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
Uruguay	32709	COMPOSICIONES FARMACÉUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS BORATO-POLIOL
China	102802604	Aqueous pharmaceutical compositions containing borate-polyol complexes
San Marino	T201600249	COMPOSIZIONI FARMACEUTICHE ACQUOSE CONTENENTI COMPLESSI BORATO- POLIOLO
China	104707145	Aqueous pharmaceutical compositions containing borate-polyol complexes

Supplementary Protection Certificates for SIMBRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014/041	Ireland		PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/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	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

Market Dynamics and Financial Trajectory for SIMBRINZA

Last updated: July 27, 2025

Introduction

SIMBRINZA (brinzolamide 1% and brimonidine tartrate 0.2%) is an innovative combination drug approved primarily for the management of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Since its approval by the FDA in 2016, SIMBRINZA has carved a niche within the competitive landscape of glaucoma therapies. This article offers a detailed analysis of market drivers, competitive forces, revenue forecasts, and strategic considerations shaping its financial trajectory.

Market Overview and Epidemiological Drivers

Globally, glaucoma affects over 76 million individuals, with projections suggesting an increase to 111 million by 2040 [1]. The dominant clinical goal is to reduce IOP, preventing optic nerve damage. The global glaucoma drugs market was valued at approximately USD 5.5 billion in 2021 and is expected to grow at a CAGR of around 4.7% through 2028 [2].

The increasing prevalence, aging populations, and heightened awareness among healthcare providers underpin sustained demand. Moreover, the shift towards combination drugs—like SIMBRINZA—addresses adherence challenges by reducing the complexity of medication regimens.

Product Profile and Competitive Positioning

Pharmacological Profile:
SIMBRINZA combines brinzolamide (a carbonic anhydrase inhibitor) with brimonidine (an alpha-2 adrenergic agonist), delivering dual IOP-lowering action within a single topical formulation. Its fixed-dose design enhances patient convenience and adherence.

Competitive Landscape:
SIMBRINZA’s key competitors include monotherapies and other fixed-dose combinations like Cosopt (dorzolamide/timolol), Xalacom (latanoprost/timolol), and various prostaglandin analogs. While prostaglandins like latanoprost dominate the market due to efficacy and tolerability, combination drugs are increasingly preferred due to better adherence and reduced dosing frequency.

Unique Selling Points (USPs):

• Dual-action mechanism
• Preservative-free formulation (for some variants)
• Once or twice daily dosing
• Favorable safety profile

These USPs influence market adoption, particularly among patients intolerant to monotherapies or requiring multi-mechanism control.

Market Dynamics Influencing SIMBRINZA’s Trajectory

1. Growing Demand for Fixed-Dose Combinations:
Clinicians increasingly favor fixed-dose combinations to simplify treatment regimens, especially in chronic conditions like glaucoma. This trend bolsters SIMBRINZA’s sales potential [3].

2. Patent and Exclusivity Landscape:
Initially protected until around 2026, patent protections influence launch strategies of generics or biosimilars. The expiration of patents typically leads to price declines and increased competition, impacting revenue projections.

3. Regulatory Environment:
Global regulatory agencies are favoring innovative combinatorial products that demonstrate improved safety and compliance. Furthermore, ongoing advancements in drug delivery and formulations could enhance future versions of SIMBRINZA or similar drugs.

4. Reimbursement and Access:
Insurance coverage, formulary placements, and reimbursement policies significantly influence product uptake, especially in developed healthcare markets like the US and Europe.

5. Prescriber Acceptance and Patient Preferences:
Physician familiarity with the drug, proven efficacy, and tolerability drive utilization. As awareness of SIMBRINZA’s benefits grows, market penetration is expected to improve.

Financial Trajectory and Revenue Projections

Historical Sales Performance:
Sales since 2016 have been modest relative to dominant therapies, partly due to late market entry and competition. In 2021, top-line revenue for SIMBRINZA was approximately USD 250 million globally [4].

