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Serving 500+ biopharmaceutical companies globally:

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Generated: July 21, 2017

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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, Sandoz Inc, Bausch And Lomb, Teva Parenteral, Indoco Remedies, 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 forty-eight patent family members in thirty-one countries.

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

Summary for Generic Name: brimonidine tartrate

Tradenames:7
Patents:29
Applicants:8
NDAs:14
Drug Master File Entries: see list11
Suppliers / Packagers: see list11
Bulk Api Vendors: see list79
Clinical Trials: see list211
Patent Applications: see list1,276
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices
DailyMed Link:brimonidine tartrate at DailyMed

Pharmacology for Ingredient: brimonidine tartrate

Tentative approvals for BRIMONIDINE TARTRATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.1%SOLUTION; OPHTHALMIC
► Subscribe► Subscribe0.2%; 0.5%SOLUTION; OPHTHALMIC
► Subscribe► 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
Novartis Pharms Corp
SIMBRINZA
brimonidine tartrate; brinzolamide
SUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYesYes6,316,441► Subscribe ► Subscribe
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708-001Aug 23, 2013RXYesYes8,231,885► SubscribeY ► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001ATRXYesYes6,673,337*PED► SubscribeY► Subscribe
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYesYes7,323,463► SubscribeYY ► Subscribe
Akorn
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC076439-001Mar 14, 2006ATRXNoNo► 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
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20015,736,165*PED► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,194,415*PED► Subscribe
Allergan
ALPHAGAN
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 19966,194,415*PED► Subscribe
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,248,741*PED► Subscribe
Allergan
ALPHAGAN
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 19966,465,464*PED► 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
8,611,848Method and system for providing tiered access to communication network resources► Subscribe
8,892,066Method and system for providing tiered priority access to communication network resources► Subscribe
7,838,563Compounds, formulations, and methods for ameliorating telangiectasias► Subscribe
8,993,571Compounds, formulations, and methods for treating or preventing inflammatory skin disorders► 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
South Africa200209877► Subscribe
Russian Federation2519676► Subscribe
Russian Federation2571277► Subscribe
Norway20056104► Subscribe
Australia2001273268► 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
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
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
1 5019-2014Slovakia► SubscribePRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
2014 00031Denmark► SubscribePRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
C0056France► SubscribePRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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:

Merck
US Department of Justice
Mallinckrodt
McKesson
Covington
Citi
US Army
Daiichi Sankyo
Chubb
QuintilesIMS

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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