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
Sengi	PHASE4
Prairie Eye Center	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.

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

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
South Korea	101738502
Slovenia	3045164
South Korea	20120028390	AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES

Supplementary Protection Certificates for SIMBRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	2014C/042	Belgium		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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221

Market Dynamics and Financial Trajectory for SIMBRINZA

Last updated: February 8, 2026

Overview
SIMBRINZA (brinzolamide 1%, brimonidine tartrate 0.2%) received FDA approval in 2013 for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Since then, its market performance has been shaped by competitive landscape, patent status, and evolving treatment guidelines.

Market Size and Revenue Performance

• Estimated global sales in 2022: approximately $60 million, with growth projections around 4% annually through 2027.
• North America accounts for nearly 70% of sales, driven by high awareness and established reimbursement pathways.
• Market penetration remains modest relative to leading monotherapies (e.g., prostaglandin analogs), constrained by its combination drug status and positioning as a second-line agent.

Competitive Positioning and Market Dynamics
-Product Competitors:

• Prostaglandins (e.g., latanoprost, travoprost): First-line treatments with higher efficacy and once-daily dosing.
• Other combination products: Cosopt (dorzolamide/timolol), Combigan (brimonidine/timolol).
• Newer agents: Rho kinase inhibitors (e.g., netarsudil) in some markets.

• Market Share:

  • SIMBRINZA holds an estimated 2-3% of the global glaucoma drug market, with potential for expansion via off-label use and physician preference shifts.

• Pricing and Reimbursement:

  • Average wholesale price (AWP) in the US: about $300 per bottle.
  • Reimbursement coverage varies, impacting patient access and prescribing patterns.
  • Price competition is intense due to multiple generic options for component drugs.

Patent and Regulatory Landscape

• Patent Status:

  • The original patent expired in 2023, opening the market to generics.
  • Patent challenges and patent term extensions may influence generic market entry timelines.

• Regulatory Approvals:

  • Approved in over 40 countries, with ongoing investigations into new indications or formulations.

Emerging Market and R&D Trajectory

• Pipeline Developments:

  • No current pipeline assets explicitly advancing SIMBRINZA, although the components are under active research for new formulations and delivery methods.
  • Potential future development involves fixed-dose combinations with prostaglandins or novel agents.

• Market Access Strategies:

  • Companies may pursue expanded labeling, including additional routes of administration or combination therapies.
  • Focus on reducing production costs and enhancing compliance to sustain competitiveness post-patent expiration.

Financial Outlook

• Flattish to slightly declining revenues anticipated post-2023 due to generic entry.
• Growth prospects linked to patent litigation outcomes, regulatory approvals of alternative therapies, and regional expansion strategies.

Key Factors Influencing Market Trajectory

• Patent expiration and generic competition will heavily impact revenues.
• Shifts in treatment guidelines favoring first-line prostaglandins will limit growth.
• Diversification into new formulations or delivery systems could create incremental revenue streams.

Summary
SIMBRINZA’s market has stabilized since its launch, with modest growth driven by incremental clinical benefits over monotherapy. Patent expiry and generic entries are likely to exert downward pressure unless new indications, formulations, or combination strategies are introduced. Strategic positioning involves balancing patent protections, optimizing pricing, and expanding market access, particularly in emerging regions.

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Key Takeaways

• SIMBRINZA’s global sales approximate $60 million as of 2022, with limited long-term growth prospects due to patent expiration.
• Competition from prostaglandins and generics constrains market share; pricing pressures are intensifying.
• The future financial trajectory depends on patent litigation, regional market expansion, and innovation in formulations.
• Major revenue decline expected post-2023 unless new indications or formulations are launched.
• Strategic advantages include established clinical use, but market share remains limited by competitive therapies.

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FAQs

1. When did SIMBRINZA receive FDA approval?
In 2013 for the reduction of intraocular pressure in adults with open-angle glaucoma or ocular hypertension.

2. What challenges will SIMBRINZA face following patent expiry?
Generic competition will exert price reductions, reducing revenue margins. Market share may decline unless the brand innovates or expands indications.

3. Are there alternative treatments that threaten SIMBRINZA’s market?
Yes. First-line prostaglandins typically outperform SIMBRINZA in efficacy, and newer therapies like Rho kinase inhibitors are entering some markets.

4. How significant is regional variation in SIMBRINZA’s market?
High in North America due to established healthcare infrastructure, lower in emerging markets where access and reimbursement barriers exist.

5. What opportunities exist for growth post-patent?
Development of fixed-dose combinations, new delivery methods, or expanding into additional indications could sustain or grow revenues.

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Sources:
[1] EvaluatePharma (2022), "Global glaucoma market data."
[2] IQVIA (2023), "Pharmaceutical sales data."
[3] U.S. FDA (2013), "SIMBRINZA approval announcement."