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Details for Generic Name: brimonidine tartrate

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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, Indoco Remedies, Sandoz, Teva Parenteral, and Alcon Res Ltd, and is included in fourteen NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-eight patent family members in twenty-seven countries.

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

Summary for Generic Name: brimonidine tartrate

Tradenames:7
Patents:24
Applicants:9
NDAs:14
Drug Master File Entries: see list11
Suppliers / Packaging: see list20
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

Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
Status: Completed Condition: Vitrectomy

Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Status: Completed Condition: Erythematous Rosacea

Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Status: Completed Condition: Macular Degeneration

An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Status: Completed Condition: Retinitis Pigmentosa

Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Status: Not yet recruiting Condition: Corneal Edema; Visual Acuity

Brimonidine Tartrate for the Treatment of Injection Related Erythema
Status: Not yet recruiting Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes7,320,976<disabled> <disabled>
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes7,030,149<disabled> <disabled>
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398-001Oct 30, 2007RXYes7,323,463<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: brimonidine tartrate

These historical archives are available as an add-on to one-year subscriptions

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, 20015,424,078*PED<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 20015,736,165*PED<disabled>
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International Patent Family for Ingredient: brimonidine tartrate

Country Document Number Publication Date
China102743380Aug 12, 2015
Norway20056104Feb 03, 2006
Canada2753754Jun 09, 2015
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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