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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Novartis
Accenture
McKesson
Chubb
Fuji
Farmers Insurance
Express Scripts
Queensland Health

Generated: November 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 ninety-six patent family members in thirty-three countries and twenty-two supplementary protection certificates in eleven 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.
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
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-003Jan 17, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-002Dec 23, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 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;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-002Dec 23, 1996► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
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
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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
Hungary0203374► Subscribe
Russian Federation2009115778► Subscribe
Cyprus2553► Subscribe
Australia724998► Subscribe
Spain2290400► Subscribe
Japan2012051948► Subscribe
Peru87498► Subscribe
Poland188271► Subscribe
Norway20041287► Subscribe
Russian Federation2453306► 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
90021-9Sweden► SubscribePRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983/02Switzerland► SubscribePRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
C0039Belgium► SubscribePRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
0810Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 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
0811Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
C004Belgium► SubscribePRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
2016 00022Denmark► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
2016000038Germany► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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Serving leading biopharmaceutical companies globally:

Queensland Health
Medtronic
Fuji
Federal Trade Commission
US Army
Chinese Patent Office
Moodys
Fish and Richardson
Baxter
Cantor Fitzgerald

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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