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Last Updated: May 27, 2022

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 is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-five patent family members in forty-one 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 three 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 Generic Entry Opportunity 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
Horng ChenPhase 1/Phase 2
Samsung Medical CenterPhase 2
Novartis PharmaceuticalsN/A

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 ten US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ENTRESTO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION

FDA Regulatory Exclusivity protecting ENTRESTO

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 207620-003 Jul 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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:

European Patent Office

Patent: 94283
Estimated Expiration: See Plans and Pricing

Japan

Patent: 76469
Estimated Expiration: See Plans and Pricing

Patent: 18519266
Estimated Expiration: See Plans and Pricing

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
Japan 2015526458 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 See Plans and Pricing
Taiwan I554504 See Plans and Pricing
Taiwan 200803834 Organic compounds See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ENTRESTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 122021000003 Germany See Plans and Pricing PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YL)-METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA 3 * X H 2 0, WORIN X 0 BIS 3 IST; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828 2021C/502 Belgium See Plans and Pricing 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
2340828 CA 2021 00001 Denmark See Plans and Pricing PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. NO/DATE: EU/1/15/1058 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.