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 fifty-nine 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
Summary for ENTRESTO
International Patents: | 159 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 13 |
Clinical Trials: | 40 |
Patent Applications: | 25 |
Formulation / Manufacturing: | see details |
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 |


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
Sponsor | Phase |
---|---|
Boehringer Ingelheim laboratory | Phase 2/Phase 3 |
Instituto Nacional de Cardiologia Ignacio Chavez | Phase 2/Phase 3 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
Pharmacology for ENTRESTO
Drug Class | Angiotensin 2 Receptor Blocker Neprilysin Inhibitor |
Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ENTRESTO
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 two FDA Regulatory Exclusivities.
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
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
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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
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 |
---|---|---|---|
Hungary | S1600025 | ⤷ Try a Trial | |
Hungary | E054885 | ⤷ Try a Trial | |
European Patent Office | 4212152 | SCHÉMA POSOLOGIQUE DU SACUBUTRIL-VALSARTAN POUR LE TRAITEMENT DE L'INSUFFISANCE CARDIAQUE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE) | ⤷ Try a Trial |
Brazil | 112015003067 | inibidores de nep para tratar doenças caracterizadas por alargamento ou remodelagem atrial | ⤷ Try a Trial |
Norway | 337288 | ⤷ 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 | 93074 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123 |
2340828 | CA 2021 00001 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. NO/DATE: EU/1/15/1058 20151123 |
1948158 | PA2016017 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
1948158 | 2016C/026 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
1948158 | C 2016 017 | Romania | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, SUB FORMA DE COMPLEX DE SARURI DE SODIU; NATIONAL AUTHORISATION NUMBER: EU/1/15/1058/001-016; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1058/001-016; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |