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Fish and Richardson
Chubb
UBS
US Army
Daiichi Sankyo
Medtronic
QuintilesIMS
Argus Health
McKinsey
Cantor Fitzgerald

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022314

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NDA 022314 describes EXFORGE HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. There are two 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 fifty 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 022314
Tradename:EXFORGE HCT
Applicant:Novartis
Ingredient:amlodipine besylate; hydrochlorothiazide; valsartan
Patents:2
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 N 0078-0559-30
EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314 NDA Novartis Pharmaceuticals Corporation 0078-0559 N 0078-0559-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 16, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;25MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022314

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-003 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-002 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-005 Apr 30, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Colorcon
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Federal Trade Commission
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