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DIOVAN Drug Profile

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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.

This drug has eighty-eight patent family members in thirty-three countries.

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

Summary for Tradename: DIOVAN

Patents:2
Applicants:1
NDAs:3
Suppliers / Packagers: see list11
Drug Prices: :see details

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
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996DISCNNo
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001RXNo5,972,990*PEDApr 26, 2017Y
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002RXNo6,294,197*PEDDec 18, 2017Y
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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
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 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

Non-Orange Book Patents for Tradename: DIOVAN

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
5,952,305 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims<disabled in preview>
6,858,228 Solid oral dosage forms of valsartan<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: DIOVAN

Country Document Number Estimated Expiration
Malaysia146868<disabled in preview>
South Africa9705673<disabled in preview>
China1475207<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DIOVAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
074Luxembourg<disabled>PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123
0443983/03Switzerland<disabled>PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C004Belgium<disabled>PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
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