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Daiichi Sankyo
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Baxter
Merck
Cipla
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Generated: August 16, 2017

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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 brimonidine tartrate; brinzolamide patent protection?

Brimonidine tartrate; brinzolamide
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; brinzolamide has thirty patent family members in twenty-three countries.

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

Summary for Generic Name: brimonidine tartrate; brinzolamide

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Clinical Trials: see list234
Drug Prices:see low prices
DailyMed Link:brimonidine tartrate; brinzolamide at DailyMed

Pharmacology for Ingredient: 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 Pharms Corp
SIMBRINZA
brimonidine tartrate; brinzolamide
SUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
SIMBRINZA
brimonidine tartrate; brinzolamide
SUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
SIMBRINZA
brimonidine tartrate; brinzolamide
SUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: brimonidine tartrate; brinzolamide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,242,442 Brinzolamide and brimonidine for treating ocular conditions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: brimonidine tartrate; brinzolamide

Country Document Number Estimated Expiration
Slovenia2722035► Subscribe
Portugal2722035► Subscribe
Japan2012530712► Subscribe
Spain2461617► Subscribe
Portugal2442790► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BRIMONIDINE TARTRATE; BRINZOLAMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
462Luxembourg► SubscribePRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
C0056France► SubscribePRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
0683Netherlands► SubscribePRODUCT 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
14/041Ireland► SubscribePRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
00683Netherlands► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Covington
US Army
Express Scripts
Baxter
Novartis
Fish and Richardson
US Department of Justice
Healthtrust

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 verifification 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.

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