Brimonidine tartrate - Generic Drug Details

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

Brimonidine tartrate is the generic ingredient in ten branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Lupin Ltd, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Bausch And Lomb Inc, Alcon Labs Inc, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty-six NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has two hundred patent family members in thirty-two countries.

There are eleven drug master file entries for brimonidine tartrate. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for brimonidine tartrate

International Patents:	200
US Patents:	20
Tradenames:	10
Applicants:	22
NDAs:	36
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	54
Patent Applications:	2,555
Drug Prices:	Drug price trends for brimonidine tartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brimonidine tartrate
What excipients (inactive ingredients) are in brimonidine tartrate?	brimonidine tartrate excipients list
DailyMed Link:	brimonidine tartrate at DailyMed

See drug prices for brimonidine tartrate

See drug sales revenues for brimonidine tartrate

Recent Clinical Trials for brimonidine tartrate

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

Sponsor	Phase
Tulane University	Phase 4
Visus Therapeutics	Phase 3
Optall Vision	Phase 1

See all brimonidine tartrate clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		0.2%; 0.5%	SOLUTION; 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 brimonidine tartrate

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for brimonidine tartrate

Adrenergic alpha-2 Receptor Agonists

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for brimonidine tartrate

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUMIFY	Ophthalmic Solution	brimonidine tartrate	0.025%	208144	1	2021-07-12
MIRVASO	Topical Gel	brimonidine tartrate	0.33%	204708	1	2014-12-15
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.1%	021770	1	2006-12-20
ALPHAGAN P	Ophthalmic Solution	brimonidine tartrate	0.15%	021262	1	2006-11-03

US Patents and Regulatory Information for brimonidine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020490-001	Mar 13, 1997		DISCN	No	No
Allergan	ALPHAGAN	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	020613-001	Sep 6, 1996		DISCN	Yes	No
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,426,410
Apotex	BRIMONIDINE TARTRATE	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	078479-001	Jan 31, 2022	AT	RX	No	No
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	10,201,517		Y

Expired US Patents for brimonidine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	9,687,443*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	5,424,078*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	6,673,337*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021770-001	Aug 19, 2005	8,858,961*PED
Abbvie	ALPHAGAN P	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021262-001	Mar 16, 2001	5,424,078*PED

International Patents for brimonidine tartrate

Country	Patent Number	Title	Estimated Expiration
Hungary	E051833
Australia	2005220199
World Intellectual Property Organization (WIPO)	2006026215
Portugal	2815748
World Intellectual Property Organization (WIPO)	2015031183

Supplementary Protection Certificates for brimonidine tartrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	132014902284452	Italy		PRODUCT NAME: BRIMONIDINA(MIRVASO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/904/001-002-003, 20140221
1631293	C20140022 00150	Estonia		PRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
1631293	C 2014 030	Romania		PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
1631293	CR 2014 00031	Denmark		PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221

Brimonidine tartrate Market Analysis and Financial Projection Experimental

Brimonidine Tartrate: Market Dynamics and Financial Trajectory

Introduction

Brimonidine tartrate, an alpha-2 adrenergic receptor agonist, is widely used in ophthalmic solutions to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the brimonidine tartrate market.

Market Drivers

Several factors are driving the growth of the brimonidine tartrate market:

Rapid Urbanization and Pollution

Rapid urbanization has led to higher pollution levels, which significantly impact eye health. This increase in environmental pollutants drives the demand for effective eye care solutions, including brimonidine tartrate eye drops[1].

Surging Demand for Effective Ocular Solutions

There is a growing demand for long-lasting and effective artificial tears and ocular solutions. This demand is fueled by increasing awareness of eye healthcare and the early diagnosis of eye-related conditions globally[1].

Geriatric Population Growth

The rapidly growing geriatric population is another significant driver. Older adults are more prone to ocular conditions such as glaucoma and ocular hypertension, increasing the demand for brimonidine tartrate eye drops[1].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

Economic and Regulatory Hurdles

Economic and regulatory hurdles can significantly impact the market. These include high development costs, stringent regulatory approvals, and economic fluctuations that can affect manufacturing and distribution[1].

Market Challenges

International market fluctuations and regulatory hurdles can also challenge the growth and adoption of brimonidine tartrate eye drops. These challenges necessitate careful market analysis and strategic planning[1].

