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Generated: December 17, 2017

DrugPatentWatch Database Preview

Brimonidine tartrate - Generic Drug Details

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

Brimonidine tartrate
is the generic ingredient in seven branded drugs marketed by Galderma Labs Lp, Allergan, Akorn, Bausch And Lomb, Indoco Remedies, Sandoz Inc, Teva Parenteral, and Novartis Pharms Corp, and is included in fourteen NDAs. There are twenty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Brimonidine tartrate has one hundred and seventy-one patent family members in thirty-one countries and eleven supplementary protection certificates in ten countries.

There are eleven drug master file entries for brimonidine tartrate. Twelve suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for brimonidine tartrate

Pharmacology for brimonidine tartrate

Medical Subject Heading (MeSH) Categories for brimonidine tartrate

Tentative approvals for BRIMONIDINE TARTRATE

Applicant Application No. Strength Dosage Form
u► Subscribe0.1%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 Product Substance Delist Req. Exclusivity Expiration
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpSIMBRINZAbrimonidine tartrate; brinzolamideSUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Sandoz IncQOLIANAbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021764-001May 22, 2006ATRXNoNo► Subscribe► SubscribeY► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► SubscribeYY► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001ATRXYesYes► Subscribe► SubscribeY► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001ATRXYesYes► Subscribe► SubscribeY► Subscribe
AllerganCOMBIGANbrimonidine tartrate; timolol maleateSOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes► Subscribe► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001ATRXYesYes► Subscribe► SubscribeY► Subscribe
AkornBRIMONIDINE TARTRATEbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC076439-001Mar 14, 2006ATRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: brimonidine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001► Subscribe► Subscribe
AllerganALPHAGANbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 1996► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001► Subscribe► Subscribe
AllerganALPHAGANbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 1996► Subscribe► Subscribe
AllerganALPHAGANbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 1996► Subscribe► Subscribe
AllerganALPHAGAN Pbrimonidine tartrateSOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: brimonidine tartrate

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
9,258,687Method and system for providing tiered access to communication network resources► Subscribe
7,838,563Compounds, formulations, and methods for ameliorating telangiectasias► Subscribe
8,611,848Method and system for providing tiered access to communication network resources► Subscribe
8,275,349Method and system for providing tiered priority access to communication network resources► Subscribe
8,993,571Compounds, formulations, and methods for treating or preventing inflammatory skin disorders► Subscribe
8,892,066Method and system for providing tiered priority access to communication network resources► Subscribe
8,586,586Methods and compositions for treating or preventing erythema► Subscribe
8,557,817Compounds, formulations, and methods for treating or preventing inflammatory skin disorders► 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

Country Document Number Estimated Expiration
Norway333468► Subscribe
Hungary0303197► Subscribe
South Korea101257046► Subscribe
SloveniaEP1761266► Subscribe
Australia2005280259► Subscribe
Slovenia1631293► Subscribe
China101897704► Subscribe
European Patent Office2481412► Subscribe
Austria530185► Subscribe
Poland360707► 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

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
2014000080Germany► SubscribePRODUCT NAME: BRIMONIDIN UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/904 20140221
1 5019-2014Slovakia► SubscribePRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
14/041Ireland► SubscribePRODUCT NAME: BRIMONIDINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/904 20140221
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
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
0140022 00150Estonia► SubscribePRODUCT NAME: BRIMONIDIIN;REG NO/DATE: K(2014)1313 (LOPLIK) 25.02.2014
1631293/01Switzerland► SubscribePRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
2014 00031Denmark► SubscribePRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
90049-2Sweden► SubscribePRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Queensland Health
Cerilliant
Mallinckrodt
Cantor Fitzgerald
Daiichi Sankyo
Healthtrust
Dow
Chinese Patent Office

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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