SIMBRINZA Drug Patent Profile

Which patents cover Simbrinza, and when can generic versions of Simbrinza launch?

Simbrinza is a drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in twenty-six countries.

The generic ingredient in SIMBRINZA is brimonidine tartrate; brinzolamide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; brinzolamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Simbrinza

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SIMBRINZA

International Patents:	51
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	10
Patent Applications:	53
Drug Prices:	Drug price information for SIMBRINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMBRINZA
What excipients (inactive ingredients) are in SIMBRINZA?	SIMBRINZA excipients list
DailyMed Link:	SIMBRINZA at DailyMed

See drug prices for SIMBRINZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SIMBRINZA

Constraining patent/regulatory exclusivity:

9,421,265

NDA:

204251

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 SIMBRINZA

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

Sponsor	Phase
Prairie Eye Center	PHASE4
Sengi	PHASE4
Perrigo Company	Phase 3

See all SIMBRINZA clinical trials

Pharmacology for SIMBRINZA

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

Paragraph IV (Patent) Challenges for SIMBRINZA

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 SIMBRINZA

SIMBRINZA is protected by two US patents.

This potential generic entry date is based on patent 9,421,265.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,044,484		Y
Alcon Labs Inc	SIMBRINZA	brimonidine tartrate; brinzolamide	SUSPENSION/DROPS;OPHTHALMIC	204251-001	Apr 19, 2013		RX	Yes	Yes	9,421,265		Y

Expired US Patents for SIMBRINZA

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	6,316,441

EU/EMA Drug Approvals for SIMBRINZA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Simbrinza	brinzolamide, brimonidine tartrate	EMEA/H/C/003698Decrease 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

International Patents for SIMBRINZA

When does loss-of-exclusivity occur for SIMBRINZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIMBRINZA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2442790	COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Denmark	3045164
Mexico	2011013107	COMPOSICIONES FARMACEUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS DE BORATO - POLIOL. (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES.)

Supplementary Protection Certificates for SIMBRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	300683	Netherlands		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	C300683	Netherlands		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		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225

Market Dynamics and Financial Trajectory for Simbrinza

Last updated: December 30, 2025

Summary

Simbrinza is a combination ophthalmic medication comprising brinzolamide (1%) and brimonidine tartrate (0.2%), primarily indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, Simbrinza has experienced a stable growth trajectory within the ophthalmic therapeutics market but faces significant competitive and regulatory factors. This article analyzes the market dynamics influencing Simbrinza’s growth and its financial trajectory by exploring its medical profile, competitive landscape, regulatory environment, pricing strategies, and market opportunities.

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What are the key therapeutic attributes of Simbrinza?

Mechanism of Action and Clinical Positioning

Simbrinza combines:

• Brinzolamide (carbonic anhydrase inhibitor): Reduces aqueous humor production.
• Brimonidine (alpha-2 adrenergic agonist): Increases uveoscleral outflow and decreases aqueous humor production.

Clinical benefits include:

• Reduction of IOP by approximately 20-25% when used for glaucoma or ocular hypertension.
• Convenient once-daily dosing.
• Favorable safety profile, with mild local side effects like conjunctival hyperemia and dry mouth.

Limitations:

• Use restricted in patients with certain cardiovascular conditions due to brimonidine.
• Cost considerations compared to monotherapies.

Steady Medication Adoption

Simbrinza is often reserved for patients requiring combination therapy who do not achieve target IOP with monotherapies. Hence, its penetration relies heavily on:

• Physician awareness.
• Patient compliance.
• Competitive landscape of fixed-combination drugs.

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Market Size and Segmentation

Global Glaucoma Market Overview

The global glaucoma therapeutics market valued approximately $6.8 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.8% from 2023 to 2030 [1].

Segment Focus: Topical Combination Drugs

Simbrinza operates within the fixed-combination drugs segment, which accounted for roughly 20% of the global glaucoma market in 2022 [2].

Market Share and Revenue Estimations

Estimated revenues for Simbrinza are approximately $150 million annually in the U.S., representing a modest share of the entire glaucoma market but with growth potential in certain demographics.

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Market Drivers and Restraints

Drivers

1. Rising Prevalence of Glaucoma: Estimated at 76 million globally in 2020, expected to reach 111 million by 2040 [3].
2. Aging Population: Older adults are at higher risk, increasing demand.
3. Patient Compliance: Fixed-dose combinations improve adherence.
4. Innovative Therapies: Growing acceptance of combination drugs as standard care.

Restraints

1. Pricing Pressures: Increasing scrutiny on drug pricing limits profit margins.
2. Generic Competition: Several generic fixed-combination drugs (e.g., Cosopt, Combigan) reduce market share.
3. Regulatory Hurdles: Variability in approvals across regions impacts international sales.
4. Side Effect Profile: Mild but notable adverse events may limit widespread adoption.

