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Last Updated: November 4, 2024

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ENTRESTO Drug Patent Profile


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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. Two 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 28th, 2024.

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Drug patent expirations by year for ENTRESTO
Drug Prices for ENTRESTO

See drug prices for ENTRESTO

Recent Clinical Trials for ENTRESTO

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

SponsorPhase
Dr. Reddy's Laboratories (Thailand) LimitedPhase 1
Instituto Nacional de Cardiologia Ignacio ChavezPhase 2/Phase 3
Boehringer Ingelheim laboratoryPhase 2/Phase 3

See all ENTRESTO clinical trials

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

Sacubitril-valsartan dosage regimen for treating heart failure
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE

Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

Methods of treatment and pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treatment and pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

FDA Regulatory Exclusivity protecting ENTRESTO

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷  Sign Up

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 0230480
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 26036
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 94283
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 94283
Patent: SCHÉMA POSOLOGIQUE DU SACUBITRIL-VALSARTAN POUR LE TRAITEMENT DE L'INSUFFISANCE CARDIAQUE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷  Sign Up

Patent: 12152
Patent: SCHÉMA POSOLOGIQUE DU SACUBUTRIL-VALSARTAN POUR LE TRAITEMENT DE L'INSUFFISANCE CARDIAQUE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 94283
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 62195
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 76469
Estimated Expiration: ⤷  Sign Up

Patent: 18519266
Patent: 心不全の治療のためのサクビトリル−バルサルタンの用量計画
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 94283
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 94283
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 94283
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 242
Patent: REŽIM DOZIRANJA SAKUBITRIL-VALSARTANA ZA LEČENJE SRČANE INSUFICIJENCIJE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 94283
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 45866
Estimated Expiration: ⤷  Sign Up

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
New Zealand 594006 Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor ⤷  Sign Up
South Korea 101432821 ⤷  Sign Up
Japan 2022020624 心房拡大又はリモデリングを特徴とする疾患を治療するためのNEP阻害剤 ⤷  Sign Up
Brazil 122013025375 compostos orgânicos, seus métodos de preparo e uso, bem como composições farmacêuticas ⤷  Sign Up
Canada 2472399 COMPOSITIONS PHARMACEUTIQUES A BASE DE VALSARTAN ET D'INHIBITEURS NEP (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS) ⤷  Sign Up
Brazil PI0605921 compostos orgánicos ⤷  Sign Up
Taiwan I634887 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ENTRESTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 2021C/502 Belgium ⤷  Sign Up 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
1948158 1690020-1 Sweden ⤷  Sign Up 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 C01467728/01 Switzerland ⤷  Sign Up PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1948158 300810 Netherlands ⤷  Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1467728 340 5007-2016 Slovakia ⤷  Sign Up PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1467728 16C0019 France ⤷  Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2340828 PA2021502 Lithuania ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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