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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 207620


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NDA 207620 describes ENTRESTO, which is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the ENTRESTO profile page.

The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 207620
Tradename:ENTRESTO
Applicant:Novartis Pharms Corp
Ingredient:sacubitril; valsartan
Patents:8
Pharmacology for NDA: 207620
Suppliers and Packaging for NDA: 207620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTRESTO sacubitril; valsartan TABLET;ORAL 207620 NDA Novartis Pharmaceuticals Corporation 0078-0659 0078-0659-20 60 TABLET, FILM COATED in 1 BOTTLE (0078-0659-20)
ENTRESTO sacubitril; valsartan TABLET;ORAL 207620 NDA Novartis Pharmaceuticals Corporation 0078-0659 0078-0659-67 180 TABLET, FILM COATED in 1 BOTTLE (0078-0659-67)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength24MG;26MG
Approval Date:Jul 7, 2015TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 16, 2024
Regulatory Exclusivity Use:LABELING REVISIONS RELATED TO CLINICAL STUDIES
Patent:⤷  Sign UpPatent Expiration:May 9, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
Patent:⤷  Sign UpPatent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

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