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-seven 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

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
Australia	2017215530
Australia	2019280026
Canada	3010778
China	108601741

Supplementary Protection Certificates for ENTRESTO SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1467728	16C0019	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1467728	19/2016	Austria		PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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
1467728	93074	Luxembourg		PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123

ENTRESTO SPRINKLE Market Dynamics, Financial Trajectory, Patents and Generic Risk

Last updated: August 7, 2026

ENTRESTO SPRINKLE is a pediatric and swallowability-focused formulation of sacubitril/valsartan, Novartis’s flagship heart-failure product. Its commercial value is likely to come from lifecycle management rather than a standalone revenue stream. Novartis does not report ENTRESTO SPRINKLE sales separately, so the product’s financial trajectory must be assessed through total ENTRESTO revenue, pediatric market expansion, formulation protection and erosion risk from generic sacubitril/valsartan tablets.

What is ENTRESTO SPRINKLE and which patients does it target?

ENTRESTO SPRINKLE contains sacubitril and valsartan in oral-pellet form. The pellets are intended for patients who cannot swallow conventional tablets, including young children and some adults with swallowing difficulties.

The formulation is relevant to pediatric patients with heart failure and systemic left-ventricular systolic dysfunction. The FDA-approved product labeling covers pediatric patients from 1 year to less than 18 years of age, subject to the labeled indication and dosing requirements. The pellets are supplied in two strengths:

Strength	Sacubitril	Valsartan
Lower strength	6 mg	6 mg
Higher strength	15 mg	16 mg

The unequal valsartan milligram amounts reflect the active moiety relationship used in the sacubitril/valsartan combination. ENTRESTO SPRINKLE is administered by sprinkling the pellets on soft food rather than crushing or chewing them. The FDA labeling contains specific handling and administration instructions.[1]

How does ENTRESTO SPRINKLE compare with ENTRESTO tablets?

ENTRESTO tablets remain the principal formulation for adults and older children who can swallow solid dosage forms. ENTRESTO SPRINKLE addresses a narrower population but may improve initiation and persistence in pediatric and dysphagic patients.

Factor	ENTRESTO tablets	ENTRESTO SPRINKLE
Primary users	Adults and older children	Young children and patients unable to swallow tablets
Delivery format	Film-coated tablets	Oral pellets
Commercial role	Core product	Lifecycle-management extension
Prescribing base	Broad heart-failure population	Narrower pediatric and swallowing-limited population
Generic exposure	High as tablet patents expire	Potentially lower initially if formulation protection remains
Revenue disclosure	Included in ENTRESTO sales	Not separately disclosed

The product is not a new active pharmaceutical ingredient. Its commercial differentiation depends on dosage-form convenience, pediatric use, physician familiarity with ENTRESTO, and any formulation-specific regulatory or patent protection.

What is the FDA regulatory status of ENTRESTO SPRINKLE?

The FDA approved ENTRESTO SPRINKLE as an oral-pellet formulation of sacubitril/valsartan. The approval expanded the ENTRESTO dosage-form portfolio without changing the product’s underlying mechanism of action.

Sacubitril inhibits neprilysin after conversion to its active metabolite, while valsartan blocks the angiotensin II type 1 receptor. The combination is used in heart failure management and is supported by the broader ENTRESTO clinical and regulatory record.

The principal regulatory advantages are:

1. Pediatric dosing is incorporated into the approved labeling.
2. The product addresses an administration barrier that tablets do not fully solve.
3. The formulation supports continued use of the ENTRESTO brand as tablet exclusivity declines.
4. A pediatric formulation can create switching friction for caregivers and prescribers.

The FDA approval does not create a separate biologic exclusivity framework. ENTRESTO SPRINKLE is a small-molecule drug product, so biosimilar risk does not apply. Competitive exposure will come from generic sacubitril/valsartan products and potentially from alternative pediatric formulations.

How large is the ENTRESTO market?

ENTRESTO is one of Novartis’s largest commercial products. Novartis reported annual ENTRESTO sales of approximately $6 billion in 2023, with continued growth driven by heart-failure guideline adoption, broader use in patients with preserved or mildly reduced ejection fraction, and geographic expansion.[2]

ENTRESTO SPRINKLE represents only a subset of that market. Novartis does not provide a separately reported revenue line for the sprinkle formulation. Its direct revenue contribution is therefore likely to be modest relative to tablet sales, while its strategic value is greater than its initial sales contribution.

What drives ENTRESTO revenue growth?

The principal revenue drivers are:

• Continued conversion from ACE inhibitors and angiotensin receptor blockers.
• Broader use across heart-failure phenotypes.
• Hospital and specialist adoption.
• Increased diagnosis and treatment of chronic heart failure.
• Pediatric and dysphagia-focused lifecycle management.
• Geographic expansion outside the United States.
• Delayed generic entry in certain markets.

