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Last Updated: March 18, 2026

brimonidine tartrate - Profile


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

Brimonidine tartrate is the generic ingredient in eleven branded drugs marketed by Padagis Israel, Galderma Labs Lp, Allergan, Abbvie, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Lupin Ltd, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Bausch And Lomb Inc, Alcon Labs Inc, Visus, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in forty NDAs. There are thirteen 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-three patent family members in thirty-two countries.

There is one tentative approval for this compound.

Summary for brimonidine tartrate
International Patents:163
US Patents:13
Tradenames:11
Applicants:24
NDAs:40
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for brimonidine tartrate
Generic filers with tentative approvals for BRIMONIDINE TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Get Started Free⤷  Get Started 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.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Israel BRIMONIDINE TARTRATE brimonidine tartrate GEL;TOPICAL 209158-001 Sep 23, 2021 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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

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 ⤷  Get Started Free ⤷  Get Started Free
Allergan ALPHAGAN brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 020613-001 Sep 6, 1996 ⤷  Get Started Free ⤷  Get Started Free
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for brimonidine tartrate

Country Patent Number Title Estimated Expiration
Spain 2550473 ⤷  Get Started Free
Japan 5747391 ⤷  Get Started Free
China 101426502 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for brimonidine tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 92462 Luxembourg ⤷  Get Started 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 CR 2014 00031 Denmark ⤷  Get Started Free PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
1631293 C 2014 030 Romania ⤷  Get Started 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Brimonidine Tartrate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Brimonidine tartrate, a selective alpha-2 adrenergic receptor agonist, is primarily marketed for ocular conditions such as glaucoma and ocular hypertension under brands like Alphagan P. The global market for brimonidine is projected to grow driven by increasing glaucoma prevalence, expanding indications, and rising demand for targeted ocular therapies. Investment considerations hinge on patent landscapes, regulatory pathways, and competitive positioning within the ophthalmic drug sector. This report provides a comprehensive market analysis, financial forecasts, and strategic insights into the drug's investment potential.


What is the Current Market Landscape for Brimonidine Tartrate?

Therapeutic Applications and Demographic Drivers

Indication Market Size (USD) Key Drivers Notes
Glaucoma/Ocular Hypertension $3.0 billion (2022) Aging populations, increased screening, awareness Predominant use in adults over 40
Rosacea (Alternative App.) Emerging but limited Growing dermatological research Off-label use, niche segment

Market Players and Patent Status

Company Product Name Patent Expiry Market Strategy
Allergan (AbbVie) Alphagan P 2022 (patent expiry) Focused on formulations and new delivery systems
Others Generic Brands Varies Market entry post-patent expiry; price competition intensifies

Patent and Regulatory Landscape

  • Patent Expiry: The key patent for Alphagan P expired in 2022, opening the market to generic entrants.
  • Regulatory Approvals:
    • US FDA approval for multiple formulations, including fixed-dose combinations.
    • EMA approvals for European markets.
    • Ongoing trials exploring new formulations, including sustained-release and combination therapies.

Market Dynamics Influencing Investment Decisions

Growth Drivers

  • Rising Prevalence of Glaucoma: Worldwide, approximately 76 million individuals affected (2020 estimates), projected to reach 111 million by 2040 (source: WHO [1]).
  • Innovative Delivery Systems: Sustained-release implants, combination therapies enhance adherence and efficacy.
  • Expansion into Adjacent Indications: Emerging evidence supports use in rosacea and other neurovascular conditions.

