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Last Updated: March 29, 2024

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ENTRESTO Drug Patent Profile


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Which patents cover Entresto, and what generic alternatives are available?

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

This drug has one hundred and sixty-two 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. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.

DrugPatentWatch® Generic Entry Outlook for Entresto

Entresto was eligible for patent challenges on July 7, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 9, 2036. This may change due to patent challenges or generic licensing.

There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ENTRESTO
Drug Prices for ENTRESTO

See drug prices for ENTRESTO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ENTRESTO
Generic Entry Date for ENTRESTO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ENTRESTO

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

SponsorPhase
Boehringer Ingelheim laboratoryPhase 2/Phase 3
Instituto Nacional de Cardiologia Ignacio ChavezPhase 2/Phase 3
Brigham and Women's HospitalPhase 2

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ENTRESTO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ENTRESTO

Sacubitril-valsartan dosage regimen for treating heart failure
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

Methods of treatment and pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treatment and pharmaceutical composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

FDA Regulatory Exclusivity protecting ENTRESTO

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷  Try a Trial

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 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-002 Jul 7, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Cyprus

Patent: 26036
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Patent: 12152
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 62195
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 76469
Estimated Expiration: ⤷  Try a Trial

Patent: 18519266
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 242
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 94283
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 45866
Estimated Expiration: ⤷  Try a Trial

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
Taiwan I554504 ⤷  Try a Trial
Portugal 3294283 ⤷  Try a Trial
Hungary E054885 ⤷  Try a Trial
Slovenia 2340828 ⤷  Try a Trial
Denmark 2340828 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ENTRESTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1467728 C01467728/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
2340828 301088 Netherlands ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1948158 132016000051118 Italy ⤷  Try a Trial 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 1690021-9 Sweden ⤷  Try a Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
1948158 CA 2016 00023 Denmark ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.