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.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. Twenty-eight 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

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

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	2017215530
Australia	2019280026
Canada	3010778
China	108601741
Denmark	3411021

Supplementary Protection Certificates for ENTRESTO SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	PA2016017,C1948158	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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	1690020-1	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
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
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123

Last updated: July 12, 2026

ENTRESTO SPRINKLE investment scenario and fundamentals analysis (patent, FDA exclusivity, generics risk, and revenue outlook)

Executive summary: Entresto Sprinkle (sacubitril/valsartan) is the pediatric-friendly granule formulation of Novartis’s core heart failure blockbuster. The investment case hinges on: (1) how quickly pediatric demand scales, (2) whether patent and pediatric exclusivity layers stay intact through the next 7–10 years, and (3) whether alternative formulations or competitors erode share in HFrEF/HF outcomes markets. Near-term downside risk is concentrated in: Orange Book-connected composition/method-of-use IP, and generic entry pressure once key legal and exclusivity gates open. The upside path is concentrated in pediatric labeling expansion and treatment persistence in low-dose titration pathways where Sprinkle is most relevant.

Core fundamentals snapshot

• Drug: Entresto Sprinkle (sacubitril/valsartan) oral granules for pediatric use
• Originator: Novartis
• Therapeutic area: Chronic heart failure (HFrEF), and broader HF indications where sacubitril/valsartan is authorized
• Commercial lever: Pediatric dosing convenience, titration adherence, and guideline uptake in the pediatric HF segment
• Main investment drivers:
  • Pediatric launch curve and share penetration
  • Patent term and regulatory exclusivity durability for the specific Sprinkle presentation
  • Timing and intensity of ANDA/Para IV pressure for formulation and method-of-use claims
  • Competitive dynamics from other HF drug classes (notably ARNI alternatives and HF device-driven care patterns)

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What patents protect ENTRESTO SPRINKLE (sacubitril/valsartan) granules and what is the expiration risk

Featured snippet answer: Entresto Sprinkle is protected by the same sacubitril/valsartan IP “family” as Entresto plus presentation-specific protection tied to the granule formulation, dosing, and manufacturing. Expiration and generic risk follow the earliest expiring relevant claims for composition, granule/formulation process, and any method-of-use claims tied to pediatric dosing or HF indication.

How the patent estate typically breaks down for Sprinkle-type presentations

• Core API composition and salts: sacubitril/valsartan composition, and pharmaceutically acceptable forms
• Formulation patents: granule formulation parameters (particle size, excipient system, dissolution/disintegration behavior, stability)
• Manufacturing/process patents: granulation, drying, blending, and packaging stability specs
• Method-of-use patents: dosing regimens (including pediatric titration schedules), HF patient selection criteria, and use in specific disease states

Patent strength indicators investors track

• Claim coverage depth: multiple independent claims across composition, formulation, and manufacturing
• Family redundancy: overlapping continuations that maintain fallback positions
• Remaining life: earliest expiration date across claims mapped to the marketed Sprinkle product
• Litigation posture: whether any relevant patents have already been challenged and how courts ruled

Practical implication

If the Sprinkle presentation is only weakly distinguished from other oral solid forms of Entresto, generic entry can proceed on “non-infringing” composition paths after the earliest core claim expires. If Sprinkle has dedicated formulation claims with strong claim scope and strong testing benchmarks, ANDA-style workarounds become more expensive and slower.

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When does ENTRESTO SPRINKLE lose exclusivity and what timelines matter most

Featured snippet answer: Exclusivity loss risk is driven by (1) patent term for the earliest claim blocking generic approval and (2) regulatory exclusivities tied to pediatric indication and pediatric formulation. Practically, the gating events investors model are patent expiry plus any pediatric exclusivity extensions that apply to the specific approved product.

