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 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTRESTO SPRINKLE

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

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
Australia	2006311481	Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
Russian Federation	2018130601	ГАЛЕНОВЫЕ КОМПОЗИЦИИ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ
Singapore	10201402055Y	PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
Peru	20070803	COMBINACION FARMACEUTICA DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA
Spain	2290429
Australia	2019280026

Supplementary Protection Certificates for ENTRESTO SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1467728	300811	Netherlands		PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
2340828	C02340828/01	Switzerland		PRODUCT NAME: SACUBITRIL/VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
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	SPC/GB16/025	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/1058(NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2340828	C202130003	Spain		PRODUCT NAME: SACUBITRILO/VALSARTAN, COMO COMPLEJO SALINO DE SACUBITRILO, VALSARTAN Y SODIO, ES DECIR (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINA) / ESTER ETILICO DEL ACIDO ((2R,4S)-5-BIFENIL-4-IL-4-(3-CARBOXI-PROPIONIL AMINO)-2-METIL-PENTANOICO)) NA3 - X H2O, EN EL QUE X ES 0 A 3; NATIONAL AUTHORISATION NUMBER: EU/1/15/1058; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1058; DATE OF FIRST AUTHORISATION IN EEA: 20151119

ENTRESTO SPRINKLE: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

ENTRESTO SPRINKLE (sacubitril/valsartan), developed by Novartis, is an oral, powder-based formulation of the heart failure medication ENTRESTO designed for patients with swallowing difficulties. Marketed under the brand name Entresto, the SPRINKLE formulation addresses a niche within the heart failure therapeutic segment, reflecting both growth opportunities and competitive challenges. This analysis examines the investment landscape, market dynamics, and projected financial trajectory based on current trends, regulatory pathways, and competitive pressures.

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1. Market Overview

1.1. Global Heart Failure Market Size and Growth

Year	Market Size (USD Billion)	CAGR (2019-2027)	Key Drivers
2019	4.2	—	Rising prevalence, aging population
2022	6.1	~12%	Increased diagnosis, improved management
2027 (projected)	9.2	~13%	Expanding indications, novel therapies

Source: MarketWatch (2023) [1]

1.2. ENTRESTO Market Penetration

• 2015: FDA approval for HFrEF (Heart Failure with Reduced Ejection Fraction).
• 2022: Estimated global sales surpass USD 3.5 billion.
• Forecast: Market expected to reach USD 8 billion in 2027, driven by increased adoption.

1.3. Niche for ENTRESTO SPRINKLE

• Targeted at patients with dysphagia, elderly, or those unable to swallow pills.
• Estimated market share within ENTRESTO's total sales: 10-15% (~USD 350–525 million in 2022).
• Expected to grow as awareness increases and formularies adopt the formulation.

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2. Investment Scenario

2.1. Development and Regulatory Pathway

Development Milestones:

• Initial Approval: FDA (April 2019), EMA (October 2020).
• Formulation Specifics: Designed for ease of administration; bioequivalent to original ENTRESTO.

Regulatory Considerations:

• FDA Approval: Based on bioequivalence and safety demonstration.
• Orphan Designation: Not designated as orphan drug; primarily addressing a clinical need.
• Reimbursement Dynamics: Favorable coverage possible given the unmet need for patients with swallowing difficulties.

2.2. Commercialization Strategies

Strategy	Description	Expected Impact
Education & Awareness	Engage cardiologists, primary care physicians	Accelerate adoption
Formulary Inclusion	Seek inclusion in leading healthcare plans	Expand market access
Partnerships	Collaborate with healthcare providers	Facilitate patient access

2.3. Investment Risks

Risk Factor	Description	Mitigation Strategies
Competitive Products	Other formulations or drugs for dysphagic patients	Emphasis on clinical differentiation
Reimbursement Challenges	Payer hesitancy	Demonstrate cost-effectiveness
Market Penetration	Limited awareness among physicians	Aggressive education campaigns

2.4. Market Entry Cost Estimates

Cost Components	Approximate USD Millions	Notes
Clinical Trials	50–80	Primarily bioequivalence studies
Regulatory Filing	10–20	Submission, agency fees
Commercial Launch	30–60	Marketing, educational outreach
Total Estimated Investment	USD 90–160 million	Assuming successful pathway

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3. Market Dynamics

3.1. Competitive Landscape

Competitors	Key Attributes	Market Share	Notes
Standard ENTRESTO	Oral pill	~85%	Dominant in the market
Other formulations	Liquid, soluble tablets	10%	Niche segments
Pending competitors	Novel delivery systems	5%	Potential disruptors

Key Competitors for ENTRESTO SPRINKLE:

• Brand differentiation: Limited to dysphac patients.
• Patent Status: No direct competition with equivalent formulations; patent protection valid till at least 2030.

