ENTRESTO Drug Patent Profile

When do Entresto patents expire, and what generic alternatives are available?

Entresto is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ENTRESTO 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

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

Summary for ENTRESTO

International Patents:	143
US Patents:	6
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	45
Patent Applications:	119
Drug Prices:	Drug price information for ENTRESTO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTRESTO
What excipients (inactive ingredients) are in ENTRESTO?	ENTRESTO excipients list
DailyMed Link:	ENTRESTO at DailyMed

See drug prices for ENTRESTO

Recent Clinical Trials for ENTRESTO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Bio-innova Co., Ltd	PHASE1
Viatris Inc.	PHASE1

See all ENTRESTO clinical trials

Pharmacology for ENTRESTO

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

Paragraph IV (Patent) Challenges for ENTRESTO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENTRESTO	Tablets	sacubitril; valsartan	24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg	207620	18	2019-07-08

US Patents and Regulatory Information for ENTRESTO

ENTRESTO is protected by six 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 Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes					Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for ENTRESTO

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

When does loss-of-exclusivity occur for ENTRESTO?

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

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Serbia

Slovenia

Spain

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E050870
Slovenia	1948158
Japan	2022020624

Supplementary Protection Certificates for ENTRESTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	2016C/026	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
2340828	CA 2021 00001	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. NO/DATE: EU/1/15/1058 20151123
1948158	C01948158/01	Switzerland		PRODUCT NAME: SACUBITRIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015

ENTRESTO: Market Dynamics and Financial Trajectory

Last updated: May 10, 2026

ENTRESTO (sacubitril/valsartan) is a prescription cardiovascular medicine that has moved from early uptake to sustained, high-value demand in heart failure with reduced ejection fraction (HFrEF) and, later, expanded labeling into heart failure with preserved ejection fraction (HFpEF) and additional chronic heart failure populations. Its revenue trajectory has tracked guideline adoption, payer coverage, and competitive dynamics across ACE inhibitor/ARB, ARNI, and device and hospital care pathways. The financial profile is also shaped by recurring manufacturing and supply ramp maturity, cohort growth after label expansions, and trade-down pressure from formulary competition as other biologics and small-molecule heart failure options compete for managed-care budgets.

How has ENTRESTO’s market grown from label expansion and guideline adoption?

ENTRESTO’s market dynamics are anchored in two drivers: (1) guideline inclusion and clinician behavior shifts in HFrEF, and (2) later expansions into HFpEF and broader chronic heart failure frameworks that extend prescriber use beyond the initial HFrEF base.

Label and use-case expansion that broadened addressable demand

Market segment	Clinical basis	Status (US)	Impact on uptake
HFrEF	ARNI compared to ACE inhibitor strategy in key outcomes trials	Approved and established	Established base and routinized prescribing
HFpEF and CKD-adjacent heart failure cohorts	Trial evidence plus later label refinement	Expanded over time	Adds incremental prescribers and payer beneficiaries

Sources: ENTRESTO US prescribing information for indications and population coverage [2]. Trial evidence underlying the initial standard-of-care shift is consistent with ARNI outcomes versus comparator ACE inhibition approaches described in pivotal publications [1].

Guideline and payer behavior

Market uptake in heart failure is not purely product-outcome driven; formulary placement and prior authorization patterns determine volume capture. ENTRESTO’s adoption has historically benefited from:

• Clinical confidence in morbidity and mortality outcomes in HFrEF, which reduces clinician hesitation relative to ACE inhibitors and ARBs [1].
• Payer acceptance for ARNI class therapy where outcomes data support higher-tier drug spending, especially when hospitalizations decrease and downstream costs reduce.

Operational implication for forecasts: once a drug reaches entrenched HFrEF prescribing behavior, growth tends to come from incremental patient matching (and label expansion) rather than “new prescriber” conversion alone. That shift typically changes the slope of revenue growth from early adoption to maintenance plus cohort growth.

What revenue trajectory has ENTRESTO shown and what does it imply for forward planning?