Exclusivity timeline model used in investment cases

• Step 1: Earliest blocking patent expiry
  • Investors identify the first claim-set that an ANDA would have to certify under Paragraph IV
• Step 2: FDA exclusivity overlay
  • Pediatric exclusivity (when applicable) can extend exclusivity beyond the baseline patent expiry for the qualified product/indication
• Step 3: Actual launch window
  • Even after theoretical expiry, generic timelines depend on litigation schedules, FDA review cycles, and final labeling negotiations

Decision-relevant milestones

• Filing-to-approval lead times for ANDAs
• Settlement triggers (typical in brand-generic frameworks)
• Pediatric label expansion approvals, which can shift demand and potentially extend commercial value even if older core exclusivity fades

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What Orange Book status does ENTRESTO SPRINKLE have and how many listed patents are Orange Book-listed

Featured snippet answer: Orange Book status for Entresto Sprinkle determines the practical blocking landscape for generics. Investors evaluate the number of listed patents and whether they are tied to the active ingredient, dosage form, or method of use.

What counts for investors

• Number of Orange Book patents: a higher count can increase work for generic filers but also increases legal surface area
• Patent types: drug substance vs drug product vs method-of-use patents
• Expiration dispersion: wide spread means investors get multiple “layers” of delay
• Missing link risk: if Sprinkle patents are not listed or are thin, generic entry can accelerate

Investment read-through

A brand with dense Orange Book coverage often sees more Paragraph IV litigation, more settlements, and fewer clean “at-risk” launch windows. Sparse coverage usually correlates with faster erosion once the earliest patent ends.

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How strong is the patent estate for ENTRESTO SPRINKLE versus other sacubitril/valsartan formulations

Featured snippet answer: Entresto Sprinkle’s strength depends on whether it has presentation-specific formulation and manufacturing patents that are enforceable against an ANDA product that can still meet basic bioequivalence.

Comparison framework

• Claim scope: whether claims cover ranges that are hard to replicate
• Testing benchmarks: stability, dissolution profiles, impurity limits, and granule behavior
• Excipients and processing: whether inventors tied protection to a narrow excipient matrix or broad formulation rules
• Regulatory leverage: whether pediatric use ties method-of-use claims to a specific pediatric dosing algorithm

Investment relevance

If competing oral solids (tablets/capsules or other granule formats) are covered by a weaker formulation shield, investors should model share shifts toward the protected presentation only to the extent pediatric prescribing favors that exact dosing format.

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What generic entry risks exist for ENTRESTO SPRINKLE (ANDA/Paragraph IV pathways)

Featured snippet answer: Generic entry risk is concentrated in ANDA Paragraph IV certifications against Orange Book-listed patents for (1) drug product/granules and (2) any enforceable method-of-use claims relevant to the approved pediatric indication.

Primary generic “at-risk” vectors

• Drug product formulation workarounds: change excipient system while maintaining bioequivalence
• Manufacturing process redesign: different granulation/drying steps to avoid process claim infringement
• Label carveouts: avoid infringing method-of-use language via labeling and REMS-style restrictions (where applicable)
• Stability-driven constraints: if stability or impurity profiles are part of protected parameters, generic development faces higher CMC burden

Timeline impact

If a generic filer must challenge multiple Orange Book patents to obtain approval, the expected entry date shifts from “earliest expiry” to “settlement or final judgment timing.”

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What patent litigation affects ENTRESTO SPRINKLE and how settlements change launch dates

Featured snippet answer: Litigation determines whether generics launch at first expiry, later after an injunction or settlement, or not at all for certain claims. For Sprinkle, litigation risk is most acute around presentation-specific patents and any method-of-use patents tied to pediatric dosing.

What investors model in litigation scenarios

• Paragraph IV count and venues: more patents usually means more consolidated filings and higher litigation leverage for the brand
• Court outcomes by claim type: composition/formulation process claims often face different infringement proof standards than method-of-use claims
• Settlement terms:
  • Date-based “launch-forcing” entry windows
  • Product-shape or formulation limitations
  • Carveouts from labeling

Commercial implication

Settlements often preserve brand cash flows longer than pure patent expiry models. For an investment scenario, the key is whether settlements target the earliest expiring claims tied to Sprinkle, not merely core sacubitril/valsartan.

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How does ENTRESTO SPRINKLE compare with Entresto tablets/capsules for pediatric adoption and payer dynamics

Featured snippet answer: Entresto Sprinkle is positioned for pediatric dosing convenience, titration, and adherence. Adoption depends on how quickly clinicians switch from alternative pediatric formulations or therapeutic substitutes, and whether payers treat Sprinkle as a preferred pediatric formulary option.

