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Last Updated: September 25, 2022

SIMBRINZA Drug Patent Profile


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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 forty-nine 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. Two suppliers are 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for SIMBRINZA
International Patents:49
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 9
Patent Applications: 25
Drug Prices: Drug price information for SIMBRINZA
What excipients (inactive ingredients) are in SIMBRINZA?SIMBRINZA excipients list
DailyMed Link:SIMBRINZA at DailyMed
Drug patent expirations by year for SIMBRINZA
Drug Prices for SIMBRINZA

See drug prices for SIMBRINZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SIMBRINZA
Generic Entry Date for SIMBRINZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Perrigo CompanyPhase 3
Novartis PharmaceuticalsPhase 4
Cornerstone Health Care, PAPhase 4

See all SIMBRINZA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIMBRINZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting SIMBRINZA

Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alcon Labs Inc SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251-001 Apr 19, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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/003698
Decrease 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 7126
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10262898
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1015996
Estimated Expiration: See Plans and Pricing

Canada

Patent: 63778
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10000634
Estimated Expiration: See Plans and Pricing

China

Patent: 2802604
Estimated Expiration: See Plans and Pricing

Patent: 4707145
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160953
Estimated Expiration: See Plans and Pricing

Patent: 0200979
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17835
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 42790
Estimated Expiration: See Plans and Pricing

Patent: 22035
Estimated Expiration: See Plans and Pricing

Patent: 45164
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 42790
Estimated Expiration: See Plans and Pricing

Patent: 22035
Estimated Expiration: See Plans and Pricing

Patent: 45164
Estimated Expiration: See Plans and Pricing

Patent: 37634
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 63521
Estimated Expiration: See Plans and Pricing

Patent: 94007
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30435
Estimated Expiration: See Plans and Pricing

Patent: 49477
Estimated Expiration: See Plans and Pricing

Japan

Patent: 17956
Estimated Expiration: See Plans and Pricing

Patent: 12530712
Estimated Expiration: See Plans and Pricing

Patent: 14198729
Estimated Expiration: See Plans and Pricing

Patent: 16183198
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 45164
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11013107
Estimated Expiration: See Plans and Pricing

Poland

Patent: 42790
Estimated Expiration: See Plans and Pricing

Patent: 22035
Estimated Expiration: See Plans and Pricing

Patent: 45164
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 42790
Estimated Expiration: See Plans and Pricing

Patent: 22035
Estimated Expiration: See Plans and Pricing

Patent: 45164
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 63125
Estimated Expiration: See Plans and Pricing

Patent: 12101782
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600249
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 42790
Estimated Expiration: See Plans and Pricing

Patent: 22035
Estimated Expiration: See Plans and Pricing

Patent: 45164
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1108384
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1738502
Estimated Expiration: See Plans and Pricing

Patent: 120028390
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61617
Estimated Expiration: See Plans and Pricing

Patent: 84858
Estimated Expiration: See Plans and Pricing

Patent: 03648
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 89997
Estimated Expiration: See Plans and Pricing

Patent: 1100103
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 709
Estimated Expiration: See Plans and Pricing

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 3437634 COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES) See Plans and Pricing
Uruguay 32709 COMPOSICIONES FARMAC√ČUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS BORATO-POLIOL See Plans and Pricing
Taiwan 201100103 Aqueous pharmaceutical compositions containing borate-polyol complexes See Plans and Pricing
Canada 2763778 COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIMBRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 300683 Netherlands See Plans and Pricing 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 92462 Luxembourg See Plans and Pricing 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 2014C/042 Belgium See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.