The largest risk to the financial trajectory is the loss of exclusivity for core sacubitril/valsartan products. ENTRESTO SPRINKLE can soften that impact in a narrowly defined population, but it is unlikely to offset broad generic erosion across adult tablet prescriptions.

When does ENTRESTO lose exclusivity?

ENTRESTO exclusivity is jurisdiction-specific and depends on the patent, regulatory exclusivity period, pediatric extensions and any litigation settlements. The principal U.S. product is exposed to generic competition as listed patents and related protections expire.

The relevant protection categories include:

Protection category	Commercial relevance
Active-ingredient combination patents	Protect sacubitril/valsartan use and composition
Formulation patents	May protect oral pellets, dosing architecture or excipients
Method-of-use patents	May cover selected heart-failure populations or treatment methods
Pediatric exclusivity	Can add six months to qualifying listed patents
Regulatory exclusivity	Depends on the specific FDA approval and statutory pathway
Settlement agreements	May establish an agreed generic launch date

The FDA Orange Book should be used as the controlling source for listed patents, expiration dates and any pediatric exclusivity notation. Patent dates can differ between the basic combination, specific dosage forms and methods of use.[3]

Does ENTRESTO SPRINKLE have separate patent protection?

A separate product-specific patent estate would be commercially important if it covers the oral-pellet formulation, manufacturing process or administration method. The existence, scope and enforceability of such protection must be assessed from the current Orange Book listings and the underlying patent family, rather than inferred from the brand approval alone.

A formulation patent could delay direct generic substitution for the sprinkle product even after tablet patents expire. It would not necessarily prevent generic tablets from entering the broader adult market.

What patent litigation and Paragraph IV risks affect ENTRESTO?

Generic sacubitril/valsartan applicants can challenge listed patents through an ANDA Paragraph IV certification. Such challenges typically allege that the patent is invalid, unenforceable or not infringed.

The risk profile has two layers:

Tablet-level generic risk

This is the larger financial exposure. Generic tablets can target the high-volume adult market and produce rapid price erosion after launch. A successful Paragraph IV challenge, a settlement with an authorized launch date, or patent expiration can materially reduce ENTRESTO revenue.

Sprinkle-level generic risk

The sprinkle formulation has a smaller addressable market but may have a different technical barrier. Generic applicants would need to match the active ingredients, strength, particle or pellet characteristics, release behavior, stability, labeling and administration method required for approval.

A generic tablet applicant does not automatically obtain approval for an oral-pellet product. Conversely, a formulation patent may not prevent a generic company from marketing tablets.

No biosimilar litigation is relevant because sacubitril/valsartan is a synthetic small-molecule combination, not a biologic.

Which companies are challenging ENTRESTO exclusivity?

Generic competition is expected from companies with established cardiovascular portfolios and ANDA capabilities. Potential competitors include large generic manufacturers and specialty companies that have filed or may file sacubitril/valsartan applications.

The competitive assessment should distinguish:

• Companies with approved or tentatively approved tablet ANDAs.
• Companies that have filed Paragraph IV certifications.
• Applicants covered by litigation stays.
• Companies subject to settlement-based launch restrictions.
• Applicants pursuing a sprinkle or other pediatric dosage form.

A company’s tablet challenge does not establish that it has a commercially viable ENTRESTO SPRINKLE substitute. Product-specific competition requires a separate formulation strategy and FDA approval.

What financial trajectory is likely for ENTRESTO SPRINKLE?

ENTRESTO SPRINKLE is likely to follow a three-stage commercial trajectory.

2024-2026: launch and targeted adoption

Initial sales should come from pediatric cardiology, hospital systems and patients unable to swallow tablets. Uptake will depend on formulary placement, caregiver convenience, pharmacy availability and whether the product carries a meaningful premium over tablets.

Revenue contribution is likely to remain small relative to total ENTRESTO sales. The principal near-term benefit is retention of patients within the Novartis franchise.

2026-2028: franchise defense and formulation substitution

As tablet generic competition develops, Novartis may use the sprinkle product to preserve branded treatment in pediatric and administration-sensitive segments. The product may also support contracting strategies with specialty pharmacies and pediatric centers.

The extent of revenue protection will depend on whether generic manufacturers can offer equivalent oral-pellet products and whether payers impose mandatory generic substitution.

After broad tablet generic entry: residual specialty revenue

Once generic sacubitril/valsartan tablets achieve meaningful share, total ENTRESTO revenue is likely to decline. ENTRESTO SPRINKLE could retain a higher proportion of branded share in patients who cannot use tablets, but the segment is too narrow to preserve the historical revenue base by itself.