ENTRESTO’s financial trajectory is best measured through global revenue reporting (Novartis) and quarter-to-quarter volume plus net price movement in major markets. The revenue path reflects:

• sustained demand in chronic HFrEF populations
• label expansion contribution to additional HF subtypes
• pricing and reimbursement negotiation cycles with commercial and government payers
• competitive pressure from other ARB/ACE and emerging heart failure therapeutics

Revenue pattern from public company reporting

Novartis reports ENTRESTO revenues as part of its portfolio disclosure (including geographic and segment perspectives). Public disclosures show a persistent contribution to Novartis’ total oncology and pharmaceuticals portfolio earnings, with ENTRESTO remaining a core revenue asset during the 2016-2024 period.

Sources: Novartis annual reporting and financial statements describing ENTRESTO revenue contributions [3][4]. (Financial tables are not reproduced here due to the absence of a specific figure request and to avoid pulling partial or mismatched extracts.)

What typically drives year-over-year movement in ENTRESTO revenue

For high-value chronic cardiovascular products like ENTRESTO, revenue movement usually decomposes into:

• Unit growth from incident and prevalent patient capture (and label expansions)
• Net price changes due to rebates, discounts, and payer re-contracting
• Mix shifts across countries and subpopulations (HFrEF versus broader HF cohorts)
• Competition from ARBs/ACE inhibitors, generic substitution pressure where allowed, and newer HF classes that can displace hospital management strategies

Operational implication: when unit growth slows while net pricing is pressured by payer contracts, the product often continues to generate positive cash flows, but at a lower growth rate. That changes R&D and commercial investment prioritization from “scale” to “defend and optimize” (formulary strategy, adherence support, and lifecycle management).

How do competitive dynamics affect ENTRESTO’s pricing power and market share?

ENTRESTO competes primarily within heart failure pharmacotherapy ecosystems where clinicians already have established therapy pathways.

Main competition vectors

Vector	How it pressures ENTRESTO
ACE inhibitors and ARBs	Lower acquisition cost and existing formularies can slow switching in some payers and provider networks
ARNI competitive landscape	Any next-generation ARNI offering could reduce brand differentiation if it matches outcomes and dosing convenience
New heart failure therapies	Therapies across SGLT2 inhibitors, mineralocorticoid receptor antagonists, and device strategies can reallocate budget emphasis and patient management pathways

Why ENTRESTO retained resilience

ENTRESTO’s differentiation remains rooted in outcomes in HFrEF, which supports:

• preference for ARNI over ACE inhibitor class for eligible HFrEF patients
• payer acceptance when cost offsets from reduced hospitalization are compelling
• durable clinician behavior once patients tolerate therapy

Source: prescribing information supports the labeled indications for chronic heart failure populations, which keeps eligible patient supply in-scope over time [2]. Outcomes rationale aligns with pivotal trial results published in NEJM for HFrEF comparative strategy [1].

How do payer coverage and access constraints shape the financial trajectory?

Access is a core constraint for premium cardiovascular drugs because they often require:

• prior authorization (PA)
• step therapy documentation
• evidence of guideline-eligible clinical criteria (e.g., ejection fraction ranges)
• adherence monitoring and switching rules after stabilization

Practical effects on sales cadence

• PA can compress initial adoption velocity in a geography or payer plan.
• Once a drug becomes “preferred”, quarterly growth typically transitions from adoption-driven to patient-eligible pool-driven.
• Switching rules and discontinuation tolerability affect persistence. ENTRESTO’s tolerability management is reflected in its prescribing information dosing and safety requirements, which influence real-world persistence [2].

What safety, dosing, and label constraints matter for commercial outcomes?

Commercial outcomes in chronic heart failure therapy depend on whether patients stay on treatment long enough to realize outcomes and generate stable prescription volumes.

Key prescribing constraints that affect persistence

ENTRESTO dosing and contraindications influence patient selection and discontinuation risk:

• renal function and hypotension risk management
• concomitant use restrictions and blood pressure monitoring
• drug product safety profile driving adherence needs

Source: ENTRESTO US prescribing information for dosing, contraindications, and safety requirements [2].

What lifecycle and “next growth” levers exist for ENTRESTO?

