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ENTRESTO Drug Patent Profile

When do Entresto patents expire, and what generic alternatives are available?

Entresto is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-three patent family members in forty-four countries.

The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. Five 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:	163
US Patents:	8
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	41
Patent Applications:	22
Drug Prices:	Drug price information for ENTRESTO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTRESTO
What excipients (inactive ingredients) are in ENTRESTO?	ENTRESTO excipients list
DailyMed Link:	ENTRESTO at DailyMed

See drug prices for ENTRESTO

Recent Clinical Trials for ENTRESTO

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

Sponsor	Phase
Dr. Reddy's Laboratories (Thailand) Limited	Phase 1
Instituto Nacional de Cardiologia Ignacio Chavez	Phase 2/Phase 3
Boehringer Ingelheim laboratory	Phase 2/Phase 3

See all ENTRESTO clinical trials

Pharmacology for ENTRESTO

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

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 eight US patents and one FDA Regulatory Exclusivity.

Patents protecting ENTRESTO

FDA Regulatory Exclusivity protecting ENTRESTO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes			Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No			Y
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024		RX	Yes	Yes
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024		RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015	AB	RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015	AB	RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015	AB	RX	Yes	Yes					Y

EU/EMA Drug Approvals for ENTRESTO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Neparvis	sacubitril, valsartan	EMEA/H/C/004343 Paediatric 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/004062 Paediatric 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 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
Israel	184027	תרכובת טריסודיום [3-((1s, 3r)-1-ביפניל-4-ילמתיל-3-אתוקסיקרבוניל-1-בוטילקרבמויל)פרופיונאט-(s)-'3-מתיל-'2-(פנטהנויל{" 2-(טטרזול-5-ילאט)ביפניל-'4-ילמתיל}אמינו)בוטיראט] המיפנטההידראט, תכשירים רוקחיים שלה, שיטה להכנתה ושימוש בה להכנת תרופות (Compound trisodium [3-((1s,3r)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(s)-3’-methyl-2’-(pentanoyl{2’’-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate] hemipentahydrate, its pharmaceutical compositions, method for its preparation and use thereof in the preparation of medicaments)
Israel	162661	PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS USEFUL FOR TREATING HYPERTENSION OR HEART FAILURE
Lithuania	2340828
Japan	4820056
Tunisia	SN07264	ORGANIC COMPOUNDS
Jordan	3492	تركيبات صيدلانية من مضاد مستقبل أنجيوتنسين ومثبط NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Spain	2449765

Supplementary Protection Certificates for ENTRESTO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1467728	1690021-9	Sweden		PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
1948158	C20160014 00383	Estonia		PRODUCT NAME: SAKUBITRIIL/VALSARTAAN;REG NO/DATE: EU/1/15/1058 23.11.2015
1948158	PA2016017,C1948158	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1948158	132016000051118	Italy		PRODUCT NAME: SACUBITRIL/VALSARTAN, COME SACUBITRIL VALSARTAN COMPLESSO DI SALE SODICO (TRISODIO (3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOSSICARBONIL-1-BUTILCARBAMMOIL)PROPIONATO-(S)-3'-METIL-2'-(PENTANOIL(2"-(TETRAZOL-5-ILATO)BIFENIL-4'-ILMETIL)AMMINO)BUTIRRATO) EMIPENTAIDRATO)(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058, 20151123
1467728	340 5007-2016	Slovakia		PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION 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
1467728	93074	Luxembourg		PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123