Sacubitril; valsartan - Generic Drug Details

What are the generic sources for sacubitril; valsartan and what is the scope of patent protection?

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, Torrent, and Zydus Pharms, and is included in fifteen NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sacubitril; valsartan has two hundred and eleven patent family members in forty-four countries.

Twenty-one suppliers are listed for this compound.

Summary for sacubitril; valsartan

International Patents:	211
US Patents:	11
Tradenames:	3
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	21
Clinical Trials:	105
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
Kafrelsheikh University	NA

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
Novugen Pharma Sdn	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213611-003	Jul 16, 2025	AB	RX	No	No
Msn	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213748-003	Jul 16, 2025	AB	RX	No	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No	8,877,938*PED				Y

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	218591-002	Apr 12, 2024	8,101,659
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024	8,101,659

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
Portugal	3294283
Lithuania	4212152
Australia	2013304949

Supplementary Protection Certificates for sacubitril; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1467728	132016000051059	Italy		PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123
2340828	2021C/502	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123

Market Dynamics and Financial Trajectory for SACUBITRIL; VALSARTAN

Last updated: November 17, 2025

Introduction

The combined medication of sacubitril and valsartan, marketed as Entresto, represents a significant advancement in the treatment landscape for heart failure. As a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI), it has shifted therapeutic paradigms and generated substantial commercial interest. This article examines the market dynamics influencing this drug's trajectory and explores its financial prospects in the evolving cardiovascular pharmacotherapy sector.

Clinical and Regulatory Background

Sacubitril/valsartan received FDA approval in 2015 for heart failure with reduced ejection fraction (HFrEF), replacing traditional ACE inhibitors and ARBs due to superior outcomes in reducing morbidity and mortality (reference [1]). The European Medicines Agency followed suit, acknowledging its enhanced efficacy. Recognized for its dual mechanism—combining vasodilation with neurohormonal modulation—its clinical profile has positioned it as a cornerstone in heart failure management.

Regulatory endorsements have enabled broad uptake, catalyzed by robust evidence from the PARADIGM-HF trial, demonstrating a 20% reduction in cardiovascular death and HF hospitalization versus enalapril (reference [2]). Despite its clinical dominance, the drug’s newer mechanism and improved safety profile have prompted ongoing discussions about its market expansion potential and competitive positioning.

Market Dynamics

Market Size and Growth Drivers

The global heart failure therapeutics market was valued at approximately USD 12.4 billion in 2022 and projected to grow at a CAGR of 8.2% through 2030 [3]. The aging population, increasing prevalence of cardiovascular diseases (CVD), and growing awareness of advanced therapies underpin this trend. Specifically, HFrEF accounts for nearly half of all heart failure cases, making sacubitril/valsartan’s primary target population sizable.

The compelling clinical evidence and positive reimbursement policies have accelerated adoption across developed markets—North America, Europe, and parts of Asia. Additionally, expanding indications to include heart failure with preserved ejection fraction (HFpEF)—pending regulatory approvals—could significantly widen the market scope.

Competitive Landscape

Sacubitril/valsartan faces competition from traditional RAAS inhibitors, such as enalapril and valsartan, which dominate due to established safety profiles and cost advantages. However, its superior efficacy and favorable tolerability have facilitated a shift toward prescription. Other emerging therapies, such as SGLT2 inhibitors (e.g., dapagliflozin), are also entering the heart failure market, posing potential challenges.

Pharmaceutical giants like Novartis, which markets Entresto, have invested heavily in clinical trials and marketing campaigns to sustain market share. Meanwhile, generic versions and biosimilar entries could impact pricing and access, especially in emerging markets.

Pricing and Reimbursement Policies

Pricing strategies play a pivotal role in market penetration. In the US, the drug’s list price stood at approximately USD 470 per month in 2022, with insurance coverage and rebates affecting actual patient costs [4]. In major European markets, reimbursement negotiations have generally favored the addition of sacubitril/valsartan to standard care, though at higher prices compared to alternatives.

Expanding coverage, especially in low- and middle-income countries, hinges on demonstrating cost-effectiveness. Cost-effectiveness analyses emphasize the drug’s ability to reduce hospitalization costs and improve survival, supporting favorable reimbursement decisions.

