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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-two 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
Drug Prices:see low prices

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
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708-001Aug 23, 2013RXYes8,513,249Mar 25, 2031Y
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,641,834*PEDJan 28, 2022Y
Akorn
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC076439-001Mar 14, 2006RXNo
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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
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 19966,194,415*PED<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20016,248,741*PED<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20015,424,078*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
8,892,066Method and system for providing tiered priority access to communication network resources<disabled in preview>
8,557,817Compounds, formulations, and methods for treating or preventing inflammatory skin disorders<disabled in preview>
8,586,586Methods and compositions for treating or preventing erythema<disabled in preview>
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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
Canada2416169<disabled in preview>
Slovenia2388007<disabled in preview>
BrazilPI0514723<disabled in preview>
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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
1 5019-2014Slovakia<disabled>PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221
462Luxembourg<disabled>PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225
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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