Commercial comparisons investors track

• Dosing flexibility: ability to administer via specific pediatric routes or feeding workflows
• Persistence: refill and duration on therapy in pediatric populations
• Titration throughput: ease of moving patients to target or tolerable doses
• Payer authorization friction: prior authorization and step edits
• Exclusions: whether formularies cover Sprinkle only after specific criteria

Market share interpretation

Even if Entresto is stable in adults, pediatric Sprinkle can be a growth or a lagging contributor depending on dosing guideline uptake and competitive substitution.

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What is the FDA regulatory status of ENTRESTO SPRINKLE and what labeling changes matter for investors

Featured snippet answer: Entresto Sprinkle’s FDA regulatory status determines exclusivity and the breadth of its labeled pediatric indications. Label expansions that broaden patient eligibility can extend commercial runway even if core exclusivity weakens.

Regulatory items to factor

• Approval date for pediatric granules: anchors product-specific exclusivity analysis
• Indication scope: HFrEF and other HF populations where sacubitril/valsartan is authorized
• Dose form constraints: how the label defines pediatric administration and titration

Investment relevance

Label breadth affects the market addressable volume. Narrow labeling makes share gains harder and increases risk that generic entry happens before pediatric scaling achieves return targets.

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Investment scenario: bull/base/bear cases for ENTRESTO SPRINKLE revenue contribution

Featured snippet answer: The bull case depends on pediatric dosing scale-out and durable formulation exclusivity; the bear case assumes earlier-than-modeled exclusivity pressure and payer-driven substitution to non-sprinkle forms or competing HF therapies.

Bull case (pediatric scaling + durable protection)

• Pediatric adoption accelerates as clinicians standardize on Sprinkle titration workflows
• Brand maintains premium positioning with minimal generic or “authorized generic” encroachment
• Patent and exclusivity layers delay Para IV entry beyond the investor base case

Base case (steady pediatric growth + manageable legal risk)

• Pediatric demand grows with normal adoption friction
• Legal milestones push generic entry to later windows, limiting near-term erosion
• Share remains stable, with growth offset by competitive HF category dynamics

Bear case (earlier pressure + formulation workarounds)

• Generic filers successfully design around formulation or manufacturing claims
• Label carveouts reduce incremental brand demand
• Pediatric uptake underperforms due to payer barriers, and brand faces faster erosion

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Key commercial KPIs for ENTRESTO SPRINKLE investors

• Pediatric patient starts per quarter
• Rx volume and persistence on therapy
• Share of pediatric ARNI-treated patients
• Net price and payer mix for pediatric claims
• Time-to-reimbursement and authorization approval rates
• Any generic “authorized” or branded-comps substitution signals

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Key Takeaways

• Entresto Sprinkle’s investment thesis is tied to pediatric scaling and the durability of granule-specific patent and exclusivity layers.
• Generic entry risk concentrates on Orange Book-listed formulation and method-of-use patents and the timing of Paragraph IV litigation and settlements.
• The most value-relevant milestones are the earliest blocking claim expirations and any pediatric exclusivity extensions tied to the approved Sprinkle product.
• Revenue upside is dominated by pediatric label penetration, persistence, and reduced payer friction. Revenue downside is dominated by earlier-than-expected legal clearance and formulation workarounds that enable timely ANDA approvals.

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FAQs

1. What patent claim types usually determine generic launch timing for sacubitril/valsartan granules?
2. How do pediatric exclusivity extensions interact with formulation-specific Orange Book listings?
3. What labeling carveouts most often reduce method-of-use infringement exposure for ANDAs?
4. When do settlements typically set the effective launch date relative to patent expiry for heart failure brands?
5. How should investors model payer restrictions for pediatric ARNI granules versus adult formulations?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and related labeling for Entresto (sacubitril/valsartan) and pediatric formulations. U.S. Food and Drug Administration.
3. FDA. Paragraph IV Certification and patent litigation framework (Hatch-Waxman). U.S. Food and Drug Administration.