Sacubitril; valsartan - Generic Drug Details

What are the generic sources for sacubitril; valsartan and what is the scope of freedom to operate?

Sacubitril; valsartan is the generic ingredient in three branded drugs marketed by Novartis, Novartis Pharms Corp, Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Dr Reddys, Hetero Labs Ltd Iii, Laurus, Lupin, Macleods Pharms, MSN, Novugen Pharma Sdn, Somerset Theraps Llc, Torrent, Umedica, and Zydus Pharms, and is included in seventeen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

Summary for sacubitril; valsartan

International Patents:	174
US Patents:	9
Tradenames:	3
Applicants:	16
NDAs:	16
Finished Product Suppliers / Packagers:	27
Clinical Trials:	108
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sacubitril; valsartan
DailyMed Link:	sacubitril; valsartan at DailyMed

Recent Clinical Trials for sacubitril; valsartan

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

Sponsor	Phase
Martin Rohacek	PHASE4
Ifakara Health Institute (IHI)	PHASE4
Shanghai Chest Hospital	PHASE2

See all sacubitril; valsartan clinical trials

Pharmacology for sacubitril; valsartan

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

Anatomical Therapeutic Chemical (ATC) Classes for sacubitril; valsartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for SACUBITRIL; VALSARTAN

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 sacubitril; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Crystal	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213605-003	May 28, 2024	AB	RX	No	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No
Somerset Theraps Llc	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	219983-003	Jan 20, 2026	AB	RX	No	No

Expired US Patents for sacubitril; valsartan

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

EU/EMA Drug Approvals for sacubitril; valsartan

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 sacubitril; valsartan

Country	Patent Number	Title	Estimated Expiration
Australia	2017215530
Australia	2019280026
Canada	3010778

Supplementary Protection Certificates for sacubitril; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	CA 2021 00001	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. 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
1948158	C20160014 00383	Estonia		PRODUCT NAME: SAKUBITRIIL/VALSARTAAN;REG NO/DATE: EU/1/15/1058 23.11.2015

Sacubitril/Valsartan Market Dynamics and Financial Trajectory (Entresto) vs. Heart Failure Competitors: Revenue Drivers, Pricing, Patent/Generic Overhang, and Share Shifts

Last updated: June 26, 2026

Executive summary

• Sacubitril/valsartan (Entresto, Novartis) has been a high-value heart failure block during the rise of ARNI therapy, with revenue sustained by guideline penetration, dose optimization, and payer adoption of ARNI over ACE inhibitors/ARBs.
• Financial trajectory is shaped by (1) continued label expansion and real-world conversion from ACEi/ARB, (2) competitive pressure from SGLT2 inhibitors and MRAs that share morbidity-mortality benefit, (3) international pricing and reimbursement dynamics, and (4) generic and biosimilar-adjacent risk from potential “at-risk” supply timing for small-molecule ARNI combinations and their formulation/manufacturing IP.
• The most material near- to mid-term risks to growth are price pressure in developed markets, formulary tightening tied to budget impact, and slower uptake where payer restrictions require prior ACEi/ARB failure or step therapy.

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How has sacubitril/valsartan (Entresto) performed financially since launch?

Quick answer: Entresto revenue scaled rapidly after approval by building prescriber trust and guideline alignment, then transitioned into a growth-and-defense phase as competing heart failure therapies consolidated share. The revenue profile typically shows mid-single to high-single digit growth when ARNI conversion stays strong, with deceleration where payer restrictions and price compression increase.

Revenue pattern drivers (what moves sacubitril/valsartan sales)

• Guideline adoption: ARNI uptake depends on endorsement by cardiology/heart failure guidelines for HFrEF and evolving use in broader phenotypes where clinicians accept ARNI’s mortality benefit.
• Dose conversion and persistence: Entresto’s economics improve when patients are titrated and persist long enough to sustain prescription volumes.
• Formulary access: Uptake accelerates when national formularies and major commercial plans cover ARNI without heavy step edits.

What typically causes revenue acceleration vs. slowdown

• Acceleration signals
  • Strong new-start rates and increased proportion of patients switched from ACE inhibitors or ARBs.
  • Better-than-expected persistence due to improved tolerability management (hypotension monitoring, renal function monitoring).
• Slowing signals
  • Higher prescription decline due to payer step therapy or restrictive prior authorization.
  • Price/mix headwinds from competitive contracting and tendering in markets with aggressive HTA behavior.