A reasonable commercial model is therefore:

Period	ENTRESTO franchise outlook	ENTRESTO SPRINKLE role
Launch period	Continued growth or high stability	New pediatric and dysphagia revenue
Early generic period	Increasing price and volume pressure	Franchise retention in specialized users
Mature generic period	Material erosion	Residual premium formulation niche

How strong is the patent estate for ENTRESTO SPRINKLE?

The patent estate should be rated as strategically useful but commercially limited unless it includes enforceable formulation claims with a late expiration date.

Patent strength depends on:

• Whether claims cover the pellet structure rather than only broad excipient combinations.
• Whether the formulation solves a measurable stability, dosing or administration problem.
• Whether generic applicants can design around the claims.
• Whether the patents are listed in the Orange Book.
• Whether pediatric exclusivity extends the effective protection period.
• Whether Novartis has manufacturing know-how that is difficult to reproduce.

Manufacturing know-how can provide practical protection even where patent protection is limited. Small-particle or multiparticulate formulations may require specialized granulation, coating, blending and content-uniformity controls. Those barriers can delay entry, but they do not substitute for enforceable patent claims or regulatory exclusivity.

What licensing deals support ENTRESTO SPRINKLE?

ENTRESTO was developed and commercialized by Novartis under rights associated with sacubitril and the sacubitril/valsartan combination. Public reporting does not identify a separate licensing transaction specifically tied to ENTRESTO SPRINKLE.

The formulation appears to be a Novartis lifecycle-management product rather than a separately licensed external asset. Its value should therefore be analyzed within Novartis’s internal product strategy, manufacturing network and broader ENTRESTO franchise.

What generic launch scenarios exist?

Three scenarios are commercially relevant.

Scenario 1: tablet generic entry before sprinkle competition

This would create rapid adult-market erosion while leaving the pediatric and dysphagia segment relatively protected. Novartis could maintain higher net pricing in the sprinkle niche.

Scenario 2: coordinated tablet and sprinkle competition

This would produce broader substitution and reduce the formulation’s ability to protect franchise revenue. Payers could prefer low-cost generic tablets for patients who can swallow them.

Scenario 3: delayed or limited generic penetration

Patent litigation, settlements, manufacturing constraints or limited payer substitution could preserve branded ENTRESTO revenue longer than statutory expiry dates suggest. This scenario would benefit both the core tablets and the sprinkle product, although it depends on the actual litigation record and market access terms.

Key Takeaways

• ENTRESTO SPRINKLE is an oral-pellet formulation of sacubitril/valsartan designed primarily for pediatric patients and people unable to swallow tablets.
• Novartis does not report ENTRESTO SPRINKLE revenue separately.
• The product’s financial importance is likely to be lifecycle protection, not a standalone multibillion-dollar market.
• Total ENTRESTO revenue was approximately $6 billion in 2023, making tablet-level generic erosion the dominant financial risk.[2]
• Generic and Paragraph IV exposure must be analyzed separately for tablets and oral pellets.
• Biosimilar risk does not apply because sacubitril/valsartan is a small-molecule drug.
• Formulation patents, manufacturing know-how and pediatric exclusivity could preserve a specialized branded segment after tablet generic entry.
• The FDA Orange Book and relevant litigation dockets are the controlling sources for current patent coverage and launch restrictions.

FAQs About ENTRESTO SPRINKLE

Is ENTRESTO SPRINKLE a new drug or a new formulation?

It is a new dosage form of the established sacubitril/valsartan combination, not a new active pharmaceutical ingredient.

Can ENTRESTO SPRINKLE replace ENTRESTO tablets for adults?

It may be used when the labeled dosing and administration requirements are met, but tablets remain the principal adult formulation. Prescribing decisions depend on patient ability to swallow and the approved product labeling.

Does ENTRESTO SPRINKLE have orphan-drug exclusivity?

The product is not treated as a biologic, and its commercial protection should not be assumed to arise from orphan-drug exclusivity. Patent and pediatric-exclusivity analysis is more relevant.

Will generic sacubitril/valsartan tablets automatically compete with ENTRESTO SPRINKLE?

They will compete for patients who can use tablets, but tablet approval does not automatically establish therapeutic or regulatory equivalence to an oral-pellet formulation.

What is the main investment risk for ENTRESTO SPRINKLE?

The principal risk is that broad generic erosion of adult ENTRESTO tablets will reduce franchise economics before the sprinkle formulation generates enough pediatric or specialty revenue to offset the decline.

References

1. U.S. Food and Drug Administration. (2024). ENTRESTO SPRINKLE (sacubitril and valsartan) oral pellets: Prescribing information.
2. Novartis AG. (2024). Annual report 2023. Basel, Switzerland: Novartis.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. Washington, DC: FDA.