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

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

DIOVAN Drug Profile

« Back to Dashboard

Which patents cover Diovan, and what substitute generic drugs are available?

Diovan is a drug marketed by Novartis and is included in three NDAs. 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. Thirty-one 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
Bulk Api Vendors: see list85
Clinical Trials: see list10
Patent Applications: see list6,212
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DIOVAN at DailyMed

Pharmacology for Tradename: DIOVAN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996DISCNNoNo► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001RXYesNo5,972,990*PED► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002RXYesNo6,294,197*PED► SubscribeY► Subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-002Mar 6, 1998RXYesNo6,294,197*PED► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001RXYesNo6,294,197*PED► SubscribeY► Subscribe
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 20015,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 20015,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-002Dec 23, 19965,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED► Subscribe
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► Subscribe
6,858,228 Solid oral dosage forms of valsartan► Subscribe
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims► Subscribe
6,485,745 Solid oral dosage forms of valsartan► Subscribe
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
Germany69739642► Subscribe
Austria276750► Subscribe
Poland188271► Subscribe
New Zealand333385► Subscribe
Portugal1767206► Subscribe
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
2016017Lithuania► SubscribePRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
C0039Belgium► SubscribePRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
0443983/02Switzerland► SubscribePRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0811Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
/1997Austria► SubscribePRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513
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 our clients use DrugPatentWatch

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc