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 eleven 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. Seven 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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Summary for ENTRESTO
International Patents: | 163 |
US Patents: | 7 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 13 |
Clinical Trials: | 41 |
Patent Applications: | 166 |
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 |


Recent Clinical Trials for ENTRESTO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Reddy's Laboratories (Thailand) Limited | Phase 1 |
Boehringer Ingelheim laboratory | Phase 2/Phase 3 |
Instituto Nacional de Cardiologia Ignacio Chavez | Phase 2/Phase 3 |
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 seven US patents.
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 for Free
Cyprus
Patent: 26036
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 94283
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Finland
Patent: 94283
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 62195
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 76469
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Lithuania
Patent: 94283
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 94283
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 94283
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 242
Patent: REŽIM DOZIRANJA SAKUBITRIL-VALSARTANA ZA LEČENJE SRČANE INSUFICIJENCIJE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 94283
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 45866
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Spain | 2945866 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2007056546 | ⤷ Try for Free | |
Japan | 7407508 | ⤷ Try for Free | |
Peru | 20070803 | COMBINACION FARMACEUTICA DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA | ⤷ Try for Free |
European Patent Office | 1948158 | COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR) | ⤷ Try for Free |
Finland | 3294283 | ⤷ Try for Free | |
Ecuador | SP14019136 | COMBINACIONES FARMACÉUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA (NEP) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1948158 | 16C0018 | France | ⤷ Try for Free | PRODUCT NAME: SACUBITRIL/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'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
1948158 | 300810 | Netherlands | ⤷ Try for Free | 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 |
1948158 | 93075 | Luxembourg | ⤷ Try for Free | 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 | 340 5007-2016 | Slovakia | ⤷ Try for Free | PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
1948158 | 122016000038 | Germany | ⤷ Try for Free | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
1948158 | C 2016 017 | Romania | ⤷ Try for Free | 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 |
1948158 | C01948158/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: SACUBITRIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for the Drug: Entresto
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