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Last Updated: November 22, 2024

BRIMONIDINE TARTRATE; BRINZOLAMIDE - Generic Drug Details


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What are the generic sources for brimonidine tartrate; brinzolamide and what is the scope of patent protection?

Brimonidine tartrate; brinzolamide is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; brinzolamide has fifty-one patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for BRIMONIDINE TARTRATE; BRINZOLAMIDE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Generic Entry Date for BRIMONIDINE TARTRATE; BRINZOLAMIDE*:
Constraining patent/regulatory exclusivity:
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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alcon ResearchPhase 2
Hermann Eye CenterN/A
Alcon ResearchN/A

See all BRIMONIDINE TARTRATE; BRINZOLAMIDE clinical trials

Pharmacology for BRIMONIDINE TARTRATE; BRINZOLAMIDE
Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; BRINZOLAMIDE
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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

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 BRIMONIDINE TARTRATE; BRINZOLAMIDE

Country Patent Number Title Estimated Expiration
Chile 2010000634 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. ⤷  Sign Up
Poland 3045164 ⤷  Sign Up
Japan 2016183198 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) ⤷  Sign Up
Portugal 2442790 ⤷  Sign Up
Spain 2803648 ⤷  Sign Up
Spain 2584858 ⤷  Sign Up
Spain 2461617 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRIMONIDINE TARTRATE; BRINZOLAMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 300683 Netherlands ⤷  Sign Up 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 ⤷  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 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 2014/041 Ireland ⤷  Sign Up PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 C300683 Netherlands ⤷  Sign Up 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 14C0056 France ⤷  Sign Up 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.