ENTRESTO Drug Patent Profile

Which patents cover Entresto, and when can generic versions of Entresto launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTRESTO

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	11,135,192
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes	9,388,134*PED				Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes	8,877,938		Y	Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No	11,135,192
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No	11,058,667
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No	9,388,134*PED				Y

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
Germany	60315795
Mexico	2015002432	INHIBIDORES DE LA NEP PARA EL TRATAMIENTO DE ENFERMEDADES CARACTERIZADAS POR EL ENSANCHAMIENTO O REMODELACION AURICULAR. (NEP INHIBITORS FOR TREATING DISEASES CHARACTERIZED BY ATRIAL ENLARGEMENT OR REMODELING.)
Brazil	112015003067
European Patent Office	1948158	COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Norway	333191
China	104602711	Nep inhibitors for treating diseases characterized by atrial enlargement or remodeling

Supplementary Protection Certificates for ENTRESTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
2340828	C02340828/01	Switzerland		PRODUCT NAME: SACUBITRIL/VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
2340828	PA2021502	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; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	SPC/GB16/025	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/1058(NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2340828	C202130003	Spain		PRODUCT NAME: SACUBITRILO/VALSARTAN, COMO COMPLEJO SALINO DE SACUBITRILO, VALSARTAN Y SODIO, ES DECIR (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINA) / ESTER ETILICO DEL ACIDO ((2R,4S)-5-BIFENIL-4-IL-4-(3-CARBOXI-PROPIONIL AMINO)-2-METIL-PENTANOICO)) NA3 - X H2O, EN EL QUE X ES 0 A 3; NATIONAL AUTHORISATION NUMBER: EU/1/15/1058; DATE OF AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1058; DATE OF FIRST AUTHORISATION IN EEA: 20151119

Investment Scenario and Fundamentals Analysis for ENTRESTO

Last updated: February 19, 2026

Summary:
ENTRESTO, developed by Novartis, is a combination drug containing sacubitril and valsartan used to treat heart failure with reduced ejection fraction (HFrEF). It has gained market approval globally, bolstered by strong clinical trial data and favorable regulatory reviews. The drug's market presence, patent lifecycle, competitive landscape, and growth potential influence its investment profile.

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What Is ENTRESTO and Its Market Position?

ENTRESTO (sacubitril/valsartan) received FDA approval in July 2015 and EMA approval in November 2015. It addresses HFrEF by antagonizing the renin-angiotensin system and enhancing natriuretic peptides, leading to improved patient outcomes. As of 2022, ENTRESTO held approximately 80% of the market share among SGLT2 inhibitors and ARNI (angiotensin receptor-neprilysin inhibitor) therapies in the HFrEF segment in the U.S.

Market Data:

• Estimated global sales for 2022: $4.6 billion[1]
• Expected CAGR (2023-2030): 9% (CAGR estimates based on IQVIA and Novartis reports)
• Key markets: U.S., Europe, Japan, and emerging markets

Patent and Regulatory Timeline

Year	Event	Notes
2014	Patent application filed	Broad patent coverage for sacubitril/valsartan combination
2015	FDA and EMA approvals	Market launch in key regions
2022	Patent expiry forecast in major markets	No patent expiration before 2027 in the U.S. and Europe, extending exclusivity
2023	Patent litigations and biosimilar entry in emerging markets	Some challenges expected outside core markets

Patent protection is projected to last until 2027-2028, supported by formulation patents and data exclusivity periods. Patent expiration risks could translate into increased biosimilar competition post-2027, impacting market share and pricing.

