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Last Updated: December 22, 2024

BRIMONIDINE TARTRATE; BRINZOLAMIDE - Generic Drug Details

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What are the generic sources for brimonidine tartrate; brinzolamide and what is the scope of patent protection?

Brimonidine tartrate; brinzolamide is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; brinzolamide has fifty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for BRIMONIDINE TARTRATE; BRINZOLAMIDE

International Patents:	51
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE; BRINZOLAMIDE
DailyMed Link:	BRIMONIDINE TARTRATE; BRINZOLAMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Generic Entry Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe Dosage: SUSPENSION/DROPS;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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

Sponsor	Phase
Alcon Research	Phase 2
Hermann Eye Center	N/A
Alcon Research	N/A

See all BRIMONIDINE TARTRATE; BRINZOLAMIDE clinical trials

Pharmacology for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Drug Class	Carbonic Anhydrase Inhibitor alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Carbonic Anhydrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SIMBRINZA	Ophthalmic Suspension	brimonidine tartrate; brinzolamide	1%/0.2%	204251	1	2022-08-01

US Patents and Regulatory Information for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Simbrinza	brinzolamide, brimonidine tartrate	EMEA/H/C/003698 Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.	Authorised	no	no	no	2014-07-18
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1117835		⤷ Subscribe
China	104707145	Aqueous pharmaceutical compositions containing borate-polyol complexes	⤷ Subscribe
Lithuania	3045164		⤷ Subscribe
European Patent Office	3437634	COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2010148190		⤷ Subscribe
Portugal	3045164		⤷ Subscribe
Denmark	2722035		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BRIMONIDINE TARTRATE; BRINZOLAMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	300683	Netherlands	⤷ Subscribe	PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	14C0056	France	⤷ Subscribe	PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	C300683	Netherlands	⤷ Subscribe	PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014/041	Ireland	⤷ Subscribe	PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293	2014C/042	Belgium	⤷ Subscribe	PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293	92462	Luxembourg	⤷ Subscribe	PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

BRIMONIDINE TARTRATE; BRINZOLAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Brimonidine Tartrate and Brinzolamide

Introduction to Brimonidine Tartrate and Brinzolamide

Brimonidine tartrate and brinzolamide are key components in ophthalmic solutions used primarily for the treatment of glaucoma and ocular hypertension. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

Increasing Prevalence of Ocular Conditions

The rising prevalence of glaucoma and other ocular conditions drives the demand for effective treatments like brimonidine tartrate and brinzolamide. As the global population ages, the incidence of these conditions is expected to increase, thereby boosting the market for these drugs[4].

Growing Awareness of Eye Health

Enhanced awareness of eye health and the importance of early diagnosis are significant drivers. Public health campaigns and educational initiatives have led to more people seeking medical attention for eye-related issues, which in turn increases the demand for brimonidine tartrate and brinzolamide eye drops[1].

Advances in Drug Delivery Systems

Developments in drug delivery systems offer opportunities for improved formulations of brimonidine tartrate and brinzolamide. New technologies can enhance the efficacy, safety, and patient compliance of these medications, making them more attractive to both patients and healthcare providers[1].

Market Restraints

Economic and Regulatory Hurdles

Economic and regulatory challenges can hinder the growth of the market. High development costs, stringent regulatory approvals, and pricing pressures can make it difficult for pharmaceutical companies to invest in and market these drugs effectively[1].

Competitive Landscape

The ophthalmic drug market is highly competitive, with several established players. Companies like Merck KGaA, Allergan plc, and Novartis AG dominate the market, making it challenging for new entrants to gain significant market share[4].

Market Opportunities

Growing Geriatric Population

The rapidly growing geriatric population is a significant opportunity for the market. Older adults are more prone to ocular conditions, and thus, the demand for brimonidine tartrate and brinzolamide is expected to rise[1].

Mergers, Acquisitions, and Partnerships

Increasing mergers, acquisitions, and partnerships in the biopharmaceutical sector can drive innovation and growth. For example, the business combination between Oculis and European Biotech Acquisition Corp aims to drive innovations in ophthalmology, including the development of new eye drop formulations[4].

Market Challenges

International Market Fluctuations

International market fluctuations can impact the distribution and pricing of brimonidine tartrate and brinzolamide. Economic instability in key markets can affect the demand and supply chain, leading to challenges in maintaining a stable market presence[1].

Regulatory Compliance

Regulatory hurdles, such as those outlined by the FDA, must be navigated carefully. Compliance with bioequivalence studies and other regulatory requirements is essential for the approval and continued sale of these drugs[3].

