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Chinese Patent Office
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021990

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NDA 021990 describes EXFORGE, which is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and six Paragraph IV challenges. Additional details are available on the EXFORGE profile page.

The generic ingredient in EXFORGE 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 021990
Tradename:EXFORGE
Applicant:Novartis
Ingredient:amlodipine besylate; valsartan
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021990
Suppliers and Packaging for NDA: 021990
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0488 N 0078-0488-15
EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0489 N 0078-0489-15

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 8, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 8, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Jun 20, 2007TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 8, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021990

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-005 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-003 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-002 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990-004 Jun 20, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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