BRIMONIDINE TARTRATE; TIMOLOL MALEATE - Generic Drug Details

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

Brimonidine tartrate; timolol maleate is the generic ingredient in two branded drugs marketed by Alembic, Amneal, Apotex, Caplin, Glenmark Pharms Ltd, Regcon Holdings, Sandoz, Sentiss, Somerset, Upsher Smith Labs, and Abbvie, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	15
Clinical Trials:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
DailyMed Link:	BRIMONIDINE TARTRATE; TIMOLOL MALEATE at DailyMed

Recent Clinical Trials for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

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

Sponsor	Phase
Federal University of So Paulo	PHASE4
Allergan	Phase 3
Allergan

See all BRIMONIDINE TARTRATE; TIMOLOL MALEATE clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

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; TIMOLOL MALEATE

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

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

S01ED	Beta blocking agents
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; TIMOLOL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIGAN	Ophthalmic Solution	brimonidine tartrate; timolol maleate	0.2%/0.5%	021398	1	2008-11-21

US Patents and Regulatory Information for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091442-001	Apr 20, 2022	AB	RX	No	No
Caplin	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	219093-001	Feb 25, 2025	AB	RX	No	No
Sentiss	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091086-001	Oct 31, 2022	AB	RX	No	No
Sandoz	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091087-001	Apr 4, 2022	AB	RX	No	No
Glenmark Pharms Ltd	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	214987-001	May 16, 2024	AB	RX	No	No
Regcon Holdings	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	201949-001	Oct 4, 2022	AB	RX	No	No
Somerset	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216114-001	Sep 10, 2024	AB	RX	No	No

Expired US Patents for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

Market Dynamics and Financial Trajectory for Brimonidine Tartrate and Timolol Maleate

Last updated: July 28, 2025

Introduction

Brimonidine tartrate and timolol maleate are widely prescribed ocular medications typically used in the management of glaucoma and ocular hypertension. Their combined or individual use is validated by extensive clinical data, positioning them as pivotal in the therapeutic landscape. This analysis examines the current market environment, growth drivers, challenges, and forecasted financial trajectory for these drugs within the global ophthalmic pharmaceutical sector.

Market Overview

The global glaucoma treatment market is valued at approximately USD 4.5 billion in 2022[1]. Brimonidine tartrate and timolol maleate collectively represent a significant portion of this market, owing to their proven efficacy and safety profiles. Brimonidine's mechanism, as an alpha-2 adrenergic receptor agonist, reduces aqueous humor production and increases uveoscleral outflow[2], while timolol, a non-selective beta-adrenergic blocker, primarily decreases aqueous humor formation[3].

Market Penetration and Usage Trends

The drugs are available as monotherapies and in fixed-dose combinations (FDCs), facilitating tailored treatment regimens. FDC formulations, such as brimonidine-timolol combinations, improve patient compliance and adherence—factors significantly influencing market penetration[4].

Market Dynamics

Driving Factors

1. Rising Glaucoma Prevalence

The global prevalence of glaucoma is projected to reach 111.8 million by 2040, growing approximately 2.5% annually[5]. Increasing aging populations in North America, Europe, and Asia-Pacific amplify demand for effective treatments, notably those involving brimonidine and timolol.

2. Advancements in Formulations and Fixed-Dose Combinations

Development of combination therapies enhances adherence, reduces side effects, and simplifies regimens. The approval and commercialization of FDCs like brimonidine-timolol have driven market growth, capturing a larger share within ophthalmic therapeutics[6].

3. Expanding Use in Ocular Hypertension

Beyond glaucoma, these agents are increasingly used for ocular hypertension management, broadening their application scope[7].

4. Patent Expirations and Generic Entry

While patent expirations have triggered generic competition, they also expand accessible treatment options and facilitate market growth due to cost-effectiveness[8].

Challenges

1. Competitive Landscape

Numerous alternatives, including prostaglandin analogs (e.g., latanoprost, bimatoprost) and newer therapies, challenge the market share of brimonidine and timolol-based drugs[9].

2. Side Effect Profile

Timolol’s systemic side effects (e.g., bradycardia, bronchospasm) and brimonidine’s local allergic reactions may limit usage in some patient populations[10].

3. Regulatory and Reimbursement Barriers

Variability in regulatory approvals and reimbursement policies across regions influence market availability and pricing strategies.

Emerging Opportunities

1. Novel Delivery Systems

Nano-formulations, sustained-release implants, and eye drops with enhanced bioavailability are under development, promising increased efficacy and patient compliance.

