ENTRESTO SPRINKLE Drug Patent Profile

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

Entresto Sprinkle is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-nine countries.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Entresto Sprinkle

A generic version of ENTRESTO SPRINKLE was approved as sacubitril; valsartan by ALEMBIC on May 28^th, 2024.

Summary for ENTRESTO SPRINKLE

International Patents:	108
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ENTRESTO SPRINKLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTRESTO SPRINKLE
DailyMed Link:	ENTRESTO SPRINKLE at DailyMed

See drug prices for ENTRESTO SPRINKLE

Pharmacology for ENTRESTO SPRINKLE

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

US Patents and Regulatory Information for ENTRESTO SPRINKLE

ENTRESTO SPRINKLE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No	10,722,471		Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes	10,722,471		Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No	9,388,134
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No	8,877,938		Y	Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes	8,877,938		Y	Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes	9,388,134

Expired US Patents for ENTRESTO SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024	8,101,659
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024	8,101,659

EU/EMA Drug Approvals for ENTRESTO SPRINKLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Neparvis	sacubitril, valsartan	EMEA/H/C/004343Paediatric heart failureNeparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1).Adult heart failureNeparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).	Authorised	no	no	no	2016-05-26
Novartis Europharm Limited	Entresto	sacubitril, valsartan	EMEA/H/C/004062Paediatric heart failureEntresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.Adult heart failureEntresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.	Authorised	no	no	no	2015-11-19

International Patents for ENTRESTO SPRINKLE

When does loss-of-exclusivity occur for ENTRESTO SPRINKLE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

Croatia

Cyprus

Denmark

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Korea

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ENTRESTO SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2019504094	有機化合物のガレヌス製剤
China	102702119	Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
European Patent Office	1467728	COMPOSITIONS PHARMACEUTIQUES A BASE DE VALSARTAN ET D'INHIBITEURS NEP (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS)
Canada	2590511	COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Cyprus	1123531
Canada	2472399	COMPOSITIONS PHARMACEUTIQUES A BASE DE VALSARTAN ET D'INHIBITEURS NEP (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS)

Supplementary Protection Certificates for ENTRESTO SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	PA2021502	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	340 5007-2016	Slovakia		PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2340828	PA2021502,C2340828	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3 - X H2O, KUR X YRA 0 - 3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1948158	PA2016017	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828	C20210001 00430	Estonia		PRODUCT NAME: SAKUBITRIIL/VALSARTAAN;REG NO/DATE: EU/1/15/1058 23.11.2015
2340828	21C1000	France		PRODUCT NAME: SACUBITRIL/VALSARTAN, SOUS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE.; REGISTRATION NO/DATE: EU/1/15/1058 20151123

Market Dynamics and Financial Trajectory for ENTRESTO SPRINKLE

Last updated: February 19, 2026

What is ENTRESTO SPRINKLE?

ENTRESTO SPRINKLE is an oral powder formulation of sacubitril/valsartan, marketed under the brand name ENTRESTO. Approved by the FDA in 2021, it targets heart failure with reduced ejection fraction (HFrEF). The drug is designed for patients who have difficulty swallowing tablets, offering an alternative delivery format.

Market Size and Adoption

ENTRESTO's global sales reached approximately $583 million in 2022, according to IQVIA. The market segment primarily includes patients with HFrEF aged over 18, a group estimated at 26 million worldwide. The drug’s adoption is influenced by heart failure prevalence, insurance coverage, and clinical guidelines.

Heart Failure Market Overview

Metric	Data	Source
Global HFrEF prevalence	26 million (2020)	[1]
Annual growth rate	2.3%	[2]
Estimated treatment rate	20-25%	[3]

The high prevalence of HFrEF and the shift toward more aggressive management strategies support continued sales growth. The introduction of an alternative formulation like SPRINKLE caters to a subset of patients with swallowing difficulties, expanding market accessibility.

Competitive Landscape

The primary competitors include:

• BiDil (isosorbide dinitrate/hydralazine): Approved for heart failure in specific populations.
• Corlanor (ivabradine): Used alongside standard therapy for certain HFrEF patients.
• Traditional sacubitril/valsartan tablets: The initial formulation dominates sales.

ENTRESTO SPRINKLE competes indirectly with these treatments, with its unique value proposition centered on ease of administration.

Key Differentiators

• Ease of use for patients who cannot swallow tablets.
• Similar efficacy to tablets based on clinical trials.
• Slightly higher cost due to formulation complexity.

Regulatory and Reimbursement Landscape

The drug gained FDA approval in March 2021, with European regulatory approval following in late 2021. Reimbursement policies vary by country, with the US market primarily managed through Medicare and private insurers.

In the US, the average wholesale price (AWP) for ENTRESTO SPRINKLE is approximately US$600 per month, comparable to tablets but with a higher cost due to formulation process. The coverage rate is estimated at 85%, though out-of-pocket costs may influence patient uptake.

Revenue Trajectory and Growth Drivers

Short-term Outlook (2023-2025)

• Projected sales increase at a CAGR of 12-15%, driven by increased adoption in the US and Europe.
• Expansion into new markets, including Japan and Canada, expected by 2024.
• Key factors: physician awareness campaigns, inclusion in clinical guidelines, and reimbursement adjustments.

Long-term Outlook (2026-2030)

• Sales estimated to reach $1.2 billion by 2030 under optimistic assumptions.

• Market penetration will depend on:

  • Competitive dynamics among formulations.
  • Advances in heart failure management.
  • Ongoing real-world evidence supporting efficacy and safety.

Risks and Challenges

• Market saturation in developed regions.
• Price pressure from generics or biosimilars.
• Slow adoption among some clinicians due to familiarity with existing therapies.
• Pending patent expirations, possibly affecting pricing power.

Patent and Market Exclusivity

ENTRESTO's original patent expires in 2030 in the US, with patent extensions possible based on formulations. Market entry of generics typically follows patent expiration, potentially impacting revenue streams.

Key Takeaways

• ENTRESTO SPRINKLE addresses a niche for patients with swallowing difficulties, broadening the overall market for sacubitril/valsartan.
• The drug's sales are expected to grow steadily over the next five years, supported by increasing heart failure prevalence and expanded reimbursement.
• Competition remains primarily from tablet formulations and other heart failure therapies, with pricing pressures anticipated as patent protections lapse.
• Regional market access and physician awareness are critical to maximizing long-term revenue.

FAQs

1. How does ENTRESTO SPRINKLE compare to the tablet form in efficacy?
   Clinical trials show similar efficacy between the SPRINKLE formulation and tablets in reducing heart failure symptoms and hospitalizations.

2. What patient populations primarily use ENTRESTO SPRINKLE?
   Patients with difficulty swallowing tablets, including elderly and neurodegenerative disease sufferers.

3. What are the main barriers to market growth?
   Higher formulation cost, clinician familiarity with tablets, and reimbursement limitations.

4. Will generic versions impact ENTRESTO SPRINKLE sales?
   Potentially after patent expiry; market exclusivity is likely until 2030 in the US.

5. What are key strategies for expanding market share?
   Increasing physician education, expanding into new regions, and securing favorable reimbursement policies.

References

[1] Ponikowski, P., et al. (2020). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 37(27), 2129-2200.

[2] Roger, V. L., et al. (2019). Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation, 139(10), e56-e528.

[3] Heidenreich, P. A., et al. (2019). Forecasting the future of cardiovascular disease in the United States. Circulation: Cardiovascular Quality and Outcomes, 12(11), e005375.