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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 patent family members in twenty-five 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

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

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
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
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC020613-001Sep 6, 1996DISCNNo<disabled><disabled>
Alcon Res Ltd
brimonidine tartrate; brinzolamide
SUSPENSION/DROPS;OPHTHALMIC204251-001Apr 19, 2013RXYes9,044,484<disabled>Y<disabled>
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,627,210*PED<disabled>Y<disabled>
Alcon Pharms Ltd
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC076254-001Sep 16, 2003RXNo<disabled><disabled>
Indoco Remedies
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC091691-001Nov 18, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: brimonidine tartrate

Country Document Number Publication Date
European Patent Office1761266Nov 11, 2009
Canada2753754Sep 03, 2009
World Intellectual Property Organization (WIPO)2009108785Dec 30, 2009
European Patent Office2629757Aug 28, 2013
World Intellectual Property Organization (WIPO)2011117377Sep 29, 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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