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What market dynamics affect sacubitril/valsartan growth in heart failure?

Quick answer: Entresto’s market is governed by heart failure epidemiology, ARNI treatment algorithms, payer economics, and competition from SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), MRAs, beta-blockers, and device therapy.

Competition structure: ARNI vs. complementary classes

• SGLT2 inhibitors: Capture incremental morbidity and mortality benefit, shifting “default” background therapy and increasing the number of tablets per patient class.
• MRAs (mineralocorticoid receptor antagonists): Continue to grow as foundational therapy.
• ACE inhibitors/ARBs: Entresto typically displaces these in eligible HFrEF patients, but substitution depends on payer and clinical constraints.

Payer behavior and reimbursement constraints

• ARNI coverage is often paired with:
  • documented HFrEF diagnosis,
  • step therapy language (ACEi/ARB use first),
  • prior authorization tied to echocardiographic parameters and symptom class.
• Budget impact pressures tend to show up as:
  • tighter patient criteria,
  • higher cost-sharing,
  • increased use of preferred generics in other HF classes while keeping ARNI as a brand-limited category.

Country-by-country dynamics (high-level)

• US: Broad access is supported by entrenched guideline practice, but commercial and Medicare Part D pricing changes can impact net revenue.
• EU: HTA and tendering cycles can produce sharp net price moves. Uptake is often slower in systems with stricter reimbursement for brand ARNI.
• Emerging markets: Growth is constrained by affordability and contracting; uptake increases when local distribution networks mature and discounts scale.

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When does sacubitril/valsartan lose exclusivity and how does that affect financial outlook?

Quick answer: Exclusivity and patent expiry timing for Entresto are the central variables for any generic entry scenario in the US. The financial trajectory typically remains stable until an actionable patent cliff approaches; then revenue risk rises sharply around potential Paragraph IV windows and any post-settlement entry.

How exclusivity timelines translate into revenue risk

• Before patent expiry: Brand revenue stays exposed primarily to pricing pressure and competitive substitution.
• Near expiry: Risk increases from:
  • incentives for generics to seek approvals,
  • litigation-driven “delay and release” scenarios,
  • payer re-contracting in anticipation of generic availability.
• After authorized generic or generic launches: Rapid uptake typically occurs if the product is formulary preferred and pricing is attractive.

What to monitor for real-world financial impact

• net price reductions in major markets,
• formulary substitution,
• changes in copay cards and patient assistance strategies,
• manufacturing supply credibility for any generic entrants.

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What patents protect sacubitril/valsartan (Entresto) in the US, and where is the patent estate strongest?

Quick answer: Entresto’s US patent estate is typically concentrated in composition, formulation, and method-of-use claims, with additional protection in manufacturing and process-related claims. Strength is usually highest where claims are broadly applicable to ARNI fixed-dose products and dosing regimens rather than narrow manufacturing steps.

Patent estate categories that matter commercially

• Composition of matter: Protects the active combination and key chemical forms.
• Formulation and dosage: Protects film-coated tablets, specific dosage strengths, and formulation approaches that enable stability and bioavailability.
• Methods of use: Protects HFrEF and other labeled or clinically used dosing regimens.

How patent strength changes “at-risk” viability

• Narrow formulation claims can be designed around, lowering litigation settlement economics.
• Broad method-of-use claims are harder to design around and can force settlement.

(No patent-number mapping is provided here because the request does not include specific jurisdiction/date targets, and an accurate list requires a definitive Orange Book/patent-schedule dataset.)

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How strong is the Orange Book status for Entresto and what does it imply for generic entry risks?

Quick answer: Orange Book listings define regulatory exclusivity and patent coverage for listed drug products; any gap between approval pathway timing and patent expiry windows is where Paragraph IV risk concentrates.

What “Orange Book status” typically indicates for investors

• If multiple patents remain listed for each strength: higher likelihood of litigation and settlement delay.
• If coverage is patchy or expires unevenly by strength: partial risk exists for some strengths and slower share erosion rather than a single sharp drop.

Generic entry pathways that matter for this category

• ANDA-based generics for fixed-dose oral combinations.
• Any challenge strategy that targets one or more core patents.

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Has any generic or biosimilar strategy targeted sacubitril/valsartan via Paragraph IV challenges?

Quick answer: For long-running brand products like Entresto, market expectations usually center on ANDA Paragraph IV filings that attempt to trigger earlier generic entry. Financial exposure depends on whether challenges lead to:

• court outcomes that invalidate or narrow key patents,
• settlements that set delayed entry dates,
• authorized generic decisions that accelerate substitution.

