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Profile for Tradename: DIOVAN HCT

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Diovan Hct is a drug marketed by Novartis and is included in one NDA. It is available from nine suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in DIOVAN HCT 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 HCT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list85
Formulation / Manufacturing:see details

Pharmacology for Tradename: DIOVAN HCT

Clinical Trials for: DIOVAN HCT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-001Mar 6, 1998RXNo6,294,197*PED<disabled>Y<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-003Jan 17, 2002RXNo6,294,197*PED<disabled>Y<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-002Mar 6, 1998RXNo6,294,197*PED<disabled>Y<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-004Apr 28, 2006RXNo6,294,197*PED<disabled>Y<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 2006RXYes6,294,197*PED<disabled>Y<disabled>
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Paragraph IV activity for: DIOVAN HCT

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

Non-Orange Book Patents for Tradename: DIOVAN HCT

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
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
6,858,228 Solid oral dosage forms of valsartan<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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