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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	54
Patent Applications:	5,311
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	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	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 BRINZOLAMIDE

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

BRINZOLAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brinzolamide

Introduction to Brinzolamide

Brinzolamide is a carbonic anhydrase inhibitor used primarily in the treatment of ocular hypertension and open-angle glaucoma. It is available in various formulations, including eye drops and fixed combinations with other glaucoma medications.

Market Size and Growth

The global market for Brinzolamide API is projected to experience significant growth over the coming years. Here are some key metrics:

• Current Market Size: The Brinzolamide API market was estimated to be worth several million USD in 2023[1][3].
• Forecasted Growth: The market is expected to grow at a notable CAGR, with projections indicating a substantial increase in value by 2030[1][3].
• Global Pharmaceutical Market Context: The broader pharmaceutical market, valued at $1.475 trillion in 2022, is growing at a CAGR of 5% over the next six years, providing a favorable backdrop for the growth of specific segments like Brinzolamide[1].

Key Players

The Brinzolamide market is dominated by several key players, each contributing to the market's dynamics and growth:

• PHARMATHEN SA
• DUKE CHEM SA
• BIOCON LTD
• SCI PHARMTECH INC
• INDOCO REMEDIES LTD
• NEULAND LABORATORIES LTD
• INDUSTRIALE CHIMICA SRL
• ICROM SRL[1].

Market Segmentation

The Brinzolamide market is segmented based on several criteria:

By Type

• Purity ≥ 99%
• Purity < 99%[1].

By Application

• Eye Drops: This is the primary application, with Brinzolamide being used in various concentrations (e.g., 1% and 10mg/ml)[4].
• Others: This includes fixed combinations with other medications like timolol and brimonidine[5].

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[4].

Financial Trajectory

Revenue Forecast

The Brinzolamide Eye Drop Market, a significant segment of the Brinzolamide API market, is anticipated to reach substantial revenue by 2031. The market is expected to grow exponentially, driven by increasing demand for effective glaucoma treatments[4].

Cost-Effectiveness

Studies have shown that Brinzolamide can be a cost-saving alternative to other glaucoma medications like dorzolamide. The smaller drop size of Brinzolamide allows for more therapy days per bottle, reducing direct medical costs for patients and third-party payers[2].

Competitive Landscape

The competitive landscape is characterized by intense competition among key players. Companies like Novartis Pharmaceuticals UK Ltd, Mylan, Accord Healthcare Limited, and others are profiled in market reports, highlighting their product portfolios, financial statements, and strategic market approaches[4].

Drivers and Restraints

Drivers

• Increasing Prevalence of Glaucoma: The rising incidence of glaucoma and ocular hypertension drives the demand for effective treatments like Brinzolamide.
• Advancements in Formulations: The development of fixed combinations and improved formulations enhances the efficacy and tolerability of Brinzolamide, attracting more patients and prescribers.
• Cost-Effectiveness: The economic benefits of using Brinzolamide over other medications are a significant driver, especially in regions with stringent healthcare budgets[2][4].

Restraints

• Side Effects: While generally well-tolerated, Brinzolamide can cause side effects like stinging and blurred vision, which may deter some patients.
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials can slow market growth.
• Competition: The presence of other effective glaucoma medications and fixed combinations can pose a challenge to the market share of Brinzolamide[5].

Market Outlook

Trends

• Fixed Combinations: The trend towards using fixed combinations of glaucoma medications, such as Brinzolamide/timolol and Brinzolamide/brimonidine, is expected to continue, offering better patient compliance and efficacy[5].
• Regional Growth: The Asia-Pacific region is anticipated to show significant growth due to an increasing patient population and improving healthcare infrastructure[4].

Opportunities

• Emerging Markets: Expanding into emerging markets where access to glaucoma treatments is limited presents a significant opportunity for growth.
• Innovative Formulations: Developing new formulations that enhance patient comfort and efficacy can further boost market share[4].

Challenges

• Patient Adherence: Ensuring patient adherence to treatment regimens remains a challenge, as ocular discomfort associated with eye drops can decrease compliance.
• Economic Constraints: Economic downturns or healthcare budget constraints can impact the market's financial trajectory[5].

Key Takeaways

• Market Growth: The Brinzolamide API and eye drop markets are expected to grow significantly over the next decade.
• Cost-Effectiveness: Brinzolamide is a cost-saving alternative to other glaucoma medications.
• Competitive Landscape: The market is highly competitive, with several key players vying for market share.
• Drivers and Restraints: Increasing glaucoma prevalence, advancements in formulations, and cost-effectiveness drive the market, while side effects and regulatory hurdles act as restraints.

FAQs

Q: What is the primary application of Brinzolamide? A: The primary application of Brinzolamide is in the treatment of ocular hypertension and open-angle glaucoma, primarily through eye drops.

Q: Which companies are the main players in the Brinzolamide API market? A: Key players include PHARMATHEN SA, DUKE CHEM SA, BIOCON LTD, SCI PHARMTECH INC, INDOCO REMEDIES LTD, NEULAND LABORATORIES LTD, INDUSTRIALE CHIMICA SRL, and ICROM SRL[1].

Q: How does Brinzolamide compare to dorzolamide in terms of cost? A: Brinzolamide is generally more cost-effective than dorzolamide due to its smaller drop size, which allows for more therapy days per bottle[2].

Q: What are the common side effects of Brinzolamide? A: Common side effects include stinging and blurred vision, although it is generally well-tolerated compared to other glaucoma medications[5].

Q: What is the forecasted growth rate for the Brinzolamide API market? A: The market is expected to grow at a notable CAGR over the forecast period from 2023 to 2030[1][3].

Sources

1. Valuates Reports: Brinzolamide API - Market, Report Size, Worth, Revenue, Growth...
2. PubMed: Cost-minimisation Study of Dorzolamide Versus Brinzolamide in the...
3. Market Research Intellect: Global Brinzolamide API Market Size, Trends and Projections
4. Market Research Intellect: Brinzolamide Eye Drop Market Size, Scope And Forecast Report
5. Science.gov: brinzolamide-timolol fixed combination: Topics by Science.gov