SIMBRINZA Drug Patent Profile

Which patents cover Simbrinza, and what generic alternatives are available?

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 October 30, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMBRINZA

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 9,044,484.

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

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
World Intellectual Property Organization (WIPO)	2004073708
Argentina	077126
Argentina	122017
Australia	2010262898

Supplementary Protection Certificates for SIMBRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	92462	Luxembourg		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	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	201440029	Slovenia		PRODUCT NAME: BRIMONIDINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; NATIONAL AUTHORISATION NUMBER: EU/1/13/904/001-003; DATE OF NATIONAL AUTHORISATION: 20140221; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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

SIMBRINZA (brinzolamide 1% / brimonidine 0.2%) investment scenario and patent fundamentals (US focus)

Last updated: July 9, 2026

Executive summary

• SIMBRINZA is an ophthalmic fixed-dose combination for lowering intraocular pressure in glaucoma and ocular hypertension. The product is marketed as a branded combination product (brinzolamide + brimonidine).
• A complete, investment-grade patent and exclusivity fundamentals map for SIMBRINZA cannot be produced from the information provided in this request alone. Without verified Orange Book listings, patent numbers, FDA regulatory milestones, and known litigation/settlement facts, any attempt to produce expiration timelines or licensing risk would be incomplete.

What patents protect SIMBRINZA (brinzolamide brimonidine fixed-dose combination) in the US?

A complete protection map requires the specific SIMBRINZA NDA and its corresponding US FDA Orange Book patent listings (US patents tied to the approved drug product, plus any method-of-use and formulation patents). The request does not include the NDA number, Orange Book record, or patent identifiers, so the patent estate cannot be enumerated accurately.

How many patents cover SIMBRINZA drug product vs methods of use?

A count requires the Orange Book “drug product” and “method of use” listing split by patent number, assignee, and expiration date. No such listing data is present in the request.

Which companies hold the SIMBRINZA patent estate?

A reliable “who holds what” inventory also requires Orange Book assignees or patent prosecution/assignment records. The request provides no assignees or patent numbers.

When does SIMBRINZA lose exclusivity? What is the patent expiration timeline?

Exclusivity and patent-loss timing in the US is driven by:

• Orange Book patent expiration dates tied to the NDA
• Any pediatric exclusivity or other statutory exclusivities
• Switching or expiration of listed patents (including second medical use, formulation, and manufacturing-related listings)

The request does not provide:

• Orange Book expiration dates
• Exclusivity end dates
• NDA approval or supplemental approval dates

As a result, no defensible timeline can be produced.

What is the Orange Book status of SIMBRINZA (NDA exclusivity, listed patents, and expiration dates)?

Orange Book status is a structured dataset: NDA/BLA number, dosage form, strength, patent list with statutory basis, expiration dates, and exclusivity periods. None of these identifiers are included in the request, so the Orange Book status cannot be summarized without risking factual errors.

What generic entry risks exist for SIMBRINZA (Paragraph IV ANDA filing scenarios)?

A Paragraph IV ANDA risk analysis requires:

• Whether an ANDA has been filed
• Whether it is tied to SIMBRINZA’s NDA and which Orange Book patents it challenges
• Whether litigation has been triggered and what patents were asserted

The request includes no ANDA/Paragraph IV status, no notice dates, and no litigation dockets.

How strong is the patent estate for brinzolamide/brimonidine combination products?

Patent strength depends on:

• Number and scope of listed patents (product, formulation, method of use)
• Claim breadth relative to typical generic design-around strategies
• Whether patents have been litigated or survived invalidity challenges
• Whether the combination has multiple independently blocking patents

No patent list or claim scope inputs are provided.

What formulations are protected by SIMBRINZA patents (fixed combination composition, preservatives, pH, and delivery system claims)?

Formulation patent risk needs the actual patent claims covering:

• Fixed-dose composition parameters (e.g., concentrations, pH, buffer system)
• Preservatives and viscosity agents
• Osmolality/tonicity targets
• Manufacturing controls

Without the SIMBRINZA formulation patent numbers and claim text, no accurate protection assessment can be generated.

What patent litigation affects SIMBRINZA (settlements, consent decrees, or court rulings)?

A litigation risk view requires:

• Court docket identifiers
• Asserted patents and outcomes (dismissals, claim constructions, infringement findings)
• Settlement or consent judgment details (entry dates, license scope)
• Federal Circuit/appeal outcomes

No litigation facts are provided in the request.

What settlements and licensing deals constrain generic launch for SIMBRINZA?

A settlements and licensing analysis requires the specific agreement terms:

• “Design-around” allowed or prohibited
• Launch date caps
• Scope limitations by dosage form or strength
• Royalty structures
• Dismissal of specific patents

No settlement or license data is supplied.

How does SIMBRINZA compare with generic brinzolamide plus brimonidine or alternative glaucoma combinations (patent and commercial risk)?

A comparison requires either:

• Named comparator products and their patent estates
• Or at minimum, the active ingredient-level landscape (which brand combinations are co-marketed, what patents protect them, and where they sit on expiration)

The request does not include comparators or their patent/Orange Book data.

Regulatory fundamentals: What is the FDA status of SIMBRINZA (approval pathway, label scope, and exclusivity implications)?

Regulatory risk and timing are tied to:

• NDA approval history and supplements
• Label expansions that may bring new exclusivities
• Pediatric exclusivity, orphan status (if any), and other statutory exclusivity triggers
• Label indications (glaucoma and ocular hypertension categories) that can define method-of-use patent risk

No FDA record details (NDA number, approval date, supplement chronology) are included.

Manufacturing and IP barriers: Can a generic avoid SIMBRINZA patents by changing formulation or process?

This requires claim-level analysis of patents that cover:

• The composition itself (composition claims)
• The method of making (process claims)
• The method of treating (medical use claims tied to clinical dosing)
• Manufacturing controls that are tied to product performance

No patent claims or manufacturing process data is provided.

Commercial scenario fundamentals: what revenue exposure and demand drivers matter for SIMBRINZA investors?

An investment case also needs commercial facts:

• Peak annual sales and current run-rate
• Share vs competing agents (fixed combinations and monotherapies)
• Pricing dynamics and payer access
• Prescriber share and persistence
• Geographic revenue mix
• Customer concentration and channel inventory risk

The request provides no sales, share, payer, or geography inputs, so no fundamentals-based financial scenario can be calculated.

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Key Takeaways

• An investment-grade patent and exclusivity fundamentals analysis for SIMBRINZA cannot be completed from the information contained in the request.
• Building an actionable scenario requires verified Orange Book listings (NDA number, listed patents with expirations), FDA exclusivity dates, and any known litigation or settlement data tied to Paragraph IV ANDAs.
• Without those inputs, any specific expiration timeline, generic entry risk ranking, or patent-strength conclusion would be non-actionable.

FAQs

1. What NDA number is SIMBRINZA listed under in the FDA Orange Book?
2. Which SIMBRINZA patents are listed as “drug product” versus “method of use” in the Orange Book?
3. Have any generic ANDAs for SIMBRINZA been filed with Paragraph IV certifications?
4. What is SIMBRINZA’s exclusivity end date in the US and does it include pediatric exclusivity?
5. What dosage forms or strengths (if multiple) have separate patent listings for SIMBRINZA?

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References

None.