Regulatory Expansions and Clinical Developments

Ongoing clinical trials aim to extend sacubitril/valsartan’s indications. The PARAGON-HF trial, evaluating its efficacy in HFpEF (published in 2021), yielded mixed results but indicated potential benefits, prompting regulatory discussions [5]. Positive outcomes could broaden market access, especially in demographic segments with limited current options.

Furthermore, real-world evidence studies reinforce the drug’s safety and effectiveness outside controlled trials, encouraging wider adoption and reimbursement accessibility.

Financial Trajectory

Revenue Projections and Market Penetration

Novartis reported worldwide sales of approximately USD 4.2 billion for sacubitril/valsartan in 2022, reflecting rapid uptake in key markets [6]. The drug’s revenue trajectory is projected to CAGR at roughly 10% over the next five years, driven by expanding indications, increased adoption, and broadened access.

Emerging markets, characterized by rising CVD burdens and improved healthcare infrastructure, represent untapped opportunities. Similarly, clinical trial successes in HFpEF could unlock additional revenue streams.

Pricing Strategies and Margins

Pricing remains a critical lever; while premium pricing sustains margins in developed countries, price sensitivity in emerging markets necessitates tiered strategies or differential pricing. Market exclusivity and patent protection—expected to last until at least 2030—afford Novartis a temporary monopoly, supporting premium margins.

The potential introduction of biosimilars or generics post-patent expiry could erode market revenue, but strategic patent extensions and supplementary indications can mitigate this risk.

Market Risks and Opportunities

Key risks include competitive pressures from novel therapies, pricing pressures, and regulatory hurdles. Conversely, increasing disease prevalence, favorable clinical data, and expanding indications offer upside potential. Furthermore, integration into combination therapy regimens could generate synergies, boosting long-term revenues.

Market Forecast and Strategic Outlook

The trajectory of sacubitril/valsartan indicates a sustained growth pattern propelled by expanding clinical evidence and market acceptance. Strategic focus areas include:

• Geographic Expansion: Targeting emerging markets and intensifying efforts in Europe and Asia.

• Indication Broadening: Supporting regulatory approval for HFpEF and potentially other cardiovascular conditions.

• Pricing Optimization: Balancing access with margins through tiered pricing and formulary negotiations.

• Clinical Research: Investing in trials to reinforce efficacy, safety, and expanded indications.

Key Takeaways

• Sacubitril/valsartan has established itself as a transformative therapy in HFrEF, with accelerated adoption in major markets.
• The global cardiovascular therapeutics market, driven by demographic trends, will likely sustain a high growth rate, favoring sacubitril/valsartan’s revenue prospects.
• Competitive forces, payer dynamics, and patent protections will influence the financial trajectory; strategic innovations can mitigate risks.
• Clinical trials extending indications, especially into HFpEF, will be critical to unlocking additional market potential.
• Adoption in emerging markets and expanded reimbursement pathways will be pivotal in achieving long-term revenue growth.

FAQs

1. What is the primary mechanism of sacubitril/valsartan?
   It combines neprilysin inhibition (via sacubitril) with angiotensin receptor blockade (via valsartan), promoting vasodilation and neurohormonal modulation to improve heart failure outcomes.

2. When will sacubitril/valsartan face patent expiration?
   Expected around 2030, allowing generics or biosimilars to enter the market, potentially impacting pricing and revenue.

3. Are there ongoing clinical trials for sacubitril/valsartan?
   Yes, notably studies investigating efficacy in HFpEF and other cardiovascular conditions, aiming to expand indications.

4. What factors influence the drug’s market penetration globally?
   Clinical evidence, reimbursement policies, pricing competitiveness, and healthcare infrastructure significantly shape adoption rates.

5. How does sacubitril/valsartan compare cost-wise to traditional therapies?
   While generally priced higher than ACE inhibitors or ARBs, its superior efficacy translates into reduced hospitalizations, providing favorable cost-effectiveness profiles in many markets.

---

References

[1] US Food and Drug Administration. (2015). FDA approves Entresto to treat heart failure.
[2] McMurray, J. J., et al. (2014). The New England Journal of Medicine. PARADIGM-HF Trial Results.
[3] MarketsandMarkets. (2022). Heart Failure Therapeutics Market.
[4] Novartis Annual Report. (2022).
[5] Solomon, S. D., et al. (2021). JAMA. PARAGON-HF trial results.
[6] Novartis. (2022). Sales Data and Market Share Reports.