➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
McKesson
Colorcon
Harvard Business School
AstraZeneca

Last Updated: August 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020818

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 020818 describes DIOVAN HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. Additional details are available on the DIOVAN HCT profile page.

The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 020818
Tradename:DIOVAN HCT
Applicant:Novartis
Ingredient:hydrochlorothiazide; valsartan
Patents:0
Pharmacology for NDA: 020818
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 020818
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818 NDA Novartis Pharmaceuticals Corporation 0078-0314 0078-0314-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34)
DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818 NDA Novartis Pharmaceuticals Corporation 0078-0315 0078-0315-34 90 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34)
Paragraph IV (Patent) Challenges for 020818
Tradename Dosage Ingredient NDA Submissiondate
DIOVAN HCT TABLET;ORAL hydrochlorothiazide; valsartan 020818 2007-02-07
DIOVAN HCT TABLET;ORAL hydrochlorothiazide; valsartan 020818 2005-12-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 6, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 6, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;160MG
Approval Date:Jan 17, 2002TE:ABRLD:Yes

Expired US Patents for NDA 020818

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
AstraZeneca
Merck
Moodys
Boehringer Ingelheim

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 verification 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.