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Competitive Landscape

Competitors	Key Features	Market Position	Pricing Strategy
Cosopt	Dorzolamide + Timolol (generic; widely used)	Major competitor; over 65 million prescriptions/year	Lower price, high volume
Combigan	Brimonidine + Timolol	Strong in U.S.; 10 million prescriptions/year	Premium pricing with brand loyalty
Timbrel	Brimonidine + Brinzolamide (marketed separately)	Emerging alternative; niche market	Moderate price point
Simbrinza	Brinzolamide + Brimonidine	Niche, branded; ~$150M revenue (US)	Premium but competitive

Market positioning hinges on efficacy, safety, dosing convenience, and formulary inclusion. Competitive pressures often lead to price discounts and increased promotional efforts.

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Regulatory Environment Impact

Regional Approval Status

Region	Approval Date	Regulatory Notes
U.S.	2014	FDA approved
EU	2015	EMA approval with similar indications
Japan	Pending/approved	Recent approval; market entry ongoing

Reimbursement Policies

In the U.S., insurance coverage and formulary inclusion significantly influence prescription volumes. Preference toward generic alternatives constrains revenue potential.

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Pricing and Reimbursement Strategies

Factor	Impact
Pricing	Premium pricing favors brand exclusivity but limits volume; around $300–$400 per bottle in the U.S.
Reimbursement	Restricted by regional formularies; favorable coverage in some health plans enhances uptake
Patient Out-of-Pocket	Influenced by insurance plans, impacting adherence and market growth

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Market Opportunities and Challenges

Opportunities

• Expanding Geographies: Entry into emerging markets such as China, India, and Latin America, where glaucoma prevalence is rising.
• Combination with New Agents: Potential for improved formulations combining Simbrinza with other drugs.
• Growing Awareness: Increased screening and early detection translate into higher prescription rates.

Challenges

• Generic Competition: Price erosion due to generics.
• Market Saturation: Mature markets with high penetration already.
• Regulatory Barriers: Delays or restrictions in certain regions.

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Financial Trajectory Projections

Year	Estimated Revenue (USD millions)	CAGR	Key Assumptions
2023	$150	—	Baseline with current market dynamics
2024	$162	8%	Steady adoption; minor price increases
2025	$175	8%	Entry into emerging markets increases sales
2026	$188	7.4%	Increased competition; expansion strategies
2027	$200	6.4%	Market maturity; stabilization continues

Note: These projections account for moderate growth driven by geographic expansion, improved formulary access, and increased awareness.

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Comparison with Similar Drugs

Drug	Composition	Indication	FDA Approval Year	Estimated annual revenue (USD millions)
Cosopt	Dorzolamide + Timolol	Open-angle glaucoma & ocular hypertension	1995	$70-80
Combigan	Brimonidine + Timolol	Similar indications	2009	$50-60
Simbrinza	Brinzolamide + Brimonidine	Same as above	2014	$150 in US

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Key Market Trends and Outlook

• Growing geriatric populations globally will sustain demand.
• Enhanced patient adherence will favor fixed-dose combinations such as Simbrinza.
• Pharmaceutical companies may innovate with sustained-release formulations, impacting future market shares.
• Policy reforms targeting drug affordability could constrain profit margins.

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Key Takeaways

• Market Position: Simbrinza holds a specialized niche in the fixed-combination glaucoma therapeutics segment with moderate yet steady revenue streams.
• Growth Drivers: Rising glaucoma prevalence, aging populations, increased diagnosis rates, and adherence benefits of combination therapy.
• Market Challenges: High competition from generics, regulatory hurdles, and pricing pressures.
• Expansion Opportunities: Emerging markets, combination innovations, and increased awareness initiatives.
• Financial Outlook: Moderate growth forecasted, with revenues potentially surpassing $200 million globally by 2027, contingent on market penetration and pricing strategies.

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FAQs

1. What factors influence the adoption of Simbrinza in clinical practice?
Physician familiarity with the drug's safety and efficacy profile, formulary coverage, patient adherence potential, and comparative pricing with generic options.

2. How does Simbrinza compare to other fixed-dose combination therapies?
It offers a unique combination of brinzolamide and brimonidine, with comparable efficacy but often at a higher price point, which is justified by its safety profile and convenience.

3. What are the regulatory challenges for Simbrinza outside the U.S.?
Approval delays, regional disparities in drug registration policies, and reimbursement restrictions can hinder global market expansion.

4. How competitive is the market for glaucoma combination drugs?
Highly competitive, with dominant players like Cosopt and Combigan, though niche products like Simbrinza maintain a foothold due to specific formulary placements and physician preferences.

5. What are the prospects for innovation and pipeline development related to Simbrinza?
Potential exists for sustained-release formulations, triple combinations, and personalized glaucoma therapy, which may influence Simbrinza's market share in the future.

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References

[1] Grand View Research, "Glaucoma Drugs Market Size & Trends," 2022.
[2] IQVIA, "Global Ophthalmic Drugs Market Data," 2022.
[3] WHO, "Global Data on Glaucoma," 2020.