Viewing data from:

ENTRESTO SPRINKLE

NDA

SACUBITRIL; VALSARTAN | N218591 | NOVARTIS PHARMACEUTICALS CORP

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (2)Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

8877938

May. 27, 2027

9388134

Nov. 8, 2026

10722471

Feb. 2, 2037

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

39 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans NCT03938389	Phase 4	Active	Ohio State University	90	2020-02-25 → 2026-06
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study NCT04191681	Phase 4	Recruiting	The Cleveland Clinic	50	2019-11-08 → 2022-12
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals NCT04055428	Phase 2	Recruiting	University of Alabama at Birmingham	200	2020-08-15 → 2027-05-31
The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction NCT03893435	N/A	Completed	The Young Investigator Group of Cardiovascular Research	192	2018-12-01 → 2022-10-01
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients NCT03300427	Phase 4	Completed	Novartis Pharmaceuticals	55	2018-07-05 → 2022-03-23
Prevention of Cardiac Dysfunction During Breast Cancer Therapy NCT03760588	Phase 2	Completed	Torbjorn Omland	138	2019-01-31 → 2024-09-05
A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients NCT03066804	Phase 3	Completed	Novartis Pharmaceuticals	2,572	2017-08-22 → 2019-10-28
Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study NCT02916160	Phase 4	Completed	University Hospital, Montpellier	124	2016-09-22 → 2020-02-27
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC NCT04023227	Phase 4	Completed	Novartis Pharmaceuticals	922	2019-12-10 → 2025-03-31
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis NCT02754518	Phase 4	Completed	University of Chicago	40	2016-04 → 2019-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$11.64

per ea

Lowest NADAC/Unit

$11.64

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078123820ENTRESTO SPRINKLE 15-16 MG PLT	$11.64	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$525.46

Highest Price

$694.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-1231-20ENTRESTO SPRINKLE 6MG/6MG CAP	$694.58	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-1231-20ENTRESTO SPRINKLE 6MG/6MG CAP	$533.13	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-1238-20ENTRESTO SPRINKLE 15MG/16MG CAP	$694.58	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-1238-20ENTRESTO SPRINKLE 15MG/16MG CAP	$525.46	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Entresto Sprinkle (2024)

Total Spending

$145K

Total Claims

173

Beneficiaries

Avg Cost/Unit

$11.25

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 1, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 6MG;6MG

RLD

3 patents0 exclusivities▴

CAPSULE, PELLETS;ORAL | Approved: Apr 12, 2024

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8877938	May 27, 2027	—	Yes	Yes	—	—
9388134	Nov 8, 2026	—	—	—		—
10722471	Feb 2, 2037	—	—	Yes		—

#002 — 15MG;16MG

RLD

3 patents0 exclusivities▾

CAPSULE, PELLETS;ORAL | Approved: Apr 12, 2024