.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020818

« 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 nine suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the DIOVAN HCT profile page.

The generic ingredient in DIOVAN HCT is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 020818

Tradename:
DIOVAN HCT
Applicant:
Novartis
Ingredient:
hydrochlorothiazide; valsartan
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020818

Ingredient-typeThiazides
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 0078-0315-15 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0315-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0315-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 6, 1998TE:ABRLD:No
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 6, 1998TE:ABRLD:No
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;160MG
Approval Date:Jan 17, 2002TE:ABRLD:No
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020818

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-001Mar 6, 19985,399,578*PED► subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-003Jan 17, 20025,399,578*PED► subscribe
Novartis
DIOVAN HCT
hydrochlorothiazide; valsartan
TABLET;ORAL020818-005Apr 28, 20065,399,578*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.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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