Competitive Landscape

Competitor	Product	Mechanism	Market Share (2022)	Remarks
Novartis	ENTRESTO	ARNIs	~80%	Dominant in HFrEF
Boehringer Ingelheim	Jardiance (empagliflozin)	SGLT2 inhibitor	Concentrates on diabetes and heart failure	Growing competition in heart failure with SGLT2 inhibitors
AstraZeneca	Farxiga (dapagliflozin)	SGLT2 inhibitor	Significant in HF and diabetes	Launching combination therapies
Others	Generic ARBs and ACE inhibitors	Limited market share	Post-patent expiration	Competitive pricing pressures

Growth Drivers and Risks

Growth Drivers

• Efficacy and Clinical Trials: The PARADIGM-HF trial demonstrated 20% reduction in cardiovascular death and hospitalization versus enalapril, leading to broad adoption.
• Regulatory Approvals: Expanding indications in HFpEF (heart failure with preserved ejection fraction), with ongoing trials targeting broader patient populations.
• Market Expansion: Growing awareness and treatment adoption in emerging markets.
• Pricing and Reimbursement: Favorable reimbursement policies in key markets support sustained revenue.

Risks

• Patent Expiry: Expected around 2027 in primary markets, leading to biosimilar competition.
• Generic Entry: Potential for biosimilars or generics to reduce pricing power post-patent.
• Regulatory Changes: Stricter pricing controls, especially in Europe and emerging markets, could pressure margins.
• Competitive Innovation: Entry of next-generation therapies, including novel HF drugs and SGLT2 class advances, could erode ENTRESTO’s market dominance.

Investment Outlook

Aspect	Details
Revenue Stability	Historically strong, with minimal impact until 2027 due to patent protections.
Growth Potential	Sustained through expansion into HFpEF and geographic markets.
Competitive Threats	Will increase with patent expiry, market share, and pricing pressures.
R&D Pipeline	Novartis exploring fixed-dose combinations and potential new indications.
Regulatory Environment	Generally supportive, with some risks of pricing reforms.

Financial Metrics and Valuation Indicators

Metric	2022 (Novartis Report)	Notes
Revenue from ENTRESTO	$4.6 billion	Represents ~12% of Novartis total revenue
Operating Margin	60%	Stable, elevated by patent exclusivity
R&D Investment	~$9 billion annually	Focused on cardiovascular and metabolic research

Valuation models incorporate projected revenue growth, patent expiry timelines, and competitive dynamics. The current market cap premium reflects ENTRESTO’s market leader status but faces downward revision post-2027 without pipeline expansion.

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Key Takeaways

• Market Dominance: ENTRESTO is the leading HFrEF therapy; its clinical profile and approval status sustain its market share.
• Patent Protection: Secures revenue until around 2027; post-expiry, biosimilar competition may significantly impact pricing.
• Growth Opportunities: Expansion into HFpEF, emerging markets, and new indications could preserve revenues.
• Competitive Risks: Next-generation therapies and biosimilars threaten long-term profitability.
• Regulatory Environment: Pricing reforms and reimbursement policies in major regions can influence future performance.

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FAQs

1. When will ENTRESTO’s patents expire?
Most primary patents are likely to expire between 2027 and 2028, but secondary patents and formulations could extend exclusivity slightly beyond.

2. What are the main competitors to ENTRESTO?
SGLT2 inhibitors like Jardiance and Farxiga, and future combination therapies, pose the primary competition post-patent expiry.

3. How does ENTRESTO perform in clinical trials?
The PARADIGM-HF trial proved a 20% reduction in cardiovascular death and hospitalization compared to enalapril, supporting widespread adoption.

4. What are the growth prospects beyond patent expiry?
Expansion into HFpEF indications and new markets, along with potential pipeline drugs, could sustain growth.

5. What are key risks for long-term investment?
Timing of patent cliffs, biosimilar entry, regulatory changes, and emerging therapies are primary long-term risks.

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References

[1] IQVIA. (2023). Pharmaceutical Market Tracker.
[2] Novartis. (2023). 2022 Annual Report.
[3] U.S. Food and Drug Administration. (2015). Approval documents for ENTRESTO.
[4] European Medicines Agency. (2015). EMA approval letter for ENTRESTO.