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Profile for Tradename: ALPHAGAN P

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Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ALPHAGAN P is brimonidine tartrate. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for Tradename: ALPHAGAN P

Patents:5
Applicants:1
NDAs:2
Suppliers: see list2

Pharmacology for Tradename: ALPHAGAN P

Clinical Trials for: ALPHAGAN P

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

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

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

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

Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs
Status: Completed Condition: Primary Open Angle Glaucoma; Ocular Hypertension

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

A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
Status: Completed Condition: Glaucoma; Ocular Hypertension

Effect of Brimonidine on Corneal Thickness
Status: Recruiting Condition: Impact of Brimonidine on the Cornea

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

Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Status: Completed Condition: Glaucoma, Open-Angle

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
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes8,858,961*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,641,834*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes6,627,210*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021262-001Mar 16, 2001RXYes6,627,210*PED<disabled>Y<disabled>
Allergan
ALPHAGAN P
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC021770-001Aug 19, 2005RXYes6,673,337*PED<disabled>Y<disabled>
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Paragraph IV activity for: ALPHAGAN P

Drugname Dosage Strength RLD Submissiondate
brimonidine tartrateOphthalmic Solution0.10%Alphagan P12/20/2006
brimonidine tartrateOphthalmic Solution0.15%Alphagan P11/3/2006
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Preferred citation:

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

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