You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

~ Buy the SIMBRINZA (brimonidine tartrate; brinzolamide) Drug Profile, 2024 PDF Report in the Report Store ~

SIMBRINZA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for SIMBRINZA
Drug Prices for SIMBRINZA

See drug prices for SIMBRINZA

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
AllerganPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Aqueous pharmaceutical compositions containing borate-polyol complexes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alcon Labs Inc SIMBRINZA brimonidine tartrate; brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204251-001 Apr 19, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 2017
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 10262898
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 1015996
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 63778
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 10000634
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2802604
Estimated Expiration: ⤷  Try a Trial

Patent: 4707145
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160953
Estimated Expiration: ⤷  Try a Trial

Patent: 0200979
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17835
Estimated Expiration: ⤷  Try a Trial

Patent: 23120
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 42790
Estimated Expiration: ⤷  Try a Trial

Patent: 22035
Estimated Expiration: ⤷  Try a Trial

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 42790
Estimated Expiration: ⤷  Try a Trial

Patent: 22035
Estimated Expiration: ⤷  Try a Trial

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

Patent: 37634
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 63521
Estimated Expiration: ⤷  Try a Trial

Patent: 94007
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 30435
Estimated Expiration: ⤷  Try a Trial

Patent: 49477
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 17956
Estimated Expiration: ⤷  Try a Trial

Patent: 12530712
Estimated Expiration: ⤷  Try a Trial

Patent: 14198729
Estimated Expiration: ⤷  Try a Trial

Patent: 16183198
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11013107
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 42790
Estimated Expiration: ⤷  Try a Trial

Patent: 22035
Estimated Expiration: ⤷  Try a Trial

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 42790
Estimated Expiration: ⤷  Try a Trial

Patent: 22035
Estimated Expiration: ⤷  Try a Trial

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 63125
Estimated Expiration: ⤷  Try a Trial

Patent: 12101782
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600249
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 42790
Estimated Expiration: ⤷  Try a Trial

Patent: 22035
Estimated Expiration: ⤷  Try a Trial

Patent: 45164
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1108384
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1738502
Estimated Expiration: ⤷  Try a Trial

Patent: 120028390
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 61617
Estimated Expiration: ⤷  Try a Trial

Patent: 84858
Estimated Expiration: ⤷  Try a Trial

Patent: 03648
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 89997
Estimated Expiration: ⤷  Try a Trial

Patent: 1100103
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 709
Estimated Expiration: ⤷  Try a Trial

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
Croatia P20160953 ⤷  Try a Trial
Denmark 2722035 ⤷  Try a Trial
European Patent Office 3437634 COMPOSITIONS PHARMACEUTIQUES AQUEUSES CONTENANT DES COMPLEXES DE BORATE-POLYOL (AQUEOUS PHARMACEUTICAL COMPOSITIONS CONTAINING BORATE-POLYOL COMPLEXES) ⤷  Try a Trial
Portugal 3045164 ⤷  Try a Trial
Japan 6017956 ⤷  Try a Trial
Portugal 2722035 ⤷  Try a Trial
Poland 3045164 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIMBRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 C300683 Netherlands ⤷  Try a Trial 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 2014C/042 Belgium ⤷  Try a Trial 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 300683 Netherlands ⤷  Try a Trial 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 ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014/041 Ireland ⤷  Try a Trial 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

Make Better Decisions: Try a trial or see plans & pricing

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.