Market Opportunities

The market presents several opportunities for growth and innovation:

Developments in Drug Delivery Systems

Advancements in drug delivery systems offer opportunities for improved formulations of brimonidine tartrate. These innovations can enhance the efficacy and patient compliance of the treatment[1].

Increasing Prevalence of Ocular Conditions

The increasing prevalence of ocular conditions such as glaucoma and ocular hypertension necessitates enhanced availability of brimonidine tartrate solutions. This growing need drives market expansion and innovation[1].

Porter’s Five Forces Analysis

To understand the competitive landscape, a Porter’s Five Forces analysis is crucial:

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers to entry, including regulatory approvals and significant research and development costs[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low as the market is dominated by a few large pharmaceutical companies, allowing them to negotiate better terms[1].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and the level of patient awareness and education[1].

Threat of Substitute Products

The threat of substitute products is high due to the presence of other glaucoma treatments and ocular solutions in the market[1].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of multiple players and the need for continuous innovation to maintain market share[1].

Market Share Analysis

The market share analysis provides insights into the competitive nature of the sector:

Vendor Contributions

The analysis compares and analyzes vendor contributions, including overall revenue, customer base, and other vital metrics. This helps vendors understand their performance and the challenges they face in competing for market share[1].

Clinical Efficacy and Safety

Brimonidine tartrate has been extensively studied for its clinical efficacy and safety:

Mechanism of Action

Brimonidine tartrate works by reducing aqueous humor production and increasing uveoscleral outflow, thereby lowering IOP. This dual mechanism of action is supported by fluorophotometric studies in animals and humans[2].

Clinical Studies

Clinical studies have shown that brimonidine tartrate effectively lowers IOP in patients with open-angle glaucoma or ocular hypertension, with a comparable effect to other treatments like ALPHAGAN®[2][3].

Financial Trajectory

The financial trajectory of the brimonidine tartrate market is promising:

Market Size and Growth

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

Product Launches and Innovations

Recent product launches, such as the combination of brimonidine tartrate and timolol maleate, and innovations in drug delivery systems are driving market growth. These launches and innovations are critical for maintaining a competitive edge in the market[4].

Mergers, Acquisitions, and Partnerships

The increasing number of mergers, acquisitions, and partnerships in the biopharmaceutical sector is also driving growth. These collaborations facilitate the development and distribution of new and improved ophthalmic solutions[4].

Key Takeaways

• Growing Demand: The demand for brimonidine tartrate is driven by rapid urbanization, increasing awareness of eye healthcare, and the growing geriatric population.
• Market Opportunities: Developments in drug delivery systems and the increasing prevalence of ocular conditions present significant opportunities for growth.
• Competitive Landscape: The market is highly competitive, with a moderate threat of new entrants and high competitive rivalry among existing competitors.
• Financial Growth: The market is expected to grow significantly, with a projected CAGR of 7.3% until 2030.
• Clinical Efficacy: Brimonidine tartrate has been proven to be effective and safe in clinical studies, making it a valuable treatment option for glaucoma and ocular hypertension.

Frequently Asked Questions

What is the primary use of brimonidine tartrate eye drops?

Brimonidine tartrate eye drops are primarily used to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension[2].

How does brimonidine tartrate work?

Brimonidine tartrate works by reducing aqueous humor production and increasing uveoscleral outflow, thereby lowering IOP[2].

What are the common adverse events associated with brimonidine tartrate?

Common adverse events include dry mouth, fatigue/drowsiness, blurring, and conjunctival blanching[3].

What is the projected market size of the glaucoma eye drops market by 2030?

The global glaucoma eye drops market is expected to reach US$ 2,725.4 million by 2030, growing at a CAGR of 7.3%[4].

What are the key drivers of the brimonidine tartrate market?

Key drivers include rapid urbanization, surging demand for effective ocular solutions, and the growing geriatric population[1].

Cited Sources

1. 360iResearch: Brimonidine Tartrate Eye Drops Market Size & Share 2025-2030.
2. Drugs.com: Brimonidine: Package Insert / Prescribing Information.
3. PubMed: Development and use of brimonidine in treating acute and chronic elevated intraocular pressure.
4. Coherent Market Insights: Glaucoma Eye Drops Market Size, Trends And Forecast To 2030.
5. FDA: 204251Orig1s000 - accessdata.fda.gov.