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Generated: June 25, 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. Ten 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

Ingredient-type	Dihydropyridines Thiazides
Mechanism of Action	Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

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	0078-0559-15
EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314	NDA	Novartis Pharmaceuticals Corporation	0078-0559	N	0078-0559-30

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG;12.5MG;160MG
Approval Date:	Apr 30, 2009	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	May 16, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Nov 16, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG;25MG;160MG
Approval Date:	Apr 30, 2009	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	May 16, 2023	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022314

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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	022314-002	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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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.