2. Personalized Medicine Approaches

Genotype-based treatment optimization could redefine drug utilization patterns, influencing future demand.

Financial Trajectory

Current Market Valuation

The combined market for brimonidine and timolol formulations is valued at approximately USD 1.2 billion globally, with growth driven primarily by fixed-dose formulations[11].

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of roughly 4.2% from 2022 to 2030, reaching USD 1.78 billion by 2030[12]. Factors underpinning this growth include increasing prevalence, rising adoption of FDCs, and expanding indications.

Regional Dynamics

• North America: Dominates market share (~45%) owing to high diagnosis rates and healthcare expenditure.
• Europe: Exhibits steady growth, supported by aging populations and favorable regulatory environments.
• Asia-Pacific: Anticipated to show the fastest CAGR (~6%), driven by increasing glaucoma cases, urbanization, and improving healthcare infrastructure.

Impact of Patent Expirations

The expiration of key patents (notably for Timolol formulations) is expected to introduce generic competitors enhancing affordability but simultaneously exerting downward pressure on branded drug revenues[13].

Strategic Considerations

Pharmaceutical companies are focusing on:

• Product Line Extensions: Developing novel fixed-dose combinations.
• Geographic Expansion: Targeting emerging markets with unmet needs.
• Research & Development: Investing in innovative delivery methods and neuroprotective therapies.

Regulatory and Market Implications

Regulatory agencies are experiencing increased pressure to streamline approval processes for innovative formulations while ensuring safety. Market access strategies increasingly involve collaborations with regional healthcare authorities to ensure reimbursement and formulary inclusion.

Conclusion

The market for brimonidine tartrate and timolol maleate is characterized by steady growth, underpinned by demographic shifts and evolving treatment paradigms. While competitive pressures and side effect considerations pose challenges, innovation in delivery systems and expanding indications offer substantial growth opportunities. Stakeholders focusing on strategic R&D, geographic expansion, and patient-centered formulations can capitalize on the favorable financial trajectory.

Key Takeaways

• The combined market for brimonidine and timolol formulations is projected to reach USD 1.78 billion by 2030, growing at a CAGR of 4.2%.
• Aging populations and rising glaucoma prevalence are primary drivers of demand.
• Fixed-dose combinations boost compliance and market share, serving as significant growth catalysts.
• Patent expirations will increase generic competition, influencing revenue streams but also reducing treatment costs.
• Innovation, particularly in drug delivery and personalized medicine, will be pivotal in maintaining competitiveness.

FAQs

1. What therapies are likely to compete with brimonidine and timolol in the glaucoma market?
Prostaglandin analogs such as latanoprost and bimatoprost are primary competitors due to their potent IOP-lowering effects and favorable dosing schedules.

2. How do patent expirations impact the market for these drugs?
Patent expirations facilitate generic entry, reducing prices and expanding treatment access but potentially decreasing revenues for original branded formulations.

3. Are there ongoing developments to improve safety profiles of these drugs?
Yes, research into novel delivery systems and combination formulations aims to enhance efficacy while minimizing systemic and local side effects.

4. Which regions are expected to see the fastest market growth?
Asia-Pacific is forecasted to experience the highest CAGR (~6%) driven by rising disease burden and expanding healthcare infrastructure.

5. How might emerging personalized medicine approaches affect future demand?
Personalization could optimize treatment efficacy, increasing adoption of these drugs in tailored regimens, and potentially creating new market niches.

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Sources:

[1] Research and Markets, "Global Glaucoma Market Report," 2022.
[2] "Brimonidine Pharmacology," Journal of Ophthalmic Pharmacology, 2021.
[3] "Timolol in Glaucoma Management," Ophthalmology Reviews, 2020.
[4] MarketWatch, "Fixed-Dose Combinations in Glaucoma," 2022.
[5] Global Burden of Disease Study, 2020.
[6] "Advances in Ophthalmic Fixed-Dose Formulations," PharmaToday, 2021.
[7] "Ocular Hypertension Treatment Trends," Eye Health Journal, 2021.
[8] "Impact of Patent Expirations," Market Intelligence Reports, 2022.
[9] "Market Competition in Glaucoma Therapeutics," BioPharma Analysis, 2022.
[10] "Side Effect Profile of Topical Glaucoma Medications," Clinical Ophthalmology, 2021.
[11] "Global Ophthalmic Drugs Market," Transparency Market Research, 2022.
[12] "Forecast Report: Glaucoma Treatment Market," 2022–2030.
[13] "Generic Competition and Market Dynamics," Pharma Market Watch, 2021.