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Brimonidine tartrate - Generic Drug Details

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

This ingredient has one hundred and forty 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:25
Applicants:9
NDAs:14
Drug Master File Entries: see list11
Suppliers / Packaging: see list11
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: brimonidine tartrate

Tentative approvals for BRIMONIDINE TARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC0.1%
<disabled><disabled>SOLUTION; OPHTHALMIC0.2%; 0.5%
<disabled><disabled>SOLUTION; OPHTHALMIC0.2%; 0.5%

Clinical Trials for: brimonidine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,627,210*PED<disabled>Y<disabled>
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708-001Aug 23, 2013RXYes8,053,427<disabled>Y <disabled>
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes7,030,149<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: brimonidine tartrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,248,741*PED<disabled>
Allergan
ALPHAGAN
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 19966,194,415*PED<disabled>
Allergan
ALPHAGAN
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 19966,465,464*PED<disabled>
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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
8,557,817Compounds, formulations, and methods for treating or preventing inflammatory skin disorders<disabled in preview>
8,275,349Method and system for providing tiered priority access to communication network resources<disabled in preview>
8,892,066Method and system for providing tiered priority access to communication network resources<disabled in preview>
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International Patent Family for Ingredient: brimonidine tartrate

Country Document Number Estimated Expiration
New Zealand521185<disabled in preview>
Israel153322<disabled in preview>
Australia2001273268<disabled in preview>
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Supplementary Protection Certificates for Tradename: BRIMONIDINE TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00683Netherlands<disabled>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
1 5019-2014Slovakia<disabled>PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
2014 00031Denmark<disabled>PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
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