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Profile for Tradename: EDARBI

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Edarbi is a drug marketed by Arbor Pharms Ireland and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug.

This drug has forty-six patent family members in twenty-six countries.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.

Summary for Tradename: EDARBI

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list10

Pharmacology for Tradename: EDARBI

Clinical Trials for: EDARBI

A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
Status: Terminated Condition: Hypertension

A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
Status: Completed Condition: Essential Hypertension

TAK-491 (Azilsartan Medoxomil) Compared to Valsartan in Chinese Participants With Hypertension
Status: Not yet recruiting Condition: Essential Hypertension

Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients
Status: Recruiting Condition: Hypertension; Obesity; Type 2 Diabetes Mellitus

Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
Status: Completed Condition: Hypertension

Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
Status: Completed Condition: Grade I or II Essential Hypertension

Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension
Status: Completed Condition: Essential Hypertension

Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension
Status: Completed Condition: Hypertension

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
Arbor Pharms Ireland
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXNo7,572,920<disabled>Y<disabled>
Arbor Pharms Ireland
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYes7,572,920<disabled>Y<disabled>
Arbor Pharms Ireland
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXNo7,157,584<disabled>Y<disabled>
Arbor Pharms Ireland
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-001Feb 25, 2011RXNo<disabled><disabled>
Arbor Pharms Ireland
EDARBI
azilsartan kamedoxomil
TABLET;ORAL200796-002Feb 25, 2011RXYes<disabled><disabled>
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International Patent Family for Tradename: EDARBI

Country Document Number Publication Date
New Zealand549755Apr 30, 2009
China1946717Apr 11, 2007
China101381366Mar 11, 2009
Hong Kong1098472Feb 01, 2008
Australia2005214271Feb 24, 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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