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Serving leading biopharmaceutical companies globally:

Baxter
Julphar
Accenture
Mallinckrodt
McKesson
Johnson and Johnson
Daiichi Sankyo
Colorcon
QuintilesIMS
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Brimonidine tartrate; timolol maleate - Generic Drug Details

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What are the generic drug sources for brimonidine tartrate; timolol maleate and what is the scope of brimonidine tartrate; timolol maleate freedom to operate?

Brimonidine tartrate; timolol maleate
is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate; timolol maleate has twenty-six patent family members in nineteen countries and five supplementary protection certificates in four countries.

There are eleven drug master file entries for brimonidine tartrate; timolol maleate. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for brimonidine tartrate; timolol maleate

Pharmacology for brimonidine tartrate; timolol maleate

Tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant Application No. Strength Dosage Form
u► Subscribe0.2%; 0.5%SOLUTION; OPHTHALMIC
u► Subscribe0.2%; 0.5%SOLUTION; OPHTHALMIC
u► Subscribe0.2%; 0.5%SOLUTION; OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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International Patent Family for Ingredient: brimonidine tartrate; timolol maleate

Country Document Number Estimated Expiration
South Korea100723189► Subscribe
TaiwanI351959► Subscribe
China101664414► Subscribe
SloveniaEP1496912► Subscribe
World Intellectual Property Organization (WIPO)03088973► Subscribe
European Patent Office1496912► Subscribe
European Patent Office2241319► Subscribe
MexicoPA03008401► Subscribe
China100558364► Subscribe
Portugal1496912► 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; TIMOLOL MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0056France► SubscribePRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
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
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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Serving leading biopharmaceutical companies globally:

Healthtrust
AstraZeneca
Fish and Richardson
Cipla
Teva
McKinsey
Merck
Deloitte
US Department of Justice
Baxter

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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