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Last Updated: May 25, 2020

DrugPatentWatch Database Preview

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 is included in one NDA. It is available from one supplier. There are six 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. One supplier is 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:6
Generic Entry Opportunity Date for 207620
Generic Entry Date for 207620*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0078-0659-35 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0659-35) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0659-61)
Paragraph IV (Patent) Challenges for 207620
Tradename Dosage Ingredient NDA Submissiondate
ENTRESTO TABLET;ORAL sacubitril; valsartan 207620 2019-07-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength24MG;26MG
Approval Date:Jul 7, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 7, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 1, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 1, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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