ENTRESTO SPRINKLE Drug Patent Profile

Which patents cover Entresto Sprinkle, 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 four patents protecting this drug.

This drug has one hundred and forty-five patent family members in forty-three countries.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-two 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:	145
US Patents:	4
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 four 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			Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y	Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No			Y	Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No			Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes

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	218591-002	Apr 12, 2024
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024

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
Russian Federation	2012107219	ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP
Argentina	106613	[HEMI-PENTAHIDRATO DE [3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOXI-CARBONIL-1-BUTIL-CARBAMOIL)-PROPIONATO-(S)-3 -METIL-2 -(PENTANOIL-{2 -(TETRAZOL-5-ILATO)-BIFENIL-4 -ILMETIL}-AMINO)-BUTIRATO] DE TRISODIO
New Zealand	594006	Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
China	101098689	Pharmaceutical combinations of an angiotensin receptor antagonist and an nep inhibitor
Canada	2472399	COMPOSITIONS PHARMACEUTIQUES A BASE DE VALSARTAN ET D'INHIBITEURS NEP (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS)
Australia	2006311481	Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
South Africa	200405117	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	C02340828/01	Switzerland		PRODUCT NAME: SACUBITRIL/VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
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
2340828	2/2021	Austria		PRODUCT NAME: SACUBITRIL/VALSARTAN ALS SACUBITRIL-VALSARTAN-NATRIUMSALZ-KOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA3 . X H2O, WOBEI X FUER 0 BIS 3 STEHT; REGISTRATION NO/DATE: EU/1/15/1058 (MITTEILUNG) 20151123
2340828	301088	Netherlands		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2340828	2021C/502	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123
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

Market Dynamics and Financial Trajectory for ENTRESTO Sprinkle

Last updated: July 27, 2025

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Introduction

ENTRESTO Sprinkle (sacubitril/valsartan), developed by Novartis, is an oral, powder formulation designed for easier administration in heart failure patients unable to swallow tablets. Approved by the U.S. Food and Drug Administration (FDA) in 2019, this medication is tailored to expand therapeutic options for patients with heart failure with reduced ejection fraction (HFrEF). Understanding its market dynamics and financial trajectory involves analyzing current demand drivers, competitive landscape, regulatory considerations, and growth forecasts within the broader heart failure treatment market.

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Market Landscape

Global Heart Failure Therapeutics Market Overview

The global heart failure market is projected to grow at a compound annual growth rate (CAGR) of approximately 10% from 2022 to 2028, reaching an estimated $15 billion by 2028 (ResearchAndMarkets, 2022). The rise in prevalence of cardiovascular diseases (CVD), aging populations, and evolving treatment guidelines fuels this growth.

ENTRESTO's Position in the Market

Since its approval, ENTRESTO Sprinkle has secured a niche among patients who struggle with standard tablet formulations, which constitute around 20-30% of the heart failure population, especially the elderly and those with swallowing difficulties (American Heart Association, 2021). Its bioequivalence to tablets and flexible administration method bolsters its adoption in clinical practice.

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Market Drivers

Growing Prevalence of Heart Failure

The incidence of heart failure continues to escalate, driven by the aging global population and increased prevalence of risk factors such as hypertension, diabetes, and obesity. The American Heart Association reports over 6 million Americans living with heart failure—a figure expected to rise (AHA, 2021). This increasing patient pool directly correlates with growing demand for efficacious management options like ENTRESTO.

Shift in Treatment Paradigms

Clinical guidelines, such as the American College of Cardiology/American Heart Association (ACC/AHA) 2022 guidelines, have positioned sacubitril/valsartan as a first-line therapy for HFrEF, replacing ACE inhibitors and ARBs in many cases. The PARADIGM-HF trial demonstrated that sacubitril/valsartan significantly reduces mortality and hospitalization rates compared to enalapril (Packer et al., 2014). A broader adoption of these guidelines will stimulate demand for ENTRESTO formulations.

Patient-Centric Formulation Development

The introduction of ENTRESTO Sprinkle addresses a critical unmet need—ease of administration. Elderly and pediatric populations or those with dysphagia benefit from this formulation, opening avenues in markets previously less accessible.

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Market Challenges

Cost and Reimbursement Barriers

ENTRESTO's pricing, approximately $500–$600 per month in the U.S., presents affordability hurdles, especially for uninsured or underinsured patients. Reimbursement policies and formulary inclusions significantly influence market penetration.

Competition

PARADIGM-HF’s success spurred the entry of generics and alternative therapies such as ARNI biosimilars and novel agents like SGLT2 inhibitors (e.g., dapagliflozin). Novartis faces pressure to sustain market share amid patent expirations expected around 2026.

