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ENTRESTO Drug Profile

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When do Entresto patents expire, and when can generic versions of Entresto launch?

Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this drug.

This drug has ninety patent family members in thirty-seven countries.

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 ENTRESTO

International Patents:	90
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	16
Clinical Trials:	22
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ENTRESTO
Prior Art and Litigation Support	Order Prior Art and Litigation support for ENTRESTO
DailyMed Link:	ENTRESTO at DailyMed

Generic Entry Opportunity Date for ENTRESTO

NDA:

207620

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 ENTRESTO

Drug Class	Neprilysin Inhibitor Angiotensin 2 Receptor Blocker
Mechanism of Action	Neprilysin Inhibitors Angiotensin 2 Receptor Antagonists

Synonyms for ENTRESTO

3-(1-Biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate

9052AF

AC-29037

ACN-036829

AK198922

AKOS026670199

C96H120N12Na6O21

D10226

Entresto (TN)

FT-0700025

LCZ 696

MolPort-042-624-138

Sacubitril mixture with valsartan

Sacubitril valsartan sodium hydrate (JAN)

UNII-WB8FT61183

Valsartan mixture with AHU-377

WB8FT61183

US Patents and Regulatory Information for ENTRESTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No			Y

International Patents for ENTRESTO

Country	Patent Number	Estimated Expiration
Japan	2015098485
Taiwan	201402111
Slovenia	1467728
South Korea	20040078127

Supplementary Protection Certificates for ENTRESTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	CA 2016 00023	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
1467728	16C0019	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1467728	CA 2016 00022	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
1467728	1690021-9	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123