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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-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in twenty-four 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:23
Applicants:9
NDAs:14
Drug Master File Entries: see list11
Suppliers: see list5
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

Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Status: Completed Condition: Rhegmatogenous Macula-off Retinal Detachment

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;OPHTHALMIC021770-001Aug 19, 2005RXYes6,562,873*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes6,673,337*PED<disabled>Y<disabled>
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, 2007RXYes8,748,425<disabled>Y<disabled>
Sandoz
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC078075-001Jan 30, 2008RXNo<disabled><disabled>
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International Patent Family for Ingredient: brimonidine tartrate

Country Document Number Publication Date
Japan2013523611Jun 17, 2013
Japan5547705Jul 16, 2014
MexicoPA05014107Mar 17, 2006
Japan2012072176Apr 12, 2012
European Patent Office2388007Nov 23, 2011
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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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