Even when a core indication is mature, growth can continue via:

• label expansion into additional HF phenotypes (when supported by outcomes and regulatory review)
• new guideline updates that increase eligible proportions within HFrEF and HFpEF
• optimized dosing strategies and clinician education
• contracting and formulary strategy to reduce PA friction

Source: ENTRESTO prescribing information reflects ongoing indication and dosing frameworks that enable ongoing eligible patient identification [2]. Pivotal outcomes evidence supports the clinical case that supports guideline placement [1].

How does ENTRESTO’s financial trajectory compare to typical mature cardiovascular brands?

ENTRESTO fits a mature, high-value cardiovascular brand profile:

• early revenue ramp driven by label match and guideline adoption
• later growth driven by patient pool expansion, substitution dynamics with ACE/ARB, and payer dynamics
• mid-term volatility linked to pricing negotiations and broader HF competitive therapy mix

Typical maturity implications for investors and planners

Stage	Common pattern for ENTRESTO-style assets
Mid-to-late lifecycle	Growth rate slows; EBITDA contribution stays material; net price becomes the swing factor
Competitive pressure increases	Retention and formulary preference determine market share more than product novelty
Payer renegotiations	Quarterly results show larger swings vs unit-driven growth phases

Evidence anchor: ENTRESTO is positioned in chronic HF populations with long-term prescribing in its labeled indications [2], and its outcomes rationale underpins the sustained clinical pathway that keeps demand from collapsing after maturity.

Financial trajectory summary: what the data suggests about cash generation

ENTRESTO’s financial trajectory is best described as sustained high-revenue contribution with growth linked to:

• chronic patient persistence
• continuing identification of eligible HF patients
• incremental label or guideline-driven use
• pricing and contracting cycles across geographies

Novartis’ continued disclosure of ENTRESTO as a meaningful revenue driver in financial reporting is consistent with a “core asset” profile rather than a transient launch curve [3][4].

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Key Takeaways

1. Market growth is dominated by guideline adoption and label expansion from the initial HFrEF base toward broader chronic HF coverage, sustaining incremental demand beyond early adopters [1][2].
2. Financial trajectory reflects maturity dynamics: unit growth increasingly depends on eligible patient pool expansion and persistence, while net pricing and payer contracting become the main swing factors.
3. Competitive pressure is structural (ACE/ARB alternatives, payer step therapy, and newer HF therapies) and affects switching behavior, but ENTRESTO retains resilience through outcomes evidence and established clinical workflow [1][2].
4. Commercial durability depends on access mechanics including PA criteria and tolerability-driven adherence, both reflected in prescribing requirements that govern real-world persistence [2].

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FAQs

1) What is ENTRESTO’s core market in heart failure?
ENTRESTO is used in labeled chronic heart failure populations including HFrEF and later-expanded HF populations based on ejection fraction and clinical criteria in the US label [2].

2) What clinical evidence supported ENTRESTO’s adoption?
The product’s positioning in HFrEF is based on landmark outcomes evidence published for sacubitril/valsartan compared with an ACE-inhibitor strategy [1].

3) What drives quarterly revenue movement for premium heart failure drugs?
For products like ENTRESTO, quarterly movement typically comes from net price and rebate changes plus unit persistence and eligible patient growth, rather than discontinuous demand spikes.

4) How do payer rules affect ENTRESTO uptake?
Prior authorization and step therapy can limit early capture in specific plans; once preferred status and streamlined criteria are achieved, uptake shifts toward patient-eligibility growth [2].

5) Do safety and dosing requirements influence sales durability?
Yes. Tolerability and contraindications influence patient selection, discontinuation risk, and real-world persistence, shaping long-run volume stability [2].

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References

[1] McMurray, J. J. V., Packer, M., Desai, A. S., et al. (2014). Angiotensin-neprilysin inhibition versus enalapril in heart failure. New England Journal of Medicine.
[2] Novartis Pharmaceuticals Corporation. (n.d.). ENTRESTO (sacubitril and valsartan) prescribing information.
[3] Novartis. (2024). Annual report / Form 20-F financial reporting: Pharmaceuticals performance and key products (including ENTRESTO).
[4] Novartis. (2023). Annual report / Form 20-F financial reporting: Product revenue disclosures and key drivers.

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