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Profile for Tradename: BENICAR

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Benicar is a drug marketed by Daiichi Sankyo and is included in two NDAs. It is available from nine suppliers. There are two patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.

Summary for Tradename: BENICAR

Suppliers / Packagers: see list36
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

Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)
Status: Recruiting Condition: Coronary Atherosclerosis

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

Olmesartan in 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

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

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

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
Status: Completed Condition: Essential Hypertension

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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
Daiichi Sankyo
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 2002RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
olmesartan medoxomil
TABLET;ORAL021286-003Apr 25, 2002RXNo5,616,599*PED<disabled>Y<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

Non-Orange Book Patents for Tradename: BENICAR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,646,171 Angiotensin II antagonist 1-biphenylmethylimidazole compounds and their therapeutic use<disabled in preview>
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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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