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. Seven 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:	3
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	3,437
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/000267 Azopt 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)
Norway	923948

Supplementary Protection Certificates for AZOPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0527801	3/2003	Austria		PRODUCT NAME: BRINZOLAMIDUM; NAT. REGISTRATION NO/DATE: EU/1/00/129/01-02 20000309; FIRST REGISTRATION: LI 55236 19991217
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	CA 2009 00014	Denmark

AZOPT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ophthalmic Drugs: Focus on Azopt

Market Overview of Ophthalmic Drugs

The global ophthalmic drugs market is experiencing significant growth, driven by increasing prevalence of ophthalmic diseases and an aging population. In 2022, the global market size was estimated at $31.4 billion and is projected to reach over $52.8 billion by 2031, growing at a CAGR of 6.2% from 2023 to 2031[1].

Key Drivers and Segments

Therapeutic Classes

The anti-VEGF segment dominates the market, primarily due to the rising incidence of retinal disorders such as diabetic retinopathy, macular edema, age-related macular degeneration (AMD), and retinal vein occlusion. Novel product launches and advancements in technology, like the Multivalent Polymer Technology and Novel Anti-VEGF Antibody Conjugate Platform, are expected to further fuel this segment[1].

Regional Markets

North America is anticipated to hold the leading market share during the forecast period, while the Asia Pacific region is expected to grow at the fastest CAGR due to high disease prevalence, the emergence of local companies, and a large patient pool[1].

Azopt: A Specific Ophthalmic Drug

What is Azopt?

Azopt (brinzolamide) is an ophthalmic drug used to treat glaucoma and ocular hypertension by reducing intraocular pressure.

Market Dynamics for Azopt

Indications and Usage

Azopt is prescribed for patients with open-angle glaucoma or ocular hypertension. Its effectiveness in reducing intraocular pressure makes it a valuable treatment option in the ophthalmic drugs market[4].

Competitive Landscape

The ophthalmic drugs market is highly competitive, with key players such as Alcon Vision LLC, Bausch Health Companies, Inc., and Novartis Pharmaceuticals Corporation. Azopt, being a branded drug, competes with other branded and generic ophthalmic medications. The branded drugs segment, which includes Azopt, held a significant share in 2023, but the generic drugs segment is expected to grow rapidly due to the cost-effectiveness of generic drugs and the expiry of branded drug patents[4].

Pricing and Affordability

The pricing of ophthalmic drugs, including Azopt, is influenced by consumer demand and health insurance coverage rather than production costs. As health insurance plans increasingly cover ophthalmic drugs, the out-of-pocket expenditure for patients has decreased, making drugs like Azopt more accessible. However, the entry of generic versions and increased competition can lead to lower prices over time, similar to the trend observed in other therapeutic classes like GLP-1 agonists and direct-acting antivirals (DAAs) for hepatitis C[3].

Financial Trajectory

Revenue and Market Share

While specific financial data for Azopt is not provided, the overall revenue from ophthalmic drugs in the U.S. market was estimated at $15.53 billion in 2023 and is expected to grow at a CAGR of 7.4% from 2024 to 2030. The branded drugs segment, which includes Azopt, is expected to continue its growth driven by frequent approvals and new product launches[4].

Impact of Generic Competition

As patents for branded ophthalmic drugs expire, the generic segment is anticipated to show the fastest growth. This trend could impact the revenue of branded drugs like Azopt, as generic versions become more cost-effective and widely available. However, the unique therapeutic benefits and strong brand presence of Azopt are likely to maintain its market position to some extent[4].

Regulatory and Clinical Developments

Approvals and Clinical Trials

The ophthalmic drugs market is supported by frequent approvals and new product launches. For instance, in 2023, Iveric Bio announced that its medication, IZERVAY, received a unique HCPCS J-code from the U.S. Centers for Medicare and Medicaid Services (CMS), which can set a precedent for other ophthalmic drugs, including Azopt, in terms of regulatory approvals and reimbursement[4].

Key Takeaways

• Market Growth: The global ophthalmic drugs market is growing at a CAGR of 6.2% from 2023 to 2031, driven by increasing prevalence of ophthalmic diseases and an aging population.
• Competitive Landscape: Azopt competes in a highly competitive market with both branded and generic ophthalmic drugs.
• Pricing Dynamics: Prices are influenced by consumer demand and health insurance coverage, with potential for price reduction as generic versions enter the market.
• Regulatory Environment: Frequent approvals and new product launches support market growth, while generic competition may impact branded drug revenues.

FAQs

Q: What is the current market size of the global ophthalmic drugs market? A: The global ophthalmic drugs market size was estimated at $31.4 billion in 2022[1].

Q: What is the projected growth rate of the global ophthalmic drugs market? A: The market is expected to grow at a CAGR of 6.2% from 2023 to 2031[1].

Q: Which segment dominates the ophthalmic drugs market? A: The anti-VEGF segment dominates the market due to the rising incidence of retinal disorders[1].

Q: How does health insurance impact the pricing of ophthalmic drugs like Azopt? A: Health insurance coverage reduces out-of-pocket expenditure for patients, making drugs more accessible, but prices are still influenced by consumer demand rather than production costs[3].

Q: What is the impact of generic competition on branded ophthalmic drugs like Azopt? A: Generic competition is expected to increase, driven by the expiry of branded drug patents, which could lead to lower prices and reduced revenue for branded drugs[4].

Sources

1. Transparency Market Research: Ophthalmic Drugs Market Size, Share & Industry Outlook, 2031
2. Azenta Investors: Azenta Reports Fourth Quarter and Full Year Fiscal 2024 Results
3. The American Journal of Managed Care: The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs
4. Grand View Research: U.S. Ophthalmic Drugs Market Size | Industry Report, 2030
5. PR Newswire: Azenta Reports Fourth Quarter and Full Year Fiscal 2024 Results