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Last Updated: March 2, 2021

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 one supplier. 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. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 022314
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 0078-0560 0078-0560-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0560-15)
Paragraph IV (Patent) Challenges for 022314
Tradename Dosage Ingredient NDA Submissiondate
EXFORGE HCT TABLET;ORAL amlodipine besylate; hydrochlorothiazide; valsartan 022314 2009-10-22
EXFORGE HCT TABLET;ORAL amlodipine besylate; hydrochlorothiazide; valsartan 022314 2009-09-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;12.5MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 16, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;25MG;160MG
Approval Date:Apr 30, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent 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 022314-005 Apr 30, 2009   Start Trial   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-001 Apr 30, 2009   Start Trial   Start Trial
Novartis EXFORGE HCT amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 022314-004 Apr 30, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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