Challenges and Risks

Risk Factors Impact Mitigation Strategies
Patent expiration (post-2022) Increased generic competition reduces margins Investment in formulation innovations
Regulatory hurdles for new indications Slower approval pathways Conduct comprehensive clinical trials
Market saturation Limited growth potential in mature markets Geographic expansion, biosimilar developments
Supply chain disruptions Production delays, cost increases Diversify manufacturing and procurement channels

Competitive Landscape

Competitors Market Share (%) Key Differentiators Strategies
Allergan (AbbVie) ~60% (pre-patent expiry) Well-established, strong branding R&D investment, patent protection
Generic Manufacturers Remaining 40% Cost efficiency, broader access Price competition, new formulations

Financial Trajectory Projections

Revenue Forecast (2023-2030)

Year Estimated Global Market Size (USD) Brimonidine Market Share Estimated Revenue (USD) Notes
2023 $3.4 billion 48% $1.63 billion Post-patent expiry, increased generics
2024 $3.7 billion 44% $1.63 billion Price competition intensifies
2025 $4.0 billion 41% $1.64 billion Innovation-driven market growth
2026 $4.2 billion 39% $1.64 billion Rising adoption for combination therapies
2027 $4.5 billion 36% $1.62 billion Competitive pressure, new formulations
2028 $4.8 billion 34% $1.63 billion Geographic expansion impacts
2029 $5.1 billion 32% $1.63 billion Emerging markets growth
2030 $5.4 billion 30% $1.62 billion Market stabilization

Profitability and Investment Returns

  • Gross Margin: Estimated at 60–70% pre-patent expiry, declining to 55–65% due to generic entry.
  • R&D Investment: Continued R&D focus on novel delivery mechanisms and new indications is crucial.
  • Licensing and Partnerships: Potential revenue through licensing innovative formulations and combination drugs.

Comparison with Other Ophthalmic Drugs

Drug Market Size (USD) Main Indications Patent Status Key Differentiator
Timolol ~$1.2 billion Glaucoma, ocular hypertension Expired Fixed-dose combinations
Travoprost ~$950 million Elevated intraocular pressure Active patents Once-daily dosing
Brimonidine $3.0 billion Glaucoma, ocular hypertension Post-patent Synergistic with other agents

Brimonidine's position as a monotherapy and component in combination therapies makes it a focal point for sustained market relevance.


Strategic Considerations for Investors

Opportunities

  • Post-Patent Entry: Exploiting generic manufacturing and marketing to gain market share.
  • Innovative Formulations: Investing in sustained-release systems or combination therapies to differentiate portfolios.
  • Emerging Markets: Tapping into markets with increasing glaucoma prevalence and less saturated ophthalmic sectors.

Risks

  • High Competition: Price erosion following patent expiry.
  • Regulatory Delays: For new formulations or indications.
  • Market Penetration: Challenges establishing market share against entrenched brands.

Concluding Insights

Aspect Key Points
Market Potential Significant, driven by demographic trends and innovation
Patent and Competition Patent expiry in 2022 opens volume opportunities, margins may decline unless differentiated
Innovation and Differentiation Essential for maintaining profitability amid generic competition
Regulatory Environment Supportive but requires strategic planning for new indications and formulations
Financial Outlook Moderate growth with stable revenues; margins under pressure post-patent expiry

Key Takeaways

  • The expiration of key patents in 2022 necessitates strategic focus on innovation and market expansion.
  • The global glaucoma market offers sustained growth, especially through combination therapies and emerging markets.
  • Investment in novel delivery systems presents opportunities for market differentiation and higher margins.
  • Competitive intensity underscores the importance of patent protection, regulatory success, and clinical differentiation.
  • Financial forecasts post-2022 project stable revenues with potential growth if innovative formulations and new indications are successfully commercialized.

FAQs

1. What is the primary therapeutic use of brimonidine tartrate?

Primarily used to lower intraocular pressure in glaucoma and ocular hypertension.

2. How does patent expiry impact the market for brimonidine?

Patent expiry in 2022 led to increased generic competition, reducing prices and margins but expanding volume sales.

3. What are the key opportunities for investment post-patent expiry?

Developing sustained-release formulations, combination therapies, and expanding into emerging markets.

4. What challenges could affect the financial trajectory of brimonidine?

Market saturation, pricing pressures due to generics, regulatory hurdles for new formulations, and commoditization.

5. How does brimonidine compare with other ophthalmic drugs?

It has a broader market size than many competitors due to its widespread use, though competition is intensifying with generics.


References

[1] World Health Organization (WHO). "Global data on glaucoma," 2020.

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