Pharsight

Entresto is owned by Novartis Pharms Corp.

Entresto contains Sacubitril; Valsartan.

Entresto has a total of 16 drug patents out of which 2 drug patents have expired.

Expired drug patents of Entresto are:

US8404744
US8796331

Entresto was authorised for market use on 07 July, 2015.

Entresto is available in tablet;oral dosage forms.

Entresto can be used as treatment of heart failure, 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, treatment of heart failure with preserved ejection fraction.

The generics of Entresto are possible to be released after 09 May, 2036.

Application	Filing Date	Opposition Party	Legal Status
EP13750725A	2022-01-28	STADA Arzneimittel AG	Revoked
EP13750725A	2022-01-28	Generics [UK] Limited	Revoked
EP13750725A	2022-01-28	Algemeen Octrooi- en Merkenbureau B.V.	Revoked
EP13750725A	2022-01-27	Teva Pharmaceutical Industries Ltd	Revoked
EP13750725A	2022-01-27	Wuesthoff & Wuesthoff Patentanwälte PartG mbB	Revoked
EP13750725A	2022-01-26	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP10176094A	2021-04-15	Krka, d.d., Novo mesto	Granted and Under Opposition
EP10176094A	2021-04-15	betapharm Arzneimittel GmbH	Granted and Under Opposition
EP10176094A	2021-04-15	ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.	Granted and Under Opposition
EP10176094A	2021-04-15	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP10176094A	2021-04-14	D Young & Co LLP	Granted and Under Opposition
EP10176094A	2021-04-14	STADA Arzneimittel AG	Granted and Under Opposition
EP10176094A	2021-04-07	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP10176094A	2021-01-19	Generics [UK] Limited	Granted and Under Opposition
EP06827689A	2014-10-29	Maiwald Patentanwalts GmbH	Opposition rejected
EP03704413A	2008-05-21	Mundipharma GmbH	Opposition procedure closed

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US8101659	August, 2020	Terminated-Denied	Novartis Pharmaceuticals Corporation	Biocon Pharma Limited

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8877938	NOVARTIS PHARMS CORP	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	May, 2027 (4 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8404744	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2023 (2 months ago)
US8796331	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2023 (2 months ago)
US8404744 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2023 (3 months from now)
US8796331 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2023 (3 months from now)
US7468390	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Nov, 2023 (8 months from now)
US7468390 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	May, 2024 (1 year, 2 months from now)
US8101659	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jan, 2025 (1 year, 9 months from now)
US8101659 (Pediatric)	NOVARTIS PHARMS CORP	Methods of treatment and pharmaceutical composition	Jul, 2025 (2 years from now)
US9388134	NOVARTIS PHARMS CORP	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	Nov, 2026 (3 years from now)
US9388134 (Pediatric)	NOVARTIS PHARMS CORP	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	May, 2027 (4 years from now)
US8877938 (Pediatric)	NOVARTIS PHARMS CORP	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	Nov, 2027 (4 years from now)
US9937143	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (10 years from now)
US9517226	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (10 years from now)
US11135192	NOVARTIS PHARMS CORP	Inhibitors for treating diseases characterized by atrial enlargement or remodeling	Aug, 2033 (10 years from now)
US11058667	NOVARTIS PHARMS CORP	Sacubitril-valsartan dosage regimen for treating heart failure	May, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
M (M)	Feb 16, 2024
Pediatric Exclusivity (PED)	Apr 1, 2023

Drugs and Companies using SACUBITRIL; VALSARTAN ingredient

Market Authorisation Date: 07 July, 2015

Treatment: Treatment of heart failure; Treatment of heart failure with preserved ejection fraction; Treating chronic heart failure with reduced ejection fraction in patients not taking an ace inhibitor or an arb...

Dosage: TABLET;ORAL