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 Ltd, MSN, Novugen Pharma Sdn, Somerset Theraps Llc, Torrent, and Zydus Pharms, and is included in sixteen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sacubitril; valsartan has one hundred and seventy-four patent family members in forty countries.

Twenty-four 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:	24
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
Laurus	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213676-002	May 28, 2024	AB	RX	No	No
Zydus Pharms	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213719-002	Jul 9, 2024	AB	RX	No	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes

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
European Patent Office	4212152
Croatia	P20201605
Taiwan	I634887
South Korea	20200111822	심방 확장 또는 재형성을 특징으로 하는 질환을 치료하기 위한 NEP 억제제 (NEP NEP INHIBITORS FOR TREATING DISEASES CHARACTERIZED BY ATRIAL ENLARGEMENT OR REMODELING)

Supplementary Protection Certificates for sacubitril; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
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
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
2340828	2190001-4	Sweden		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (S)-N-VALERYL-N-2-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL-METHYL-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER)NA3 - X H2O, WHEREIN X IS 0 TO 3; REG. NO/DATE: EU/1/15/1058 20151123

Sacubitril/Val­sartan Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

Where does sacubitril/valsartan sit in the heart-failure market?

Sacubitril/valsartan is a branded blockbuster in chronic heart failure with reduced ejection fraction (HFrEF) and is also established in broader heart-failure segments depending on local label and reimbursement. The product competes against renin-angiotensin system inhibitors (ACE inhibitors, ARBs) and other guideline-directed therapies (beta blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors, and device therapies). Commercial demand is driven by: (1) guideline uptake, (2) payer coverage and prior authorization pathways, (3) conversion of ACE/ARB patients after guideline revisions, and (4) the pace of entry of generic or biosimilar-equivalent products (where applicable by geography and patent status).

What has been the financial trajectory and why?

Globally, the financial trajectory of sacubitril/valsartan has followed the standard pattern of late-stage life-cycle growth into peak sales, then a gradual deceleration as competitive pressures rise, patent cliffs approach, and payer formularies tighten.

Sales trajectory (industry benchmarks)

Across major market trackers, the drug has been in the top tier of heart-failure sales for years, with revenue declining over time after the peak period due to increasing price pressure and the onset of lower-cost alternatives in certain countries. The dominant commercial reality is that sacubitril/valsartan maintains strong category share in HFrEF and remains a default option in many formularies, but its growth rate is increasingly constrained by payer economics and competitive switching to less expensive therapy options.

Key financial drivers

1. Formulary position and reimbursement

   • Sustained access in hospital and outpatient programs is the largest revenue stabilizer.
   • Reimbursement policies increasingly tie coverage to documented HFrEF criteria and physician specialty input.

2. Competitive substitution

   • ACE inhibitors and ARBs remain widespread, and conversion requires clinical justification and reimbursement support.
   • SGLT2 inhibitors add incremental competition by changing the economics of “baseline” heart failure regimens.

3. Lifecycle pressure

   • As patent protection weakens in specific jurisdictions, generic entry compresses net price and accelerates volume share shifts.

How do patent and generic dynamics shape market outcomes?

Patent and regulatory status determine when generic or lower-cost entrants can launch, which drives step changes in net price. For sacubitril/valsartan, country-by-country patent and exclusivity outcomes drive a staggered erosion curve rather than a single global cliff.

Market impact framework

• Early life-cycle (on-patent dominance): Higher net price and stable payer access.
• Approaching expiration: Payers start negotiating rebates and formulary tier changes.
• Post-entry: Generic uptake typically causes the fastest net price drop; branded volume declines follow.

Operational implication for forecasting

Revenue forecasting for sacubitril/valsartan should model:

• launch timing by country,
• expected payer adoption curves (typically faster in commercial formularies than in restrictive specialty-only systems),
• and price erosion by channel (hospital versus retail).

What are the main market dynamics by customer and channel?

Customer segments

• Hospital-based cardiology programs: Higher prescribing concentration for HFrEF, often driving consistent demand.
• Outpatient specialists and large group practices: Strong continuity once a patient is established on therapy.
• Primary care influence: Usually indirect; heart-failure management remains specialty-led in many systems.

Channel economics

• Commercial payers: Formulary placement, copay design, and rebate intensity drive net sales.
• Government programs: Tendering and volume-based contracting can accelerate price compression after generic entry.

Which therapeutic and guideline forces support demand?

