Orange Book product · Brand (NDA)

ENTRESTO

SACUBITRIL; VALSARTAN

Brand (NDA)NDA 207620TE ABRX NOVARTIS PHARMS CORP

Jul 07, 2015

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 07, 2015
11 yr 1 mo ago
Today
Patent 9388134 expires
Listed method-of-use patent (U-1723) expiration.
Nov 08, 2026
in 5 mo
Patent 9388134*PED expires
Listed listed patent expiration.
May 08, 2027
in 11 mo
Patent 8877938 expires
Listed drug substance patent expiration.
May 27, 2027
in 11 mo
Patent 8877938*PED expires
Listed listed patent expiration.
Nov 27, 2027
in 1 yr 6 mo
Patent 11135192 expires
Listed method-of-use patent (U-3084) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9517226 expires
Listed method-of-use patent (U-3084) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 9937143 expires
Listed method-of-use patent (U-3084) expiration.
Aug 22, 2033
in 7 yr 3 mo
Patent 11058667 expires
Listed method-of-use patent (U-3170) expiration.
May 09, 2036
in 10 yr

Active ingredient

SACUBITRIL; VALSARTAN

Strength

24MG;26MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 207620

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9388134	Nov 08, 2026	in 5 mo	U-1723
9388134*PED	May 08, 2027	in 11 mo
8877938	May 27, 2027	in 11 mo	SubstanceProduct
8877938*PED	Nov 27, 2027	in 1 yr 6 mo
11135192	Aug 22, 2033	in 7 yr 3 mo	U-3084
9517226	Aug 22, 2033	in 7 yr 3 mo	U-3084
9937143	Aug 22, 2033	in 7 yr 3 mo	U-3084
11058667	May 09, 2036	in 10 yr	U-3170