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DIOVAN HCT Drug Profile

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

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

The generic ingredient in DIOVAN HCT 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 HCT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list8
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>
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Expired Patents for Tradename: DIOVAN HCT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-001Mar 6, 19985,399,578*PED<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 20065,399,578*PED<disabled>
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-003Jan 17, 20025,399,578*PED<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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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 HCT

Country Document Number Estimated Expiration
European Patent Office1776953<disabled in preview>
South Korea101208430<disabled in preview>
Israel127564<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 HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/037United Kingdom<disabled>PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
C0030France<disabled>PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
2011 00026Denmark<disabled>PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
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