1. Clinical switching and persistence
   • Conversion from ACE inhibitors and ARBs to sacubitril/valsartan is persistent when patients tolerate therapy and when outcomes align with label and guideline recommendations.
2. Guideline and evidence reinforcement
   • Ongoing guideline updates keep sacubitril/valsartan within preferred sequences for HFrEF in many jurisdictions.
3. Combination therapy normalization
   • Patients increasingly receive multiple guideline-directed therapies; sacubitril/valsartan remains part of foundational regimens in many care pathways.

What do competitive pressures look like in practice?

Competitive set

• ACE inhibitors (e.g., enalapril classes in many markets)
• ARBs (e.g., valsartan, losartan, candesartan depending on region and indication)
• SGLT2 inhibitors used in heart failure settings (driving “re-prioritization” of treatment economics)

Competitive mechanics

• Net price pressure: Generics do not only reduce sacubitril/valsartan’s price. They also raise the benchmark price for competing ARB/ACE strategies through payer negotiations.
• Prescriber preference and continuity: Once on therapy, patient persistence often slows switching, delaying volume declines until generic substitution becomes operationally easier and financially safer.

How will the financial trajectory likely evolve under generic entry risk?

Scenario logic

• Base case (staggered erosion): Sales decline continues, with sharper drops in geographies where generic entry occurs and slower decline in markets with delayed entry.
• Upside case (strong payer entrenchment): Branded share holds longer in markets where formularies and contracting continue to favor sacubitril/valsartan despite lower-cost alternatives.
• Downside case (faster adoption curves): Generic or alternative uptake accelerates due to aggressive contracting, patient cost-share changes, and substitution incentives.

Quantitative forecasting approach (investor-grade)

To model net sales trajectory without relying on single-point assumptions, use:

• Country-level launch calendars,
• A tiered adoption curve by payer type (commercial, Medicaid, national health systems),
• and a price erosion factor based on observed history in other combination ARNI/RAAS branded products post-generic entry.

What does the regulatory and evidence base imply for commercialization?

Sacubitril/valsartan has an established evidence base and label-defined use in heart failure. In commercialization terms, this reduces “adoption friction” versus drugs that require new clinical endpoints for payers to underwrite use. Instead, the dominant bottlenecks become administrative (prior authorization), contracting (rebates and tendering), and economics (copays, net price).

What investment or R&D implications follow from these dynamics?

1. Near-term revenue is dominated by contracting rather than science
   • After label maturity, the biggest swings come from pricing and access.
2. Post-cliff share defense is channel-specific
   • Brands generally lose share fastest where formularies allow automatic substitution and where generic uptake is operationally simple.
3. Pipeline competition is additive, not substitutive
   • New heart failure drugs change regimen composition. Sacubitril/valsartan remains core in many sequencing patterns, but incremental therapy can cap growth.

Key Takeaways

• Sacubitril/valsartan remains a top heart-failure branded revenue engine, with demand supported by clinical persistence and guideline-aligned use.
• The financial trajectory shifts from growth to deceleration as payer economics tighten and competition increases.
• Patent and generic launch timing by geography drives the sharpest revenue erosion segments, producing a staggered post-peak decline rather than a single global cliff.
• Competitive pressure increasingly comes from contracting dynamics and additive combination regimens, which limit branded growth even when patient uptake stays steady.

FAQs

1. What primarily drives sacubitril/valsartan sales in mature markets?
   Formulary access, net pricing via rebates/tenders, and patient persistence in established therapy.

2. How does generic entry typically affect sacubitril/valsartan revenue?
   It compresses net price first, then accelerates volume share loss as substitution and contracting tighten.

3. Does competition come mostly from ACE inhibitors and ARBs, or from newer heart failure drugs?
   Both. RAAS competitors pressure net price and switching, while newer heart failure therapies reshape the regimen economics.

4. Why can branded share remain stable even as generic threats grow?
   Clinical continuity and administrative barriers (prior authorization, documentation requirements) slow switching.

5. What is the most reliable forecasting lever during patent transition?
   Country-by-country launch timing and payer adoption curves, not aggregate global assumptions.

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References

[1] European Medicines Agency. Entresto (sacubitril/valsartan): EPAR product information. EMA.
[2] U.S. Food and Drug Administration. Entresto (sacubitril and valsartan) label. FDA.
[3] Centers for Medicare & Medicaid Services. CMS National Coverage Determinations and reimbursement policy resources for heart failure therapies. CMS.
[4] National Institute for Health and Care Excellence. Technology appraisals and guidance covering sacubitril/valsartan and heart failure management. NICE.
[5] GlobalData (or equivalent industry dataset provider). Cardiology and heart failure drug sales forecasts and historical market analysis for ARNI therapies.