(No specific filing/settlement dates are provided because they must be matched to an Orange Book patent list and litigation docket, which is not supplied.)

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What formulation patents and dosing protections matter for sacubitril/valsartan tablets?

Quick answer: For fixed-dose combinations, formulation and dosage-strength-specific patents can slow generic substitution if claims cover manufacturing or stability-critical aspects.

Key formulation protection themes

• tablet composition and excipient systems
• dissolution profiles and bioavailability-related specs
• methods to control particle size distribution
• process controls that affect consistency and shelf life

What generics typically do to enter

• match FDA-approved formulation specs,
• ensure bioequivalence for each strength,
• design around narrow process claims where possible.

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How does sacubitril/valsartan compare with ARBs and ACE inhibitors in market share and prescribing behavior?

Quick answer: Entresto is generally positioned as a replacement for ACEi/ARB in eligible HFrEF patients where mortality and morbidity benefit supports switching. Market share gains depend on step-therapy removal and clinical confidence, while ACEi/ARB remain entrenched in patients with contraindications or payer constraints.

Competitive displacement mechanics

• Clinical: clinicians switch when tolerability is acceptable and patients meet criteria.
• Economic: payers may maintain ACEi/ARB coverage as preferred until a strong cost-effectiveness narrative and budget impact favors ARNI.

Where ACEi/ARB retain share

• hypotension risk,
• renal impairment considerations,
• patient intolerance history,
• payer restrictions requiring ACEi/ARB exposure first.

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How does sacubitril/valsartan compete against SGLT2 inhibitors and other heart failure disease-modifying therapies?

Quick answer: SGLT2 inhibitors do not typically replace ARNI head-to-head; they add to standard of care. The revenue dynamic is that combined therapy increases total HF drug spend, but the sponsor’s net revenue can slow if initiation and titration are distributed among multiple brands and formularies rationalize cost.

Real-world adoption pattern

• SGLT2 inhibitors have become core background therapy and may be initiated earlier.
• Entresto adoption depends on when ARNI is introduced in the treatment algorithm and whether step therapy applies.

Net effect on Entresto revenue

• Positive: more eligible HF patients are treated and longevity improves, sustaining chronic drug populations.
• Negative: tablets and class competition can shift payer preferences and limit incremental ARNI starts.

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What are the key licensing, manufacturing, and contracting factors affecting sacubitril/valsartan net revenue?

Quick answer: Net revenue depends on the mix of contract pricing, rebates/discounts, wholesaler purchasing patterns, and supply reliability. In mature brands, manufacturing and contracting determine whether revenue growth keeps up with volume growth.

Commercial mechanics that drive financial trajectory

• rebates and managed care discounts: can increase when competitors pressure net prices
• government pricing: Medicaid and 340B dynamics influence margin
• tendering: in many non-US markets, procurement contracts define net price

Manufacturing/IP barriers as market risk modifiers

• fixed-dose combination supply constraints
• formulation change control if lifecycle management introduces line extensions

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Key Takeaways

• Entresto’s financial trajectory is driven by ARNI conversion from ACEi/ARB, persistence, and payer coverage breadth, with counterweights from price compression and HF class competition.
• Mid-term growth depends on how quickly ARNI remains embedded in guidelines and real-world pathways while SGLT2 inhibitors increase the total HF drug mix.
• Patent and exclusivity timing is the binary risk variable for generic substitution. When Paragraph IV or settlement-driven entry approaches, net revenue typically faces sharper downside than in the “on-patent” period due to payer re-contracting and substitution dynamics.
• The strongest commercial IP protection usually comes from broad composition, formulation, and method-of-use claims across multiple strengths, which tends to slow generic entry or force settlements.

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FAQs

1. How do heart failure guideline updates influence entecision and net sales trends for sacubitril/valsartan?
2. What payer step-therapy rules most often reduce sacubitril/valsartan new prescriptions?
3. How do SGLT2 inhibitor adoption rates change ARNI initiation timing and Entresto volume growth?
4. What typically happens to gross-to-net reductions for brands like Entresto when generic entry becomes likely?
5. How do dosage-strength-specific patent coverage differences affect the timing of generic substitution?

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References (APA)

No sources were provided in the prompt, and no Orange Book, litigation docket, or company financial filings were included. Therefore, no citations can be generated without risking incorrect or unverifiable details.