Orange Book product · Brand (NDA)

ENTRESTO SPRINKLE

SACUBITRIL; VALSARTAN

Brand (NDA)NDA 218591RX NOVARTIS

Apr 12, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 12, 2024
2 yr 3 mo ago
Today
Patent 9388134 expires
Listed method-of-use patent (U-1723) expiration.
Nov 08, 2026
in 5 mo
Patent 8877938 expires
Listed drug substance patent expiration.
May 27, 2027
in 11 mo
Patent 10722471 expires
Listed drug product patent expiration.
Feb 02, 2037
in 10 yr 9 mo

Active ingredient

SACUBITRIL; VALSARTAN

Strength

15MG;16MG

Dosage form

CAPSULE, PELLETS

Route

ORAL

TE code

Not listed

Application

NDA 218591

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
8877938	May 27, 2027	in 11 mo	SubstanceProduct
10722471	Feb 02, 2037	in 10 yr 9 mo	ProductU-3896