Financial Trajectory

Market Size and Growth

The global glaucoma eye drops market, which includes brimonidine tartrate and brinzolamide, is estimated to be valued at US$ 1,666.3 million in 2023 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 7.3% from 2023 to 2030, reaching US$ 2,725.4 million by 2030[4].

Cost-Effectiveness Analysis

Studies have shown that while brimonidine tartrate is effective in lowering intraocular pressure, it may not always be the most cost-effective option. For instance, a pharmacoeconomic analysis indicated that bimatoprost was more cost-effective than brimonidine tartrate in terms of the cost per millimeter of mercury (mmHg) reduction in intraocular pressure[2].

Product Launches and Innovations

Recent product launches, such as the brimonidine tartrate and timolol maleate ophthalmic solution by Upsher-Smith Laboratories, LLC, highlight the ongoing innovation in this market. These new formulations aim to improve efficacy and patient compliance, which can positively impact the financial trajectory of these drugs[4].

Competitive Assessment and Intelligence

Market Share Analysis

The market share analysis reveals a competitive landscape with several major players. Companies like Allergan plc, Novartis AG, and Teva Pharmaceutical Industries Ltd. hold significant market shares. Understanding the competitive strategies, product ranges, and regulatory approvals of these companies is crucial for new entrants and existing players alike[1].

Product Development and Innovation

The focus on product development and innovation is a key aspect of the market. Companies are investing in research and development to improve the formulations and delivery systems of brimonidine tartrate and brinzolamide. This includes the development of combination products and the use of advanced technologies to enhance drug delivery[1].

Clinical Studies and Efficacy

Efficacy in Lowering IOP

Clinical studies have demonstrated the efficacy of brimonidine tartrate in lowering intraocular pressure (IOP) with minimal effects on cardiovascular and pulmonary parameters. Brimonidine tartrate ophthalmic solution has been shown to be comparable to other treatments like ALPHAGAN® in reducing IOP in patients with open-angle glaucoma or ocular hypertension[5].

Safety and Acceptability

The safety and acceptability of brimonidine tartrate have been evaluated in several clinical studies. These studies indicate that brimonidine tartrate is well-tolerated and effective in managing ocular conditions, making it a preferred treatment option for many patients[5].

Regulatory Environment

FDA Guidance

The FDA provides guidance on the development and approval of ophthalmic solutions containing brimonidine tartrate and brinzolamide. This includes recommendations for bioequivalence studies and clinical endpoint designs to ensure the safety and efficacy of these drugs[3].

Key Takeaways

The market for brimonidine tartrate and brinzolamide is driven by the increasing prevalence of ocular conditions, growing awareness of eye health, and advances in drug delivery systems.
Economic and regulatory hurdles, along with a competitive landscape, pose significant challenges.
The growing geriatric population and increasing mergers, acquisitions, and partnerships offer opportunities for growth.
The financial trajectory is positive, with the global glaucoma eye drops market expected to grow at a CAGR of 7.3% from 2023 to 2030.
Clinical studies highlight the efficacy and safety of brimonidine tartrate in managing ocular conditions.

FAQs

What are the primary uses of brimonidine tartrate and brinzolamide?

Brimonidine tartrate and brinzolamide are primarily used to treat glaucoma and ocular hypertension by lowering intraocular pressure.

How does the competitive landscape impact the market for these drugs?

The competitive landscape, dominated by major pharmaceutical companies, influences market share, pricing, and innovation. New entrants must navigate this competitive environment to gain market traction.

What are the key drivers of the market for brimonidine tartrate and brinzolamide?

Key drivers include the increasing prevalence of ocular conditions, growing awareness of eye health, and advances in drug delivery systems.

How do regulatory requirements affect the market?

Regulatory requirements, such as those set by the FDA, impact the development, approval, and distribution of brimonidine tartrate and brinzolamide. Compliance with these regulations is essential for market success.

What is the expected growth of the global glaucoma eye drops market?

The global glaucoma eye drops market is expected to grow at a CAGR of 7.3% from 2023 to 2030, reaching US$ 2,725.4 million by 2030.

Sources

360iResearch: Brimonidine Tartrate Eye Drops Market Size & Share 2025-2030.
PubMed: A pharmacoeconomic analysis to determine the relative cost-effectiveness of bimatoprost and brimonidine.
FDA: Draft Guidance on Brimonidine Tartrate; Brinzolamide.
Coherent Market Insights: Glaucoma Eye Drops Market Size, Trends And Forecast To 2030.
Drugs.com: Brimonidine: Package Insert / Prescribing Information.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.