.

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): 022314

« Back to Dashboard
NDA 022314 describes EXFORGE HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the EXFORGE HCT profile page.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for NDA: 022314

Tradename:
EXFORGE HCT
Applicant:
Novartis
Ingredient:
amlodipine besylate; hydrochlorothiazide; valsartan
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022314

Suppliers and Packaging for NDA: 022314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL 022314 NDA Novartis Pharmaceuticals Corporation 0078-0559 0078-0559-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0559-15)
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL 022314 NDA Novartis Pharmaceuticals Corporation 0078-0559 0078-0559-30 30 BLISTER PACK in 1 CARTON (0078-0559-30) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:No
Patent:6,294,197*PEDPatent Expiration:Dec 18, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:8,101,599Patent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,475,839*PEDPatent Expiration:Nov 16, 2023Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022314

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 20095,399,578*PED► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 20095,399,578*PED► subscribe
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 20095,399,578*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