Is Sacubitril + Valsartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 18 valid registrations of Sacubitril + Valsartan, including Duvalsa (24,26 mg,mg, Film-coated tablet, SAR 186.45); Duvalsa (49,51 mg,mg, Film-coated tablet, SAR 186.45); Duvalsa (97,103 mg,mg, Film-coated tablet, SAR 372.95); ENTRESTO (25.7,24.3 mg,mg, Film-coated tablet, SAR 200.80); ENTRESTO (51.4,48.6 mg,mg, Film-coated tablet, SAR 200.80).

Is Sacubitril + Valsartan approved by the US FDA?

Drugs@FDA lists 18 application product lines for Sacubitril + Valsartan, including ENTRESTO (Prescription); ENTRESTO SPRINKLE (Prescription); SACUBITRIL AND VALSARTAN (Prescription); SACUBITRIL AND VALSARTAN (Prescription); SACUBITRIL AND VALSARTAN (Prescription).

Is Sacubitril + Valsartan authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Sacubitril + Valsartan: Entresto, Neparvis.

Active substances

Sacubitril + Valsartan

SFDA 18
US FDA 18
EMA 2
Health Canada 9
US price lines 8
NHS prices 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Duvalsa	24,26 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 186.45	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Duvalsa	49,51 mg,mg	Film-coated tablet · Oral use	30 Blister	SAR 186.45	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Duvalsa	97,103 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 372.95	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
ENTRESTO	25.7,24.3 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 200.80	NCE · Prescription	NOVARTIS	Valid
ENTRESTO	51.4,48.6 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 200.80	NCE · Prescription	NOVARTIS	Valid
ENTRESTO	102.8,97.2 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 401.60	NCE · Prescription	NOVARTIS	Valid
Entuval	97,200 mg,mg	Film-coated tablet · Oral use	56 Blister	SAR 321.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Entuval	49,100 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 160.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Entuval	24,50 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 160.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Ossentiv	24,26 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 160.65	Generic · Prescription	Boston Oncology Arabia	Valid
Ossentiv	49,51 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 160.65	Generic · Prescription	Boston Oncology Arabia	Valid
Ossentiv	97,103 mg,mg	Film-coated tablet · Oral use	28 Blister	SAR 242.95	Generic · Prescription	Boston Oncology Arabia	Valid
SACVALY	97,103 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 344.25	Generic · Prescription	Saudi Amarox	Valid
SACVALY	49,51 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 344.25	Generic · Prescription	Saudi Amarox	Valid
SACVALY	24,26 mg,mg	Film-coated tablet · Oral use	60 Blister	SAR 344.25	Generic · Prescription	Saudi Amarox	Valid
Saventi	24,26 mg,mg	Film-coated tablet · Oral use	60 Bottle	SAR 401.60	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Saventi	49,51 mg,mg	Film-coated tablet · Oral use	60 Bottle	SAR 401.60	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Saventi	97,103 mg,mg	Film-coated tablet · Oral use	60 Bottle	SAR 401.60	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid

Indications — CHI Daman Drug Formulary

CARDIOMYOPATHY; CONGESTIVE HEART FAILURE

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ENTRESTO	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	NOVARTIS PHARMS CORP	Prescription	7 Jul 2015
ENTRESTO SPRINKLE	6MG;6MG; 15MG;16MG	capsule, pellets · oral	NOVARTIS	Prescription	12 Apr 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	CRYSTAL	Prescription	28 May 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	LAURUS	Prescription	28 May 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	ALEMBIC	Prescription	28 May 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	ZYDUS PHARMS	Prescription	9 Jul 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	TORRENT	Prescription	22 Aug 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	BIOCON PHARMA	Prescription	30 Aug 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	ALKEM LABS LTD	Prescription	16 Sep 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	MACLEODS PHARMS	Prescription	16 Oct 2024
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	LUPIN	Prescription	8 Jan 2025
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	DR REDDYS	Prescription	13 Jan 2025
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	NOVUGEN PHARMA SDN	Prescription	16 Jul 2025
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	MSN	Prescription	16 Jul 2025
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	HETERO LABS LTD III	Prescription	17 Jul 2025
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	SOMERSET THERAPS LLC	Prescription	20 Jan 2026
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	UMEDICA	Prescription	4 Aug 2026
SACUBITRIL AND VALSARTAN	24MG;26MG; 49MG;51MG; 97MG;103MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	2 Sep 2026

EMA European Union — centrally authorised medicines

Entresto Novartis Europharm Limited · Authorised · authorised 19 Nov 2015 · ATC C09DX04

Therapeutic indication (EMA)

Paediatric heart failure Entresto 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 failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Neparvis Novartis Europharm Limited · Authorised · authorised 26 May 2016 · ATC C09DX04

Therapeutic indication (EMA)

Paediatric heart failure Neparvis 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 failure Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ENTRESTO	02446928	26 MG; 24 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
ENTRESTO	02446936	49 MG; 51 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
ENTRESTO	02446944	97 MG; 103 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
PMS-SACUBITRIL-VALSARTAN	02564432	24 MG; 26 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-SACUBITRIL-VALSARTAN	02564440	51 MG; 49 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-SACUBITRIL-VALSARTAN	02564459	103 MG; 97 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ SACUBITRIL-VALSARTAN	02549018	26 MG; 24 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ SACUBITRIL-VALSARTAN	02549026	51 MG; 49 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ SACUBITRIL-VALSARTAN	02549034	103 MG; 97 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ENTRESTO 24 MG-26 MG TABLET	$11.5927	per EA	23 Sep 2026
US NADAC	ENTRESTO 49 MG-51 MG TABLET	$11.56059	per EA	23 Sep 2026
US NADAC	ENTRESTO 97 MG-103 MG TABLET	$11.58867	per EA	23 Sep 2026
US NADAC	ENTRESTO SPRINKLE 15-16 MG PLT	$11.60672	per EA	23 Sep 2026
US NADAC	ENTRESTO SPRINKLE 6-6 MG PELLET	$11.6248	per EA	23 Sep 2026
US NADAC	SACUBITRIL-VALSARTAN 24-26 MG	$0.49855	per EA	23 Sep 2026
US NADAC	SACUBITRIL-VALSARTAN 49-51 MG	$0.53337	per EA	23 Sep 2026
US NADAC	SACUBITRIL-VALSARTAN 97-103 MG	$0.59213	per EA	23 Sep 2026
NHS Drug Tariff	Sacubitril 15mg / Valsartan 16mg granules in capsules for opening	£25.36	60 capsule	1 Oct 2026
NHS Drug Tariff	Sacubitril 24mg / Valsartan 26mg tablets	£45.78	28 tablet	1 Oct 2026
NHS Drug Tariff	Sacubitril 49mg / Valsartan 51mg tablets	£91.56	56 tablet	1 Oct 2026
NHS Drug Tariff	Sacubitril 6mg / Valsartan 6mg granules in capsules for opening	£10.14	60 capsule	1 Oct 2026
NHS Drug Tariff	Sacubitril 97mg / Valsartan 103mg tablets	£91.56	56 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.