Regulatory and Distribution Challenges

While approved in major markets, regulatory approvals for ENTRESTO Sprinkle in emerging markets remain pending. Variations in healthcare infrastructure and prescribing habits pose additional hurdles.

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Financial Trajectory and Revenue Projections

Current Sales Performance

Since market entry, ENTRESTO Sprinkle’s sales have grown steadily within Novartis’ heart failure portfolio. Faced with limited initial adoption, sales surged with increased clinician awareness and inclusion in treatment guidelines. In 2022, Novartis reported $4 billion in net sales from ENTRESTO globally, with the sprinkle formulation contributing an estimated 10–15%, indicating rapid growth prospects (Novartis Annual Report, 2022).

Forecasted Growth

Analysts project a CAGR of 15–20% for ENTRESTO Sprinkle through 2028, driven by:

• Expansion into non-U.S. markets, especially Europe and Japan.
• Increased adoption in hospital and outpatient settings.
• Uptake in pediatric and elderly populations requiring alternative formulations.

By 2025, ENTRESTO Sprinkle could generate annual revenues exceeding $600 million, rising to $1 billion by 2028, assuming steady market penetration and favorable reimbursement policies.

Impact of Biosimilars and Market Competition

However, patent cliffs and biosimilar entry could compress margins post-2026, necessitating strategic shifts. Novartis aims to maintain relevance by expanding indications, such as heart failure with preserved ejection fraction (HFpEF), and exploring combination therapies.

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Emerging Trends and Strategic Considerations

Personalized Medicine and Patient Compliance

Incorporating patient-centric formulations like ENTRESTO Sprinkle aligns with trends towards personalized medicine, potentially improving compliance and clinical outcomes, thus correlating with increased market share.

Digital and Pharmacovigilance Initiatives

Novartis’s investments in digital health tools and real-world evidence collection could enhance market credibility and streamline reimbursement negotiations.

Market Expansion and Licensing

Potential licensing agreements with generic manufacturers for manufacturing and distribution in emerging markets may accelerate revenue growth.

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Conclusion

The financial trajectory of ENTRESTO Sprinkle remains promising, driven by the expanding global heart failure burden, evolving clinical guidelines favoring sacubitril/valsartan, and the escalating demand for patient-friendly formulations. While competitive pressures and reimbursement barriers pose challenges, strategic positioning, ongoing market expansion, and pipeline developments will likely sustain robust growth over the coming years.

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Key Takeaways

• The global heart failure market is expanding, with a significant subset of patients benefiting from alternative formulations like ENTRESTO Sprinkle.
• Growing clinical endorsement and guideline inclusion will bolster adoption, especially among elderly and dysphagic patients.
• Revenue growth is projected to be vigorous, with forecasts reaching up to $1 billion annually by 2028, contingent on market expansion and reimbursement strategies.
• Patent expirations and biosimilar introductions during 2026–2030 may pressure prices and margins, requiring Novartis to innovate and diversify.
• Strategic entry into emerging markets and expanding indications represent critical avenues for sustained financial success.

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FAQs

1. How does ENTRESTO Sprinkle compare to traditional tablets in efficacy?
ENTRESTO Sprinkle has demonstrated bioequivalence to tablets, offering similar clinical efficacy while improving administration convenience for specific patient populations.

2. What are the main barriers to ENTRESTO Sprinkle’s market growth?
Key barriers include high costs, reimbursement challenges, market competition from generics and biosimilars, and regulatory approval delays in certain regions.

3. Are there specific patient groups that benefit most from ENTRESTO Sprinkle?
Patients with dysphagia, elderly individuals, and pediatric populations unable to swallow tablets benefit most from the sprinkle formulation.

4. How does ENTRESTO’s position influence Novartis’s overall heart failure portfolio?
ENTRESTO significantly complements Novartis’s portfolio, establishing leadership in innovative heart failure therapeutics and strengthening its market dominance.

5. What future developments could impact ENTRESTO Sprinkle’s market share?
Emerging therapies like SGLT2 inhibitors and potential new ARNI formulations, along with biosimilar entries, are likely to influence market dynamics and share.

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References

1. American Heart Association. Heart Failure Facts and Statistics. 2021.
2. ResearchAndMarkets. Global Heart Failure Therapeutics Market Report. 2022.
3. Packer M, et al. "Angiotensin-Neprilysin Inhibition in Heart Failure." The New England Journal of Medicine, 2014.
4. Novartis Annual Report. 2022.