Forecasted Growth Dynamics:
Analysts project that the revenue for SIMBRINZA could grow at a CAGR of 6-8% over the next five years, driven by increased adoption, expanded indications (e.g., in secondary glaucoma), and geographic expansion into emerging markets.

Impact of Patent Expiry and Generics:
Post-patent expiration, generic versions could erode margins and volume, but this may be offset by higher overall volume as price competition intensifies. Preserving market share may hinge on continued innovation and formulary positioning.

Strategic Initiatives and Market Expansion:
Pharmaceutical companies are investing in awareness campaigns, exploring new delivery systems, and pursuing label extensions to bolster revenue streams.

Pricing Strategies:
Premium positioning in markets with less price sensitivity could sustain margins, while aggressive pricing in emerging markets may foster higher volume growth.

Emerging Trends and Future Outlooks

1. Biosimilars and Generics:
The advent of biosimilars or generics post-patent expiry will fundamentally alter the competitive landscape, leading to potential price erosion but also expanding access.

2. Combination with Novel Agents:
Research into combining SIMBRINZA with other therapies could expand its utility, creating new revenue avenues.

3. Digital Health Integration:
Incorporating dose tracking and adherence monitoring could enhance patient engagement, driving consistent use and revenue.

4. Market Penetration Strategies:
Partnering with regional distributors and customizing formulary strategies are essential for penetrating emerging markets with high glaucoma prevalence.

Regulatory and Commercial Challenges

• Pricing Pressures: Cost containment policies in governmental healthcare programs can limit profitability.
• Adherence Issues: Despite formulation advantages, patient adherence remains a hurdle, especially in regions with low health literacy.
• Market Saturation: Dominance of prostaglandin analogs may hinder growth unless SIMBRINZA emphasizes its unique benefits.

Conclusion

SIMBRINZA occupies a strategic position within the glaucoma therapeutics space, benefiting from escalating global demand, clinician preference for fixed-dose combinations, and its dual-mechanism profile. Market expansion will depend on patent lifecycle management, competitive pricing, clinical positioning, and innovative marketing. The drug’s financial trajectory appears positive in the near term, with sustained growth prospects contingent upon overcoming generic competition and capturing emerging market opportunities.

Key Takeaways

• The global glaucoma market’s growth favors SIMBRINZA’s continued prescription, especially as combination therapies gain favor.
• Patent expiration post-2026 presents both challenges and opportunities: potential revenue decline versus the chance to capture generic market share.
• Strategic focus on expanding indications, improving formulations, and enhancing patient adherence will be crucial.
• Pricing, reimbursement, and formulary positioning in different markets will directly influence sales performance.
• Competitive dynamics necessitate continuous innovation and strategic partnerships to sustain market share.

FAQs

1. What is the primary clinical advantage of SIMBRINZA?
Its fixed-dose combination provides dual mechanisms of IOP reduction, improving adherence and convenience for patients managing glaucoma.

2. When is patent expiry expected, and how will it influence the market?
Patent protection is anticipated to expire around 2026, likely leading to increased generic competition and potential price erosion.

3. Which markets are poised for the highest growth for SIMBRINZA?
Emerging markets in Asia, Latin America, and parts of Africa are projected to see the fastest growth due to rising glaucoma prevalence and expanding healthcare access.

4. How does SIMBRINZA compare to prostaglandin-based therapies?
While prostaglandins are often first-line due to efficacy and tolerability, SIMBRINZA is favored in cases requiring additional IOP lowering or when prostaglandin therapy is contraindicated or ineffective.

5. What strategies can pharma companies adopt to enhance SIMBRINZA’s market share?
Strategies include expanding indications, optimizing formulary positioning, investing in education campaigns, and developing new delivery systems to improve patient adherence.

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Sources:
[1] Tham Y-C, et al. Global Prevalence of Glaucoma and Projections. Ophthalmology. 2014;121(4):718-728.
[2] Grand View Research. Glaucoma Drugs Market Size & Trends. 2022.
[3] Dureja H, et al. Fixed-dose combination therapies: innovations in ophthalmology. Therapeutic Advances in Chronic Disease. 2021.
[4] Company Annual Reports and Market Data (2021-2022).