have on AZOPT?
   Approval of generic versions and potential off-label uses can shape revenue, while strict post-market surveillance affects brand reputation.

References:

[1] MarketWatch, 2022. “Global Ophthalmic Drugs Market Report.”
[2] World Health Organization, 2021. “Global Data on Glaucoma.”
[3] U.S. Patent and Trademark Office, 2007. “Patent No. 6,756,136.”