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

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:8
NDAs:13
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

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

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

The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
Status: Not yet recruiting Condition: Healthy

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;OPHTHALMIC021262Mar 16, 2001RXYes6,562,873*PED<disabled>Y<disabled>
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708Aug 23, 2013RXYes8,513,247<disabled>Y<disabled>
Allergan
COMBIGAN
brimonidine tartrate; timolol maleate
SOLUTION/DROPS;OPHTHALMIC021398Oct 30, 2007RXYes8,133,890<disabled><disabled>
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708Aug 23, 2013RXYes8,231,885<disabled>Y<disabled>
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708Aug 23, 2013RXYes8,426,410<disabled><disabled>
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