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Serving 500+ biopharmaceutical companies globally:

Covington
Queensland Health
AstraZeneca
Deloitte
Fuji
Moodys
QuintilesIMS
Healthtrust
Mallinckrodt
Cantor Fitzgerald

Generated: August 21, 2017

DrugPatentWatch Database Preview

DIOVAN Drug Profile

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What is the patent landscape for Diovan, and what generic Diovan alternatives 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. Twenty-nine 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 list10
Bulk Api Vendors: see list85
Clinical Trials: see list20
Patent Applications: see list5,347
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-002Mar 6, 1998ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: DIOVAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
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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► Subscribe
6,485,745 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
6,858,228 Solid oral dosage forms of valsartan► Subscribe
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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
European Patent Office1774967► Subscribe
European Patent Office1262175► Subscribe
South Korea20090099020► Subscribe
Hungary0203374► Subscribe
Israel127564► Subscribe
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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
/2016Austria► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
90021-9Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
C/GB97/009United Kingdom► SubscribePRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
80036Netherlands► SubscribePRODUCT 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
2016017Lithuania► SubscribePRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
Healthtrust
Daiichi Sankyo
Farmers Insurance
AstraZeneca
Citi
Julphar
Merck
Medtronic
Colorcon

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.

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