.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

diovan Drug Profile

« Back to Dashboard
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

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<disabled><disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001RXNo6,294,197*PED<disabled>Y<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002RXNo5,972,990*PED<disabled>Y<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: DIOVAN

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 20015,399,578*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: DIOVAN

Country Document Number Estimated Expiration
Canada2259148<disabled in preview>
Norway317181<disabled in preview>
Denmark1767206<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: DIOVAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
80036Netherlands<disabled>PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925
07C/043Belgium<disabled>PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983/02Switzerland<disabled>PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc