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Last Updated: November 2, 2024

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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 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

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Drug patent expirations by year for SIMBRINZA
Drug Prices for SIMBRINZA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alcon Labs Inc SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251-001 Apr 19, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: COMPOSICIONES FARMACEUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS DE BORATO-POLIOL
Estimated Expiration: ⤷  Sign Up

Patent: 2017
Patent: COMPOSICIONES FARMACÉUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS DE BORATO-POLIOL
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10262898
Patent: Aqueous pharmaceutical compositions containing borate-polyol complexes
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 1015996
Patent: composições farmacêuticas aquosas contendo complexos de borato-poliol
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 63778
Patent: COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 10000634
Patent: Composicion oftalmica multidosis que comprende un primer poliol seleccionado de manitol y/o sorbitol, un segundo poliol seleccionado de propilenglicol y/o glicerina, borato en cantidad menor a 0,5% en p/v, cloruro de benzalconio en concentracion de 0.0007%-0,0035% p/v y agua y uso para el tratamiento de la presion intraocular elevada.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2802604
Patent: Aqueous pharmaceutical compositions containing borate-polyol complexes
Estimated Expiration: ⤷  Sign Up

Patent: 4707145
Patent: Aqueous pharmaceutical compositions containing borate-polyol complexes
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160953
Estimated Expiration: ⤷  Sign Up

Patent: 0200979
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17835
Estimated Expiration: ⤷  Sign Up

Patent: 23120
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 42790
Estimated Expiration: ⤷  Sign Up

Patent: 22035
Estimated Expiration: ⤷  Sign Up

Patent: 45164
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 42790
Patent: COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES BORATE-POLYOLS (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Patent: 22035
Patent: Compositions pharmaceutiques aqueuses contenant des complexes de borate-polyol (Aqueous pharmaceutical compositions containing borate-polyol complexes)
Estimated Expiration: ⤷  Sign Up

Patent: 45164
Patent: COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Patent: 37634
Patent: COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 63521
Patent: 含有硼酸鹽多元醇混合物的水溶性藥物組合物 (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Patent: 94007
Patent: 含有硼酸鹽多元醇混合物的水溶性藥物組合物 (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 30435
Estimated Expiration: ⤷  Sign Up

Patent: 49477
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 17956
Estimated Expiration: ⤷  Sign Up

Patent: 12530712
Estimated Expiration: ⤷  Sign Up

Patent: 14198729
Patent: ボレート−ポリオール複合体を含む水性薬学的組成物 (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Patent: 16183198
Patent: ボレート−ポリオール複合体を含む水性薬学的組成物 (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 45164
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11013107
Patent: COMPOSICIONES FARMACEUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS DE BORATO - POLIOL. (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 42790
Estimated Expiration: ⤷  Sign Up

Patent: 22035
Estimated Expiration: ⤷  Sign Up

Patent: 45164
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 42790
Estimated Expiration: ⤷  Sign Up

Patent: 22035
Estimated Expiration: ⤷  Sign Up

Patent: 45164
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 63125
Patent: ВОДНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ БОРАТПОЛИОЛ (AQUEOUS PHARMACEUTICAL COMPOSITIONS, CONTAINING BORATE-POLYOL COMPLEXES)
Estimated Expiration: ⤷  Sign Up

Patent: 12101782
Patent: ВОДНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ БОРАТПОЛИОЛ
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600249
Patent: COMPOSIZIONI FARMACEUTICHE ACQUOSE CONTENENTI COMPLESSI BORATO- POLIOLO
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 42790
Estimated Expiration: ⤷  Sign Up

Patent: 22035
Estimated Expiration: ⤷  Sign Up

Patent: 45164
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1108384
Patent: AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEX
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1738502
Estimated Expiration: ⤷  Sign Up

Patent: 120028390
Patent: AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 61617
Estimated Expiration: ⤷  Sign Up

Patent: 84858
Estimated Expiration: ⤷  Sign Up

Patent: 03648
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 89997
Estimated Expiration: ⤷  Sign Up

Patent: 1100103
Patent: Aqueous pharmaceutical compositions containing borate-polyol complexes
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 709
Patent: COMPOSICIONES FARMACÉUTICAS ACUOSAS QUE CONTIENEN COMPLEJOS BORATO-POLIOL
Estimated Expiration: ⤷  Sign Up

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
Cyprus 1117835 ⤷  Sign Up
Croatia P20160953 ⤷  Sign Up
Japan 2012530712 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIMBRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 92462 Luxembourg ⤷  Sign Up 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 ⤷  Sign Up 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 2014/041 Ireland ⤷  Sign Up PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
>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.