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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: see list9
2013 Sales:$832,276,000

Pharmacology for Tradename: BENICAR

Clinical Trials for: BENICAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-003Jun 5, 2003RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
olmesartan medoxomil
TABLET;ORAL021286-001Apr 25, 2002RXNo6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
olmesartan medoxomil
TABLET;ORAL021286-004Apr 25, 2002RXYes6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-005Jun 5, 2003RXYes6,878,703*PED<disabled>Y<disabled>
Daiichi Sankyo
hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL021532-002Jun 5, 2003RXNo5,616,599*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
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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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