3.2. Pricing and Reimbursement Policies

Pricing Strategy	Details	Implication
Premium Pricing	For specialized formulation	Margins potentially higher but requires value demonstration
Reimbursement Code	New CPT/HCPCS codes needed for coverage	Streamline payer approvals

3.3. Regulatory and Policy Environment

• Increasing policies favoring formulations that improve patient adherence.
• Managed care organizations more receptive to cost-effective formulations.
• Potential incentives for innovations targeting elderly/disabled populations.

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4. Financial Trajectory

Year	Estimated Global Sales (USD Million)	Growth Rate	Notes
2022	350–525	—	Baseline for niche formulation
2023	450–600	25–15%	Initial uptake, increased prescriber awareness
2024	600–850	33–42%	Wider adoption, formulary inclusion
2025	900–1,200	33–41%	Denser market penetration
2026	1,300–1,700	44–42%	Market expansion, public health initiatives
2027	1,700–2,200	31–29%	Sustained growth, competitive positioning

Assumptions:

• Adoption rates increase with awareness.
• Reimbursement policies remain favorable.
• No unforeseen regulatory delays.

Key Factors Influencing Trajectory:

• Physician adoption rate.
• Patient compliance.
• Payer coverage expansion.
• Competitive entrants.

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5. Comparative Analysis

Aspect	ENTRESTO (Pill)	ENTRESTO SPRINKLE	Key Differences & Considerations
Formulation Type	Oral tablet	Powder for sprinkling	Patient compliance in dysphagia cases
Market Size	Large	Niche	Growth potential in specialized populations
Pricing	Premium	Similar/premium	Value-based pricing justified
Reimbursement	Widely covered	Conditional, based on indications	Policies evolving for specialized formulations
Competitive Threat	Few	Low – mainly internal formulations	First-mover advantage for SPRINKLE

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6. Strategic Recommendations

• Prioritize Education: Collaborate with cardiologists and primary care units to inform about benefits.
• Expand Market Access: Seek formulary placements and reimbursement approvals across regions.
• Invest in Data Generation: Conduct real-world evidence studies validating adherence and outcomes.
• Monitor Competitive Innovations: Stay alert to emerging delivery systems targeting similar patient populations.
• Leverage Policy Trends: Align with healthcare initiatives promoting patient-centric formulations.

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7. Key Takeaways

• ENTRESTO SPRINKLE addresses a proven unmet need among heart failure patients with swallowing difficulties.
• The market is expected to grow at a CAGR of approximately 13-15% through 2027, driven by increasing heart failure prevalence.
• Investment in formulation development, regulatory approval, and market access infrastructure requires an estimated USD 90–160 million.
• The key drivers for long-term success include physician advocacy, payer reimbursement policies, and differentiated clinical benefits.
• Competitive advantage hinges on early adoption, real-world evidence, and strategic partnerships.

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8. FAQs

Q1: What is the main clinical advantage of ENTRESTO SPRINKLE?

A: It provides an alternative, patient-friendly formulation for those with difficulty swallowing, ensuring consistent medication adherence and therapeutic efficacy.

Q2: How does the regulatory pathway differ for ENTRESTO SPRINKLE?

A: It primarily follows a bioequivalence pathway, with FDA and EMA requiring data demonstrating pharmacokinetic similarity and safety to the original ENTRESTO pill.

Q3: What are the main barriers to market penetration?

A: Limited physician awareness initially, reimbursement challenges, and higher formulation costs may slow uptake, especially in regions with conservative formulary policies.

Q4: How can companies mitigate competitive threats?

A: By generating robust real-world evidence, fostering early payer engagement, and expanding indications targeting specific patient populations.

Q5: What is the total addressable market for ENTRESTO SPRINKLE?

A: Approximately USD 350–525 million globally in 2022, with potential to expand as awareness and indications grow.

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References

[1] MarketWatch. "Heart Failure Drugs Market Size & Trends," 2023.
[2] Novartis Annual Report 2022.
[3] FDA & EMA Labeling information, 2019–2022.
[4] IQVIA Data on Heart Failure Trends, 2022.

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