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Profile for Tradename: diovan

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Diovan is a drug marketed by Novartis and is included in three NDAs. It is available from twelve suppliers. There are two patents protecting this drug and three Paragraph IV challenges.

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

Summary for Tradename: diovan

Suppliers / Packagers: see list68
2013 Sales:$2,169,819,000

Pharmacology for Tradename: diovan

Clinical Trials for: diovan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
CAPSULE;ORAL020665-001Dec 23, 1996DISCNNo<disabled><disabled>
TABLET;ORAL021283-002Jul 18, 2001RXNo6,294,197*PED<disabled>Y<disabled>
TABLET;ORAL021283-004Aug 14, 2002RXNo5,972,990*PED<disabled>Y<disabled>
hydrochlorothiazide; valsartan
TABLET;ORAL020818-002Mar 6, 1998RXNo6,294,197*PED<disabled>Y<disabled>
TABLET;ORAL021283-002Jul 18, 2001RXNo5,972,990*PED<disabled>Y<disabled>
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Paragraph IV activity for: DIOVAN

Drugname Dosage Strength RLD Submissiondate
valsartan and hydrochlorothiazideTablets320 mg/12.5 mg and 320 mg/25 mgDiovan HCT2/7/2007
valsartan and hydrochlorothiazideTablets80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mgDiovan HCT12/2/2005
valsartanTablets40 mg, 80 mg,160 mgDiovan12/28/2004
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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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