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Profile for Tradename: BENICAR

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Summary for Tradename: BENICAR

Patents:2
Applicants:1
NDAs:2
Suppliers: see list9
2013 Sales:$832,276,000

Pharmacology for Tradename: BENICAR

Clinical Trials for: BENICAR

Drug Interaction Study of Olmesartan in Healthy Chinese Volunteers
Status: Completed Condition: Drug Interaction of Olmesartan in Healthy Chinese Volunteers

Olmesartan Pediatric Pharmacokinetic (PK) Study
Status: Completed Condition: Hypertension

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension
Status: Completed Condition: Essential Hypertension

Olmesartan in Essential Hypertension
Status: Completed Condition: Essential Hypertension

Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Status: Completed Condition: Hypertension

Assessment of the Effectiveness of OLMETECĀ® and OLMETEC PLUSĀ® for Treatment of Hypertension in Stage I and II Patients (Study P05254)(COMPLETED)
Status: Completed Condition: Hypertension

Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension
Status: Completed Condition: Essential Hypertension

Effect of Two Doses of Olmesartan Medoxomil and Amlodipine on Vascular Markers in Hypertensive Patients With Metabolic Syndrome
Status: Completed Condition: Metabolic Syndrome; Hypertension

Olmesartan Comparison to Losartan in Hypertensive Subjects
Status: Completed Condition: Hypertension

Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension
Status: Completed Condition: Essential Hypertension

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
BENICAR HCT
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532Jun 5, 2003RXNo5,616,599*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286Apr 25, 2002RXYes5,616,599*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286Apr 25, 2002RXYes6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286Apr 25, 2002RXNo5,616,599*PED<disabled>Y<disabled>
Daiichi Sankyo
BENICAR
olmesartan medoxomil
TABLET;ORAL021286Apr 25, 2002RXYes<disabled><disabled>
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Paragraph IV activity for: BENICAR

Drugname Dosage Strength RLD Submissiondate
olmesartan medoxomil and hydrochlorothiazideTablets20 mg/12.5 mgBenicar HCT5/11/2007
olmesartan medoxomil and hydrochlorothiazideTablets40 mg/12.5 mg and 40 mg/25 mLBenicar HCT2/15/2007
olmesartan medoxomilTablets5 mg, 20 mg and 40 mgBenicar4/25/2006
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