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Last Updated: July 14, 2020

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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 freedom to operate?

Brimonidine tartrate; brinzolamide is the generic ingredient in one branded drug marketed by Novartis 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 forty-one patent family members in twenty-five countries.

There are eleven drug master file entries for brimonidine tartrate; brinzolamide. One supplier is listed for this compound.

Summary for brimonidine tartrate; brinzolamide
International Patents:41
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 11
Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:brimonidine tartrate; brinzolamide at DailyMed
Recent Clinical Trials for brimonidine tartrate; brinzolamide

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

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

See all brimonidine tartrate; brinzolamide clinical trials

Pharmacology for brimonidine tartrate; brinzolamide

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

Supplementary Protection Certificates for brimonidine tartrate; brinzolamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 300683 Netherlands   Start 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   Start 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   Start Trial PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293 2014/041 Ireland   Start Trial PRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
1631293 C300683 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
AstraZeneca
McKesson
Express Scripts
Mallinckrodt

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