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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 eleven 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 list59
2013 Sales:$2,169,819,000

Pharmacology for Tradename: diovan

Clinical Trials for: diovan

ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria
Status: Completed Condition: Hypertension; Diabetes Mellitus, Type 2; Albuminuria

Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Status: Recruiting Condition: Hypertrophic Cardiomyopathy

To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Status: Completed Condition: Hypertension; High Blood Pressure

Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Status: Completed Condition: Essential Hypertension

Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Status: Completed Condition: Hypertension, Hyperlipidemia

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease
Status: Terminated Condition: Proteinuric Kidney Disease; Diabetic Nephropathy; Hypertensive Nephrosclerosis; IgA Nephropathy; Focal Segmental Glomerulosclerosis; Glomerulopathy (Obesity-associated); Glomerulonephritis, Membranous

Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
Status: Completed Condition: Diabetes Mellitus, Type 2

Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg
Status: Completed Condition: Hypertension; Hyperlipidemia

Bioequivalence Evaluation of Two Film-Coated Formulations of Valsartan 160 mg
Status: Completed Condition: Healthy

Courtesy of
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
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>
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Expired Patents for Tradename: DIOVAN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED<disabled>
TABLET;ORAL021283-002Jul 18, 20015,399,578*PED<disabled>
TABLET;ORAL021283-001Jul 18, 20015,399,578*PED<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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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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