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Deloitte
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021283

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NDA 021283 describes DIOVAN, which is a drug marketed by Novartis and is included in three NDAs. It is available from ten suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the DIOVAN profile page.

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 021283

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021283

Suppliers and Packaging for NDA: 021283

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIOVAN valsartan TABLET;ORAL 021283 NDA Novartis Pharmaceuticals Corporation 0078-0358 0078-0358-34 90 TABLET in 1 BOTTLE (0078-0358-34)
DIOVAN valsartan TABLET;ORAL 021283 NDA Novartis Pharmaceuticals Corporation 0078-0359 0078-0359-34 90 TABLET in 1 BOTTLE (0078-0359-34)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jul 18, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 26, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jul 18, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 26, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021283

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisDIOVANvalsartanTABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-002Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-001Jul 18, 2001► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-004Aug 14, 2002► Subscribe► Subscribe
NovartisDIOVANvalsartanTABLET;ORAL021283-003Jul 18, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Dow
Teva
Citi
Colorcon
Accenture
Fish and Richardson
Express Scripts
US Department of Justice
Covington
Federal Trade Commission

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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