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Last Updated: April 14, 2025

BRIMONIDINE TARTRATE - Generic Drug Details


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What are the generic sources for brimonidine tartrate and what is the scope of freedom to operate?

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, Amneal, Caplin, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty-eight NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has one hundred and sixty-four 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.

Drug Prices for BRIMONIDINE TARTRATE

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Drug Sales Revenue Trends for BRIMONIDINE TARTRATE

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Recent Clinical Trials for BRIMONIDINE TARTRATE

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

SponsorPhase
Tulane UniversityPhase 4
Visus TherapeuticsPhase 3
Optall VisionPhase 1

See all BRIMONIDINE TARTRATE clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free0.2%; 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
Medical Subject Heading (MeSH) Categories for BRIMONIDINE TARTRATE
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QOLIANA Ophthalmic Solution brimonidine tartrate 0.15% 021764 1 2023-10-24
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 AT RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apotex BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078480-001 Dec 21, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz BRIMONIDINE TARTRATE AND TIMOLOL MALEATE brimonidine tartrate; timolol maleate SOLUTION/DROPS;OPHTHALMIC 091087-001 Apr 4, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 203172-001 Mar 4, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes 9,861,631 ⤷  Try for Free ⤷  Try for Free
Dr Reddys Labs Sa BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 216361-001 Feb 16, 2024 OTC No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

Expired US Patents for BRIMONIDINE TARTRATE

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 6,194,415*PED ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 6,627,210*PED ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021770-001 Aug 19, 2005 6,641,834*PED ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 6,627,210*PED ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 5,736,165*PED ⤷  Try for Free
Abbvie ALPHAGAN P brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 021262-001 Mar 16, 2001 6,248,741*PED ⤷  Try for Free
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 8,859,551 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 7 of 7 entries

International Patents for BRIMONIDINE TARTRATE

CountryPatent NumberTitleEstimated Expiration
Australia 2005247467 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders ⤷  Try for Free
Canada 2732521 COMPOSITIONS DE VASOCONSTRICTION, ET PROCEDES D'UTILISATION (VASOCONSTRICTION COMPOSITIONS AND METHODS OF USE) ⤷  Try for Free
Mexico 2016002485 COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE CONDICIONES NASALES. (COMPOSITIONS AND METHODS FOR THE TREATMENT OF NASAL CONDITIONS.) ⤷  Try for Free
Mexico PA05014107 COMPUESTOS, FORMULACIONES Y METODOS PARA TRATAR O PREVENIR EL ACNE ROSACEA. (COMPOUNDS, FORMULATIONS, AND METHODS FOR TREATING OR PREVENTING ROSACEA.) ⤷  Try for Free
Poland 1761266 ⤷  Try for Free
South Korea 20120128610 ⤷  Try for Free
South Korea 101707704 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for BRIMONIDINE TARTRATE

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1631293 122014000080 Germany ⤷  Try for Free PRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 14C0056 France ⤷  Try for Free PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 191 5019-2014 Slovakia ⤷  Try for Free PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
1631293 2014C/042 Belgium ⤷  Try for Free 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 ⤷  Try for Free 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 C 2014 030 Romania ⤷  Try for Free 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 C300683 Netherlands ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 7 of 7 entries

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.

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